DE102019200595B3 - DEVICE WITH PROTECTION LEVEL AREA FOR DIRECTLY OR INDIRECTLY DETECTING ONE OR MORE BIOSE SUBSTANCES OR ONE OR MORE SUBSTANCES IN AT LEAST ONE SAMPLE THAT MAY CONTAIN A BIOS SUBSTANCE - Google Patents

Abstract

A device for the direct or indirect detection of one or more substances in at least one sample comprises at least one closed chamber which has at least one lockable access, at least one automatic measuring device arranged in the chamber for the automatic direct or indirect detection of one or more substances in the at least one Sample, at least one inactivating device for inactivating biological substances arranged in the chamber, at least one automatic handling device arranged in the chamber, which is designed to receive the sample and to move the sample or a sample material to the measuring device, and at least one controller, which is associated with the lockable access, the measuring device, the inactivation device and the handling device. The controller operates to control the automatic handler to pick up the sample, hermetically lock the lockable access to prevent external access to the chamber after the sample has been introduced into the chamber and until the sample has been deactivated To actuate the handling device to move the sample or the sample material to the measuring device, to actuate the measuring device to carry out an analysis of the sample or the sample material, to actuate the inactivation device to bring about inactivation of biological substances, and to unlock the lockable access after the inactivation to allow external access to the chamber for taking the sample from the chamber.

Description

The present invention relates to the field of the investigation of substances, for example for the detection of pathogenic substances in one or more samples from an organism, for example a human or animal organism, and / or from an object, for example a soil sample or a hygiene swab from surfaces , was obtained. In particular, the present application relates to a device for the direct or indirect detection of one or more substances in a sample, which may contain a biological substance, or for the direct or indirect detection of one or more biological substances in a sample.

1. 1. Mikroorganismen, Zellkulturen und Endoparasiten einschließlich ihrer gentechnisch veränderten Formen,
2. 2. mit Transmissibler Spongiformer Enzephalopathie (TSE) assoziierte Agenzien,

die den Menschen durch Infektionen, übertragbare Krankheiten, Toxinbildung, sensibilisierende oder sonstige, die Gesundheit schädigende Wirkungen gefährden können.According to the Organic Substances Ordinance, BioStoffV, 2013, which is based on the implementation of Council Directive 2010/32 / EU of May 10, 2010, organic substances are

1. 1. microorganisms, cell cultures and endoparasites including their genetically modified forms,
2. 2. agents associated with transmissible spongiform encephalopathy (TSE),

that can endanger humans through infections, communicable diseases, toxin formation, sensitizing or other health-damaging effects.

• Risikogruppe 1 (RG1): Biostoffe, bei denen es unwahrscheinlich ist, dass sie beim Menschen eine Krankheit hervorrufen,
• Risikogruppe 2 (RG2): Biostoffe, die eine Krankheit beim Menschen hervorrufen können und eine Gefahr für Beschäftigte darstellen könnten; eine Verbreitung in der Bevölkerung ist unwahrscheinlich; eine wirksame Vorbeugung oder Behandlung ist normalerweise möglich,
• Risikogruppe 3 (RG3): Biostoffe, die eine schwere Krankheit beim Menschen hervorrufen und eine ernste Gefahr für Beschäftigte darstellen können; die Gefahr einer Verbreitung in der Bevölkerung kann bestehen, doch ist normalerweise eine wirksame Vorbeugung oder Behandlung möglich,
• Risikogruppe 4 (RG4): Biostoffe, die eine schwere Krankheit beim Menschen hervorrufen und eine ernste Gefahr für Beschäftigte darstellen; die Gefahr einer Verbreitung in der Bevölkerung ist unter Umständen groß; normalerweise ist eine wirksame Vorbeugung oder Behandlung nicht möglich.

Biological substances, such as bacteria, viruses and fungi, are ubiquitous in the environment. Some of these bio-substances have the ability to cause diseases in humans. According to the current state of science, biological agents are classified in one of the following risk groups, RG, according to their risk of infection:

• Risk group 1 (RG1): Biological substances that are unlikely to cause disease in humans,
• Risk group 2nd (RG2): Biological substances that can cause an illness in humans and could pose a danger to employees; spreading among the population is unlikely; effective prevention or treatment is usually possible
• Risk group 3rd (RG3): Biological substances that cause a serious illness in humans and can pose a serious danger to employees; There may be a risk of spreading in the population, but effective prevention or treatment is usually possible
• Risk group 4th (RG4): Biological substances that cause a serious illness in humans and represent a serious danger for employees; the risk of spreading among the population may be great; Effective prevention or treatment is usually not possible.

The Infection Protection Act (IfSG - Law for the Prevention and Control of Infectious Diseases in Humans) and the Biological Substances Ordinance (BioStoffV, Occupational Safety) specify legal requirements and regulate the handling of biological substances. According to the BioStoffV, activities with biological substances may only be carried out in the protection level areas provided for this purpose, i.e. laboratories or comparable facilities. Depending on the classification of the biological substances in risk groups, certain protective measures have to be taken. This essentially includes structural measures, access restrictions, technical specifications such as B. constant negative pressure in the protection level area, filtration of supply and exhaust air, sealability for the purpose of fumigation, hygienic aspects, storage of biological substances under lock and key, the presence of sterilization units and options for safe disposal, as specified, for example, in Annex II of the BioStoffV.

Activities with such biological substances have so far been carried out in approved laboratories. In classic, chemical-microbiological diagnostic laboratories, e.g. B. systems for identifying bacteria or for determining sensitivity to antibiotics, e.g. B. Vitek2, BioMerieux, Phoenix, Becton Dickinson. The laboratories have a corresponding protection level area and usually an inactivation unit, e.g. B. in the form of an autoclave. The activities with the organic substances are carried out by appropriately trained personnel. The Ordinance on Biological Substances regulates the measures to protect personnel when working with biological agents or biological substances according to the risk group in which a biological substance is classified, in accordance with §3 BioStoffV.

Outside of the above-mentioned laboratories or comparable facilities with a corresponding protection area, activities with biological substances are not permitted according to the BiostoffV.

In special situations, such as an Ebola outbreak, field laboratories are set up at the site of the outbreak. In such situations, it is a major challenge to create a safe working environment for employees and personnel when dealing with biological substances, especially when dealing with biological substances of the higher risk groups, for example the risk group 4th . The risk group 4th includes organic substances that are heavy Cause disease in humans and pose a serious risk to workers, although the risk of spreading among the population may be high and effective prevention or treatment may not be possible. In crisis areas, this is aggravated by the fact that there may be no reliable electricity and / or water supply or waste disposal. This problem could be solved by not carrying out the investigation on site, but instead sending the potentially infectious material to one or more international reference laboratories, however, such transport of potentially infectious material involves further dangers. On the one hand, the likelihood that pathogens can be detected in the test material or sample material decreases the longer the time between sample collection and examination of the sample. The actual shipping also harbors dangers, for example that the potentially infectious material is released due to an accident or incorrect handling during transport. For this reason, and above all because of the enormous time advantage (it takes significantly less time until a result is available), such potentially infectious samples are not sent, and an investigation at the site of the outbreak is preferred, for example in the above-mentioned field laboratories.

Various approaches for realizing such field laboratories are known in the state of the art, for example in the form of a mobile container laboratory which, for example, has the highest safety standard for examining biological substances of the risk group 4th Fulfills. This is a mobile unit, for example with the dimensions of an ISO container, which has the actual laboratory room with the equipment for sample preparation / sample analysis contained therein, which is entered by one or more employees so that the employee within the sample room can access the Can perform sample preparation / examination. In addition, a decontamination shower can be provided. Such a container laboratory is mobile and can be moved to the place of use by means of ships and / or vehicles and can be entered there by the employees in order to carry out the necessary examinations. Examples of such container laboratories are in the WO 03/088886 A1 , of the WO 2015/079273 A1 , of the US 7,985,382 B1 , of the CN 203 683 155 U. and the CN 102 795 146 A. described.

Such mobile container laboratories allow the examination of the potentially infectious material on site by appropriately trained personnel who work in the laboratory, but despite their mobility, these laboratories are only complex using appropriate transport mechanisms, such as cranes, transport vehicles, ships, movable, which is associated with a corresponding logistical effort. Furthermore, it is necessary that the trained personnel is also on site in order to carry out the necessary examinations in the laboratory set up, so that the corresponding laboratories must also meet the corresponding requirements for the protection of the employees.

Measurement systems are also known in the prior art which carry out automatic sample preparation and sample analysis, for example the system from Cepheid known under the brand GenExpert. Such systems work with prepared cartridges which contain, for example, all reagents for the detection and / or preparation of the sample before the actual analysis. After removal, the sample is placed in the cartridge and then made available to the automatic system for analysis, which outputs the results of the analysis. However, these are systems which are not suitable for the examination of samples, which may possibly contain biological substances, since none of the necessary protective functions, for example to protect the person who uses the system, against biological substances of the risk group 4th provide. For the investigation of such biological substances, but also of biological substances of the risk groups 1 to 3rd Such an automatic test system would in principle be usable, but only within the existing laboratories approved for handling such samples or within the above-mentioned mobile laboratories. In other words, such an automatic system can, for example, be part of the apparatus that is located within the laboratory in which the employees examine the biological substances.

The situation summarized above in connection with the examination of samples, which may possibly contain biological substances, is disadvantageous in that the examination of such samples or of potentially infectious material, which may contain biological substances of the different risk groups, requires at least RG2 to use appropriately equipped laboratories that take the necessary protective measures for the people employed in them to examine the samples. Although the above-mentioned problems in connection with the dispatch of infectious material can be solved by using mobile container laboratories, these still require the use of employees within the laboratory space, so that in addition to the logistical effort to move the container laboratories to them appropriate locations also the use of appropriately trained Personnel is required. The requirements for logistics and / or for personnel may not be readily achievable at any location where an examination of infectious material is to be carried out.

Starting from the prior art outlined above, the present invention is based on the object of creating an approach which makes it possible in a simple manner to investigate samples which may possibly contain a biological substance.

This object is achieved by a device according to the independent patent claims.

• zumindest eine geschlossene Kammer, die zumindest einen verschließbaren Zugang aufweist,
• zumindest eine in der Kammer angeordnete automatische Messvorrichtung zum automatischen direkten oder indirekten Nachweis eines oder mehrerer Stoffe in der zumindest einen Probe,
• zumindest eine in der Kammer angeordnete Inaktivierungsvorrichtung zum Inaktivieren von Biostoffen,
• zumindest eine in der Kammer angeordnete automatischen Handhabungsvorrichtung, die ausgebildet ist, die Probe aufzunehmen, und die Probe oder ein Probenmaterial zu der Messvorrichtung zu bewegen, und
• zumindest eine Steuerung, die mit dem verschließbaren Zugang, der Messvorrichtung, der Inaktivierungsvorrichtung und der Handhabungsvorrichtung verbunden ist, wobei die Steuerung wirksam ist, um
  • • die automatische Handhabungsvorrichtung anzusteuern, um die Probe aufzunehmen,
  • • den verschließbaren Zugang hermetisch zu verriegeln, um nach einem Einbringen der Probe in die Kammer und bis zur Inaktivierung der Probe einen Zugriff auf die Kammer von außen zu verhindern,
  • • die automatische Handhabungsvorrichtung anzusteuern, um die Probe oder das Probenmaterial zu der Messvorrichtung zu bewegen,
  • • die Messvorrichtung anzusteuern, um eine Analyse der Probe oder des Probenmaterials durchzuführen,
  • • die Inaktivierungsvorrichtung anzusteuern, um eine Inaktivierung von Biostoffen zu bewirken, und
  • • den verschließbaren Zugang nach der Inaktivierung zu entriegeln, um einen Zugriff auf die Kammer von außen zur Entnahme der Probe aus der Kammer zu ermöglichen.

The present invention provides a device for the direct or indirect detection of one or more substances in at least one sample, the device comprising the following features:

• at least one closed chamber which has at least one lockable access,
• at least one automatic measuring device arranged in the chamber for automatic direct or indirect detection of one or more substances in the at least one sample,
• at least one inactivation device arranged in the chamber for inactivating biological substances,
• at least one automatic handling device arranged in the chamber, which is designed to receive the sample and to move the sample or a sample material to the measuring device, and
• at least one controller connected to the lockable access, the measuring device, the inactivating device and the handling device, the controller being effective to
  • Control the automatic handling device to take up the sample,
  • Hermetically lock the lockable access in order to prevent external access to the chamber after the sample has been introduced into the chamber and until the sample has been inactivated,
  • Control the automatic handling device in order to move the sample or the sample material to the measuring device,
  • Control the measuring device in order to carry out an analysis of the sample or the sample material,
  • Triggering the inactivation device in order to inactivate biological substances, and
  • • unlock the lockable access after inactivation to allow external access to the chamber for taking the sample from the chamber.

• zumindest einer geschlossenen Kammer, die zumindest einen verschließbaren Zugang aufweist,
• zumindest einer in der Kammer angeordneten Aufnahme, die vorbereitet ist, um eine automatische Messvorrichtung zum automatischen direkten oder indirekten Nachweis eines oder mehrerer Stoffe in zumindest einer Probe aufzunehmen,
• zumindest einer in der Kammer angeordneten Inaktivierungsvorrichtung zum Inaktivieren von Biostoffen,
• zumindest einer in der Kammer angeordneten automatischen Handhabungsvorrichtung, die ausgebildet ist, die Probe oder das Probenmaterial aufzunehmen, und die Probe oder das Probenmaterial zu bewegen, und
• zumindest einer Steuerung, die mit dem verschließbaren Zugang, der Inaktivierungsvorrichtung und der Handhabungsvorrichtung verbunden ist, wobei die Steuerung wirksam ist, um
  • • die automatische Handhabungsvorrichtung anzusteuern, um die Probe aufzunehmen,
  • • den verschließbaren Zugang hermetisch zu verriegeln, um nach einem Einbringen der Probe in die Kammer und bis zur Inaktivierung der Probe einen Zugriff auf die Kammer von außen zu verhindern,
  • • die automatische Handhabungsvorrichtung anzusteuern, um die Probe oder das Probenmaterial in der Kammer zu bewegen,
  • • die Inaktivierungsvorrichtung anzusteuern, um eine Inaktivierung von Biostoffen zu bewirken, und
  • • den verschließbaren Zugang nach der Inaktivierung zu entriegeln, um einen Zugriff auf die Kammer von außen zur Entnahme der Probe aus der Kammer zu ermöglichen,
  wobei die Steuerung mit einer in der Aufnahme aufgenommenen Messvorrichtung verbindbar ist, um die Messvorrichtung anzusteuern, um eine Analyse der Probe oder des Probenmaterials durchzuführen.

The present invention provides an apparatus with

• at least one closed chamber which has at least one lockable access,
• at least one receptacle arranged in the chamber, which is prepared to receive an automatic measuring device for the automatic direct or indirect detection of one or more substances in at least one sample,
• at least one inactivation device arranged in the chamber for inactivating biological substances,
• at least one automatic handling device arranged in the chamber, which is designed to receive the sample or the sample material and to move the sample or the sample material, and
• at least one controller connected to the lockable access, inactivation device and handling device, the controller being operative to
  • Control the automatic handling device to take up the sample,
  • Hermetically lock the lockable access in order to prevent external access to the chamber after the sample has been introduced into the chamber and until the sample has been inactivated,
  • To control the automatic handling device in order to move the sample or the sample material in the chamber,
  • Triggering the inactivation device in order to inactivate biological substances, and
  • Unlock the lockable access after inactivation to allow external access to the chamber for taking the sample from the chamber,
  wherein the controller can be connected to a measuring device accommodated in the receptacle in order to control the measuring device in order to carry out an analysis of the sample or the sample material.

The present invention avoids the problems set out in the prior art in connection with the potential dispatch of infectious material or the problems in connection with the setting up of mobile laboratories by creating a device which can be readily used by non-trained laboratory personnel, for example by Doctors, nurses or other helpers can be operated, whereby at the same time the minimum requirements for handling biological substances of the above-mentioned risk groups are given. In other words, exemplary embodiments of the invention create a mini-bio-laboratory (also called MBSL laboratory - MBSL = Mobile Bio Safety Level) or mini-bio-laboratory with the minimum requirements for the handling of bio-substances in that an examination can be carried out within a closed chamber without a user of the device having to intervene. The actual laboratory room is not entered by the user, so that the user is safely protected against potentially released biological substances during the analysis. Through the provision of the automatic handling device according to the invention, the sample is received and processed for analysis within the closed chamber and then deactivated to inactivate potentially biologically present substances in the sample, as required by the BioStoffV or other equivalent regulations in other countries. The device according to the invention thus requires no access by people or employees in the actual laboratory room, which only the necessary analysis devices and a handling device, for. B. in the form of a robot, so that the laboratory space can be dimensioned small, so that it can be dimensioned so that it cannot be entered by a person. This enables the device according to the invention to be designed with dimensions and a weight (for example up to 50 kg), so that the device as a whole can be carried by the user and can be brought to a desired location and used there without logistical effort.

According to exemplary embodiments, a mobile device is thus created which can also be used on site as a closed system with a protection level range or taking into account protective measures for activities involving biological substances outside of one of the defined laboratory environments described above, which can also be referred to as a mini-laboratory with a protection level range .

The device according to the invention can either already be equipped with one or more measuring devices or one or more automatic measuring devices in order to carry out certain analyzes of a sample. In other configurations, the device can be equipped such that measuring devices can be arranged interchangeably in the closed chamber, which has the advantage that the device can be equipped with suitable measuring devices depending on the material to be examined, for example by the user of the device, who arranges the corresponding measuring devices of the measuring devices in the chamber before he leaves for the place of use.

• • die Vorrichtung umfasst eine Desinfektionsvorrichtung zum Desinfizieren eines Kammerinnenraums und der darin angeordneten Vorrichtungen, wobei die Kammer und die darin angeordneten Vorrichtungen Oberflächen aufweisen, die bezüglich des verwendeten Desinfizierungsverfahrens beständig sind,
• • die Vorrichtung umfasst eine Belüftungsvorrichtung, die ausgebildet ist, um in der Kammer, zumindest zwischen dem Verriegeln und dem Entriegeln des Zugangs, einen ständigen Unterdruck aufrechtzuerhalten, wobei die Belüftungsvorrichtung ausgebildet ist, um Luft in die Kammer zuzuführen und um Luft aus der Kammer abzuführen, und wobei die Belüftungsvorrichtung ein oder mehrere Filter umfasst und ausgebildet ist, um die Zuluft und/oder die Abluft durch das Filter, z.B. ein Hochleistungsschwebstoff-Filter, zu führen,
• • die Vorrichtung umfasst eine Notstromversorgung, beispielsweise in Form einer Batterie oder eines eigenständig arbeitenden Stromaggregats, z.B. einen mit Brennstoff betriebenen Generator, einen Solargenerator, einen Windgenerator oder einen Wasserkraftgenerator,
• • der verschließbare Zugang umfasst eine Schleuse mit gegeneinander verriegelbaren Türen,
• • die Inaktivierungsvorrichtung umfasst einen Autoklav oder eine gleichwertige Sterilisationseinheit,
• • die Inaktivierungsvorrichtung ist ferner ausgebildet, um kontaminierte feste und flüssige Abfälle vor der Entnahme aus der Kammer zu inaktivieren,
• • die Inaktivierungsvorrichtung ist ferner ausgebildet, um Abwässer vor der Entnahme aus der Kammer zu inaktivieren,
• • der Kammerboden der Kammer ist fluidundurchlässig, und
• • die Kammerinnenwände und die Kammerdecke der Kammer sind fluidundurchlässig.

Exemplary embodiments create a device that has one or more of the following features:

• The device comprises a disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used,
• The device comprises a ventilation device which is designed to maintain a constant negative pressure in the chamber, at least between the locking and unlocking of the access, the ventilation device being designed to supply air into the chamber and to remove air from the chamber , and wherein the ventilation device comprises one or more filters and is designed to guide the supply air and / or the exhaust air through the filter, for example a high-performance suspended matter filter,
• The device comprises an emergency power supply, for example in the form of a battery or an independently operating power unit, for example a fuel-operated generator, a solar generator, a wind generator or a hydropower generator,
• The lockable access includes a lock with interlocking doors,
• The inactivation device comprises an autoclave or an equivalent sterilization unit,
• The inactivation device is also designed to inactivate contaminated solid and liquid waste before removal from the chamber,
• The inactivation device is also designed to inactivate waste water before removal from the chamber,
• • the chamber floor of the chamber is fluid impermeable, and
• • The chamber inner walls and the chamber ceiling of the chamber are impermeable to fluids.

According to this exemplary embodiment, the device according to the invention is supplemented by one or more of the units specified above in order to implement additional protective measures, such as are known, for example, from the BioStoffV, for example the protective measures 2nd , 4th and 5 , 9 , 11 and 13 , 12 , 16 , 17th and or 21st according to Appendix II of the BioStoffV.

Exemplary embodiments provide a device with a disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used.

According to this exemplary embodiment, a device is created which contains the protective measures for handling biological substances of the risk group which are binding according to the BioStoffV 2nd includes, for example, protective measures 11 and 13 according to Annex II BioStoffV.

• • die Vorrichtung umfasst eine Notstromversorgung, beispielsweise in Form einer Batterie oder eines eigenständig arbeitenden Stromaggregats, z.B. einen mit Brennstoff betriebenen Generator, einen Solargenerator, einen Windgenerator oder einen Wasserkraftgenerator,
• • die Inaktivierungsvorrichtung umfasst einen Autoklav oder eine gleichwertige Sterilisationseinheit,
• • die Inaktivierungsvorrichtung ist ferner ausgebildet, um kontaminierte feste und flüssige Abfälle vor der Entnahme aus der Kammer zu inaktivieren.

Exemplary embodiments create a device that has one or more of the following features:

• The device comprises an emergency power supply, for example in the form of a battery or an independently operating power unit, for example a fuel-operated generator, a solar generator, a wind generator or a hydropower generator,
• The inactivation device comprises an autoclave or an equivalent sterilization unit,
• • The inactivation device is also designed to inactivate contaminated solid and liquid waste before removal from the chamber.

According to this exemplary embodiment, the device additionally comprises one or more of those in the Annex II of the BioStoffV in connection with the handling of biological substances of the risk group 2nd specified optional protective measures, namely the protective measures 9 , 16 or 21st .

Embodiments create a device

• A disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used,
• Wherein the inactivation device is further configured to inactivate contaminated solid and liquid waste prior to removal from the chamber, and
• • At least the chamber floor of the chamber is fluid impermeable.

According to this exemplary embodiment, the device comprises the binding protective measures described in Appendix II of the BioStoffV for handling biological substances of the risk group 3rd are specified, namely the protective measures 11 and 13 , 12 and 16 .

• • die Vorrichtung umfasst eine Belüftungsvorrichtung, die ausgebildet ist, um in der Kammer, zumindest zwischen dem Verriegeln und dem Entriegeln des Zugangs, einen ständigen Unterdruck aufrechtzuerhalten, wobei die Belüftungsvorrichtung ausgebildet ist, um Luft in die Kammer zuzuführen und um Luft aus der Kammer abzuführen, und wobei die Belüftungsvorrichtung ein oder mehrere Filter umfasst und ausgebildet ist, um die Zuluft und/oder die Abluft durch das Filter, z.B. ein Hochleistungsschwebstoff-Filter, zu führen,
• • die Vorrichtung umfasst eine Notstromversorgung, beispielsweise in Form einer Batterie oder eines eigenständig arbeitenden Stromaggregats, z.B. einen mit Brennstoff betriebenen Generator, einen Solargenerator, einen Windgenerator oder einen Wasserkraftgenerator,
• • der verschließbare Zugang umfasst eine Schleuse mit gegeneinander verriegelbaren Türen,
• • die Inaktivierungsvorrichtung umfasst einen Autoklav oder eine gleichwertige Sterilisationseinheit,
• • die Inaktivierungsvorrichtung ist ferner ausgebildet, um Abwässer vor der Entnahme aus der Kammer zu inaktivieren.

Exemplary embodiments create a device that has one or more of the following features:

• The device comprises a ventilation device which is designed to maintain a constant negative pressure in the chamber, at least between the locking and unlocking of the access, the ventilation device being designed to supply air into the chamber and to remove air from the chamber , and wherein the ventilation device comprises one or more filters and is designed to guide the supply air and / or the exhaust air through the filter, for example a high-performance suspended matter filter,
• The device comprises an emergency power supply, for example in the form of a battery or an independently operating power unit, for example a fuel-operated generator, a solar generator, a wind generator or a hydropower generator,
• The lockable access includes a lock with interlocking doors,
• The inactivation device comprises an autoclave or an equivalent sterilization unit,
• • The inactivation device is also designed to inactivate waste water before removal from the chamber.

According to this exemplary embodiment, the device for handling biological substances is of the risk group 3rd supplemented by the optional protective measures specified in Appendix II of the BioStoffV, namely by the protective measures 2nd , 4th and 5 , 9 , 17th or 21st .

• • einer Desinfektionsvorrichtung zum Desinfizieren eines Kammerinnenraums und der darin angeordneten Vorrichtungen, wobei die Kammer und die darin angeordneten Vorrichtungen Oberflächenaufweisen, die bezüglich des verwendeten Desinfizierungsverfahrens beständig sind,
• • einer Belüftungsvorrichtung, die ausgebildet ist, um in der Kammer, zumindest zwischen dem Verriegeln und dem Entriegeln des Zugangs, einen ständigen Unterdruck aufrechtzuerhalten, wobei die Belüftungsvorrichtung ausgebildet ist, um Luft in die Kammer zuzuführen und um Luft aus der Kammer abzuführen, und wobei die Belüftungsvorrichtung ein oder mehrere Filter umfasst und ausgebildet ist, um die Zuluft und/oder die Abluft durch das Filter, z.B. ein Hochleistungsschwebstoff-Filter, zu führen, und
• • einer Notstromversorgung, beispielsweise in Form einer Batterie oder eines eigenständig arbeitenden Stromaggregats, z.B. einen mit Brennstoff betriebenen Generator, einen Solargenerator, einen Windgenerator oder einen Wasserkraftgenerator,
• • wobei der verschließbare Zugang eine Schleuse mit gegeneinander verriegelbaren Türen umfasst,
• • wobei die Inaktivierungsvorrichtung einen Autoklav oder eine gleichwertige Sterilisationseinheit aufweist,
• • wobei die Inaktivierungsvorrichtung ferner ausgebildet ist, um kontaminierte feste und flüssige Abfälle vor der Entnahme aus der Kammer und Abwässer vor der Entnahme aus der Kammer zu inaktivieren, und
• • wobei der Kammerboden, die Kammerinnenwände und die Kammerdecke der Kammer fluidundurchlässig sind.

Embodiments create a device with:

• A disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used,
• A ventilation device configured to maintain a constant negative pressure in the chamber, at least between the locking and unlocking of the access, the ventilation device being designed to supply air into the chamber and to remove air from the chamber, and wherein the ventilation device comprises one or more filters and is designed to lead the supply air and / or the exhaust air through the filter, for example a high-performance suspended matter filter, and
• An emergency power supply, for example in the form of a battery or an independently operating power unit, for example a fuel-operated generator, a solar generator, a wind generator or a hydropower generator,
• The lockable access comprises a lock with interlocking doors,
• Wherein the inactivation device has an autoclave or an equivalent sterilization unit,
• Wherein the inactivation device is further configured to inactivate contaminated solid and liquid waste before removal from the chamber and waste water before removal from the chamber, and
• • whereby the chamber floor, the chamber inner walls and the chamber ceiling of the chamber are impermeable to fluids.

According to this exemplary embodiment, a device is created which contains the binding protective measures for handling biological substances of the risk group specified in the BioStoffV 4th includes, namely the protective measures 2nd , 4th and 5 , 9 , 11 and 13 , 12 , 16 and 17th and 21st .

Thus, exemplary embodiments of the present invention create suitable configurations of the device depending on the examination material to be analyzed, since biological substances of the risk group 2nd require a different structure for the implementation of the protective measures than devices or systems in which a material is to be examined, in the biological substances of the risk group 3rd or 4th may be included or to be expected, for example tuberculosis or plague pathogens, which belong to the risk group 3rd fall, or Lassa or Ebola viruses, in the risk group 4th fall.

Embodiments create a device in which the inactivation device is designed to physically (e.g. thermally, under pressure, by means of ionizing radiation, UV radiation or steam sterilization) or chemically (e.g. with chlorine dioxide, hydrogen peroxide, ozone, sodium hypochlorite, aldehydes, chlorine, iodine) , Phenols, alcohols, ethylene oxide).

Exemplary embodiments create a device in which the control is effective in order to control the measuring device, so that after the introduction of the one or more samples to be examined, the measuring method runs fully automatically according to a programmed measuring protocol.

Embodiments provide a device in which the controller is operative to store the measurement data and results generated by the measuring device for storage or transmission to an external location, e.g. via a wired and / or wireless communication system.

Embodiments create a device in which the control comprises a user interface and / or a data interface for connection to a wired and / or wireless communication system.

• • in-vivo-Methoden, z.B. in Form von Tierversuchen, oder Versuchen mit Pflanzen
• • Zellkultur-basierten oder mikrobiologisch-kulturellen Nachweisverfahren,
• • Protein-chemische, molekularbiologische, immunologische, radiologische, serologische, zytologische, mikrobiologische, parasitologische, virulogische, hämatologische, hämostaseologische, endokrinologische, histologische, klinisch-chemische, chemische und physikalische Methoden,
• • Verfahren zur Empfindlichkeitsprüfung von Biostoffen auf Substanzen wie Antibiotika, z.B. Antibiogramme, Antimycotika, Chemotherapeutika, Zytostatika, Fungizide, Herbizide, Virostatika, neuartige Wirkstoffe und andere Chemikalien,
• • Verfahren mit gentechnisch veränderten Organismen, GVO.

Exemplary embodiments create a device in which the measuring device uses one or more of the following detection methods:

• • in vivo methods, for example in the form of animal experiments or experiments with plants
• • cell culture-based or microbiological-cultural detection methods,
• Protein-chemical, molecular-biological, immunological, radiological, serological, cytological, microbiological, parasitological, virulogical, hematological, haemostaseological, endocrinological, histological, clinical-chemical, chemical and physical methods,
• • Method for testing the sensitivity of biological substances to substances such as antibiotics, for example antibiograms, antimycotics, chemotherapeutics, cytostatics, fungicides, herbicides, antivirals, novel active substances and other chemicals,
• • Process with genetically modified organisms, GMOs.

Embodiments create a device in which the measuring chamber has a sample vessel for holding the sample or the sample material and for receiving one or more reagents, for example detection and / or sample preparation reagents.

• • die Messvorrichtung mit einem Probengefäß zu bestücken, und/oder
• • Reagenzien in das Probengefäß der Messvorrichtung einzubringen.

Ausführungsbeispiele schaffen eine Vorrichtung mit einer Probenvorbereitungsvorrichtung zum Vorbereiten der Probe vor der Messung, z.B. durch Zellaufschluss, Extraktion, Isolation, Anreicherung und/oder Reinigung durch Filtration oder Zentrifugation, Probentransferschritte.Exemplary embodiments provide a device in which the device has one or more reservoirs for the reagents and / or can be equipped with one or more sample vessels in which the reagents are contained, and wherein the control is effective to control the automatic handling device in order to

• • equip the measuring device with a sample vessel, and / or
• • Introduce reagents into the sample vessel of the measuring device.

Exemplary embodiments provide a device with a sample preparation device for preparing the sample before the measurement, for example by cell disruption, extraction, isolation, enrichment and / or cleaning by filtration or centrifugation, sample transfer steps.

• • die automatische Handhabungsvorrichtung anzusteuern, die Probe zu der Probenvorbereitungsvorrichtung zu bewegen,
• • die Probenvorbereitungsvorrichtung anzusteuern, um die Probe oder das Probenmaterial mit einer oder mehreren der Reagenzien zu behandeln oder um die Probe oder das Probenmaterial in ein Probengefäß umzufüllen,
• • die automatische Handhabungsvorrichtung anzusteuern, um die Probe oder das Probenmaterial oder das Probengefäß zu der Messvorrichtung zu bewegen.

Exemplary embodiments provide a device in which the sample preparation device prepares the sample using one or more reagents, for example detection and / or sample preparation reagents, before being fed to the measuring device, wherein the device has one or more reservoirs for the reagents or detection kits has and / or can be equipped with one or more sample vessels in which the reagents, for example in liquid or solid form, are contained, and wherein the controller is connected to the sample preparation device and is effective to

• To control the automatic handling device, to move the sample to the sample preparation device,
• Triggering the sample preparation device in order to treat the sample or the sample material with one or more of the reagents or to transfer the sample or the sample material into a sample vessel,
• Control the automatic handling device in order to move the sample or the sample material or the sample vessel to the measuring device.

Exemplary embodiments provide a device in which the at least one sample is provided in a sample container, the automatic handling device being designed to receive the sample container, to take the sample or the sample material from the sample container, and the sample or the sample material to the measuring device and / or move to the sample preparation device.

• • den Probenbehälter aufzunehmen,
• • die Probe oder das Probenmaterial mit Reagenzien aus dem Probenbehälter zu behandeln bzw. vorzubereiten, und
• • die behandelte bzw. vorbereitete Probe oder das Probenmaterial zu der Messvorrichtung zu der Probenvorbereitungsvorrichtung zu bewegen.

Exemplary embodiments provide a device in which the at least one sample is provided in a sample container, the sample container containing one or more reagents, for example detection and / or sample preparation reagents, the automatic handling device being designed to

• • take up the sample container,
• • treat or prepare the sample or sample material with reagents from the sample container, and
• • move the treated or prepared sample or the sample material to the measuring device to the sample preparation device.

Embodiments provide an apparatus in which the sample container is closed, e.g. with a septum, the automatic handling device being designed to open the sample container.

• • einen verschlossenen Probenbehälter zu öffnen, und/oder
• • die Probe bzw. das Probenmaterial aus dem Probenbehälter zu entnehmen, z.B. mittels einer Kanüle, einer Kapillare oder eines Abstrichprobennehmers, und/oder
• • einen Probentransfer zu der Probenvorbereitungsvorrichtung und/oder zu der Messvorrichtung durchzuführen, und/oder
• • Reagenzien, z.B. Nachweis- und/oder Probenvorbereitungs-Reagenzien, bereitzustellen.

Embodiments create a device in which the handling device is designed to:

• • open a closed sample container, and / or
• • to take the sample or the sample material from the sample container, for example by means of a cannula, a capillary or a smear sampler, and / or
• Perform a sample transfer to the sample preparation device and / or to the measuring device, and / or
• • Provide reagents, eg detection and / or sample preparation reagents.

• • einen verschlossenen Probenbehälter zu öffnen, und/oder
• • die Probe bzw. das Probenmaterial aus dem Probenbehälter zu entnehmen, z.B. mittels einer Kanüle, einer Kapillare oder eines Abstrichprobennehmers, und/oder
• • einen Probentransfer zu der Probenvorbereitungsvorrichtung und/oder zu der Messvorrichtung durchzuführen,

wobei die Vorrichtung ferner eine Reagenztransfereinrichtung umfasst, um die Reagenzien, z.B. Nachweis- und/oder Probenvorbereitungs-Reagenzien, der Probenvorbereitungsvorrichtung oder der Messvorrichtung bereitzustellen. Embodiments create a device in which the handling device is designed to:

• • open a closed sample container, and / or
• • to take the sample or the sample material from the sample container, for example by means of a cannula, a capillary or a smear sampler, and / or
• Perform a sample transfer to the sample preparation device and / or to the measuring device,

wherein the device further comprises a reagent transfer device in order to provide the reagents, for example detection and / or sample preparation reagents, to the sample preparation device or the measuring device.

Embodiments create a device in which the handling device comprises one or more robots.

Embodiments provide an apparatus with a power supply configured to be powered by a power grid and / or by a generator, e.g. a fuel-operated generator, a solar generator, a wind generator or a hydropower generator.

Exemplary embodiments create a device in which the chamber is dimensioned such that the chamber cannot be entered or cannot be walked on by a user or a person.

Exemplary embodiments create a device in which the sample or the sample material contains several substances or biological substances.

Embodiments provide an apparatus in which multiple samples, e.g. on a sample rack, inserted and measured fully automatically.

• 1 zeigt eine schematische Darstellung einer Vorrichtung gemäß einem ersten Ausführungsbeispiel, die zum direkten oder indirekten Nachweis eines oder mehrerer Stoffe in zumindest einer Probe dient,
• 2 zeigt eine Vorrichtung gemäß einem weiteren Ausführungsbeispiel der vorliegenden Erfindung,
• 3 zeigt eine schematische, isometrische Darstellung der Vorrichtung aus 1 oder 2 gemäß einem Ausführungsbeispiel;
• 4 zeigt verschiedene Möglichkeiten, wie ein Benutzer die erfindungsgemäße Vorrichtung tragen kann;
• 5 zeigt ein Ausführungsbeispiel der erfindungsgemäßen Vorrichtung zur Realisierung eines Mini-Biostofflabors gemäß der vorliegenden Erfindung, welches die Schutzmaßnahmen zur Handhabung von Stoffen ermöglicht, die potentiell Biostoffe der Risikostufe 2 enthalten,
• 6 zeigt ein Ausführungsbeispiel der erfindungsgemäßen Vorrichtung zur Realisierung eines Mini-Biostofflabors gemäß der vorliegenden Erfindung, welches die Schutzmaßnahmen zur Handhabung von Stoffen ermöglicht, die potentiell Biostoffe der Risikostufe 3 enthalten,
• 7 zeigt ein Ausführungsbeispiel der erfindungsgemäßen Vorrichtung zur Realisierung eines Mini-Biostofflabors gemäß der vorliegenden Erfindung, welches die Schutzmaßnahmen zur Handhabung von Stoffen ermöglicht, die potentiell Biostoffe der Risikostufe 4 enthalten,
• 8 zeigt eine schematische Darstellung der erfindungsgemäßen Vorrichtung gemäß einem weiteren Ausführungsbeispiel, die zusätzlich eine Probenvorbereitungseinheit aufweist,
• 9 zeigt ein Beispiel eines Probengefäßes, welches das Probenmaterial und verschiedenen Reagenzien getrennt voneinander aufnimmt, und
• 10 zeigt ein Beispiel eines Computersystems zur Realisierung der Steuerung der erfindungsgemäßen Vorrichtung.

Embodiments of the present invention are explained below with reference to the accompanying drawings.

• 1 1 shows a schematic representation of a device according to a first exemplary embodiment, which is used for the direct or indirect detection of one or more substances in at least one sample,
• 2nd shows a device according to a further embodiment of the present invention,
• 3rd shows a schematic, isometric representation of the device 1 or 2nd according to an embodiment;
• 4th shows different ways how a user can wear the device according to the invention;
• 5 shows an embodiment of the device according to the invention for realizing a mini-biological laboratory according to the present invention, which enables the protective measures for handling substances, the potentially biological substances of the risk level 2nd contain,
• 6 shows an embodiment of the device according to the invention for realizing a mini-biological laboratory according to the present invention, which enables the protective measures for handling substances, the potentially biological substances of the risk level 3rd contain,
• 7 shows an embodiment of the device according to the invention for realizing a mini-biological laboratory according to the present invention, which enables the protective measures for handling substances, the potentially biological substances of the risk level 4th contain,
• 8th 2 shows a schematic representation of the device according to the invention in accordance with a further exemplary embodiment, which additionally has a sample preparation unit,
• 9 shows an example of a sample vessel, which receives the sample material and different reagents separately from each other, and
• 10th shows an example of a computer system for realizing the control of the device according to the invention.

In the following description of the exemplary embodiments of the present invention, identical, equivalent or equivalent elements are provided with the same reference symbols.

1 shows a schematic representation of a device according to a first embodiment, which is used for the direct or indirect detection of one or more substances in at least one sample. 1 shows the device 100 that have at least one closed chamber 102 having. The chamber 102 includes at least one lockable access 104 . The chamber 102 is through a floor, for example 106 , Side walls 108 , for example single-walled, double-walled or multi-walled side walls, and by a in 1 lid not shown formed. Inside the chamber 102 there is at least one automatic measuring device M1 for the automatic direct or indirect detection of one or more substances in the at least one sample P that of the device 100 provided. According to exemplary embodiments, one or more further automatic measuring devices M2 be provided as in 1 is indicated by dashed lines. In the chamber 102 there is also an inactivation device I for inactivating biological substances that may be within the sample to be examined P can be included. Inside the chamber 102 is also an automatic handling device R , for example in the form of a robot, for example with one or more grippers 112 arranged. The robot R is provided to the sample P record and sample P or the sample material contained therein to the measuring device M1 to move. The device further comprises 100 a controller S that at the in 1 Embodiment shown on an outer wall of the chamber 102 is arranged and via corresponding control lines S1 to S4 with the lockable access 104 , of the Measuring device M1 , the inactivation device I and the handling device R connected is.

For the direct or indirect detection of one or more substances in the device 100 provided sample P is the controller S effective to the automatic handling device or the robot R to control so that this is the sample P , for example with the gripper 112 , records. According to exemplary embodiments, the control can be provided for this S via the control line S1 the lockable access 104 headed for access 104 , for example to open a hermetically lockable door. One at the entrance 104 provided sample P , for example a sample by a user of the device 104 is held by the gripper 112 of the robot R recorded and inside the chamber 102 emotional. The control S is effective to the lockable access 104 , after placing the sample in the chamber 102 hermetically lock so that after inserting the sample P into the chamber 102 and until the sample is inactivated P access to the chamber 102 is not possible or prevented from the outside. The control S controls the robot R further assuming that the sample P or the sample material contained therein, which is to be examined, to the measuring device M1 is moved. The corresponding control takes place via the control line S4 . The control S controls through the control line S2 the measuring device M1 to perform an analysis of the sample or sample material. After the analysis is complete, the inactivation device I is activated in order to ensure inactivation of any biological substances contained in the sample. The control S effects the activation of the deactivation device via the control line S3 . Depending on the design of the device 100 the inactivation device I causes, for example, the release of suitable agents, such as gases, other fluids or radiation, in the chamber 102 in order to inactivate all biological substances within the chamber. In other configurations, the sample or the sample material can be moved into the inactivation device I and inactivated there.

After deactivation, the control operates S via the control line S1 unlocking access 104 to access the chamber 102 from the outside so that, for example, a user of the device 100 can take the sample from the chamber.

The 2nd shows a device according to a further embodiment of the present invention. Items already based on the 1 have been described in 2nd provided with the same reference numerals and will not be described again. The device according to 2nd differs from the device according to the first embodiment, which is based on the 1 has been described in that the device 100 no automatic measuring devices M1 , M2 has, but instead at least one in the chamber 102 arranged recording A1 which is prepared to accommodate an automatic measuring device. For example, a measuring device such as that shown in FIG 1 was used to enable direct or indirect detection of one or more substances in at least one sample. In other embodiments, one or more additional shots A2 be provided. The receptacles are designed in such a way that different measuring devices or measuring devices or measuring modules that exist, for example, in the prior art can be mechanically accommodated by the receptacle device, the connections required for activation via the line also being provided S2 through the controller S and the necessary connections for the supply of energy are provided. Compared to the device from the first embodiment, the device has 100 according to the second exemplary embodiment, the advantage that, depending on the requirements, it can be equipped with the suitable measuring devices before the user moves it to the place of use.

The functionality of the based on the 2nd shown device is similar to the functionality of the based on the 1 shown device except that the controller S via the control line S2 with one in the shot A1 arranged measuring device can be connected to control it for analysis. Otherwise the control is S with the other elements of the chamber 102 and access 104 over the control lines S1 , S2 and S4 connected to control them in a manner as described above in connection with the 1 has been described. At the in 2nd illustrated embodiment can control S contain various control programs, which are stored, for example, in a memory, depending on the type of measuring device in the recording A1 is placed, the control either automatically recognizes this measuring device, or loads the suitable control program for controlling the measuring device from the memory by specifying the arranged type of measuring device, in order to control the measuring device accordingly when the device is used.

3rd shows a schematic, isometric view of the device 100 out 1 or 2nd according to an embodiment. In 3rd is the device schematically 100 shown the chamber 102 having through the bottom, the side walls and through the in 3rd lid now shown 110 is formed. Within the chamber 102 are, as shown schematically, the automatic measuring device M, the inactivation device I and the handling device R arranged. Access to the interior or to the chamber 102 , for example for taking or taking a sample via the lockable access 104 . Furthermore shows 3rd the control S that, for example, a screen 114 and a keyboard 116 can have. The device 100 is dimensioned so that the chamber 102 is designed only to accommodate the elements described above, the handling of the sample or the sample material taking place automatically within the chamber. The chamber is so dimensioned that it can be used by a user of the device 100 cannot be entered. In other words, the chamber is not accessible. The device 100 can carry handles according to embodiments 118a , 118b have so that the device 100 can be worn by its users.

At this point it should be noted that the devices according to the invention according to the 1 to 3rd are not limited to the configurations shown. Instead of the cuboid configurations, the body of the device 100 which is the chamber 102 involves having any shape. The arrangement of the elements within the chamber can also be freely selected depending on the circumstances, for example the number of devices contained in the chamber, as will be explained in more detail below. The control can also S also be arranged differently.

As mentioned, the device is concerned 100 According to preferred embodiments, a device that can be easily carried by a user, so that it can be brought to the place of use in a simple manner without the logistical effort required in the prior art. Since all analysis steps in the hermetically sealed interior or within the hermetically sealed chamber 102 can be carried out, the device according to the invention can also be used by not specially trained laboratory personnel, in particular for the detection of substances which potentially contain biological substances which can be treated according to the invention, since the protective measure for the inactivation of, for example specified in the BioStoffV, is provided due to the provision of the inactivation device Organic substances is met.

4th shows different ways as a user 120 the device according to the invention 100 can wear, for example in the form of a backpack (see 4 (a) ), or in the form of a suitcase (see 4 (b) ). Alternatively, the device according to the invention can also be equipped with wheels 122 be equipped so that the user 120 the device 100 on the handle 118 can drag along (see 4 (c) ) or can slide in front of you. The device according to the invention can also be provided 100 to move by an unmanned flying object, for example by means of a drone, or the device according to the invention 100 to be designed as a flightable object.

In the following, further exemplary embodiments of the present invention are explained, according to which devices are provided which contain the protective measures according to the BioStoffV for handling substances, which are potentially biological substances of the risk groups 2nd , 3rd and 4th contain, realize. 5 shows an embodiment of the device according to the invention for realizing a mini-biological laboratory according to the present invention, which enables the protective measures for handling substances, the potentially biological substances of the risk level 2nd contain. Compared to 1 In this case, the device according to the invention comprises a disinfection device in addition to the elements already described D , for example, via the control line S5 with the controller S connected is. The disinfection device is used to disinfect the interior of the chamber 102 and the devices arranged therein. The chamber 102 and the devices arranged therein have surfaces which are resistant to the disinfection process used. According to exemplary embodiments, the methods used for disinfection can use various means, for example chemical means, in order to disinfect the interior of the chamber and the arranged devices. In other exemplary embodiments, the means can also include physical means, for example ionizing radiation. In still other embodiments, the disinfection device can use a thermal disinfection method.

The 6 shows an embodiment of the present invention for realizing a device that is able to analyze substances that may contain biological substances belonging to the risk group 3rd are assigned according to BioStoffV. The structure of the device according to 6 is similar to the structure according to 5 , and here is the additional disinfection device already described above D intended. Furthermore, a modified inactivation device I 'is used, which is designed to remove waste arising during the analysis, for example contaminated solid or liquid waste, such as residues of reagents and the like, before removal from the chamber 102 to inactivate. Furthermore, at least the chamber floor 106 designed to be fluid-impermeable to ensure that, for example, during the disinfection process used means, liquid means cannot occur from the interior of the chamber to the outside.

The based on the 6 The embodiment of the device according to the invention shown can not only be used for the analysis of substances, which may be biological substances of the risk group 3rd included, but of course also for the analysis of substances, which may be biological substances of the risk group 2nd can have.

7 shows yet another embodiment of the device according to the invention, which is equipped to enable the analysis of substances that are potentially biological substances of the risk group 4th can contain. The structure is similar to the device according to 6 , in addition to using the 6 described devices within the chamber 102 a ventilation device B and an emergency power supply N is provided. Furthermore, an alternative inactivation device I "is also provided, which, according to this embodiment, is designed as an autoclave or equivalent sterilization device and, in addition to inactivating the sample or the sample material, is also capable of producing contaminated solid or liquid waste and waste water prior to removal the chamber 102 to inactivate. According to 7 is the floor 106 , the lid or the ceiling of the chamber 102 as well as the side walls or inner walls of the chamber 102 designed to be fluid-impermeable, so that the disinfection of the chamber interior is prevented from escaping either by liquid means or by gaseous means.

The ventilation device B is via the control line S6 with the controller S connected and serves in the chamber 102 at least between the time of locking and unlocking access 104 maintain a constant negative pressure. The ventilation device is also designed to supply air into the chamber (→) and to remove air from the chamber (←), using one or more filters F1 , F2 can be provided to filter the supply air and / or the exhaust air. The filters can be designed, for example, as high-performance particulate filters.

The emergency power supply N can also be via a control line S7 with the controller S be connected and serves all elements within the device 100 , especially the control S , in the event of a power failure of the normally provided power supply, which is not shown in the figures, to supply energy in order to take the protective measures for handling substances of the risk group specified in accordance with the Biological Substances Ordinance 4th maintain. The connection of the emergency power supply with the various elements of the device 100 is in 7 schematically through the connections 124 shown that lead from the emergency power supply N to the various devices. According to exemplary embodiments, the emergency power supply comprises a battery or an independently operating generator, e.g. B. a fuel-operated generator, for. B. diesel generator, a solar generator, a wind generator or a hydropower generator.

At the in 7 illustrated embodiment, the access is also designed in the form of a lock, the two mutually lockable doors 104a (Outer door) and 104b (inner door) with a lock chamber in between 104c having.

The based on the 7 The device shown enables the analysis of substances that are potentially biological substances of the risk group 4th include. Of course, the device according to 7 , similar to the device according to 6 The biological substances of the risk group are used to investigate substances 2nd or organic substances of the risk group 3rd include. In these cases, the control can be set such that only the devices necessary to fulfill the present protective measures are activated or controlled.

As mentioned, the devices described above serve for the direct or indirect detection of substances and / or biological substances which are within a sample or within a sample material P which is provided to the device are included. As mentioned, these samples or sample materials can contain substances or biological substances, and the detection that is to be carried out by the measuring device can either be a detection of a substance within the sample or the potentially biological substance-containing sample material, or detection of one or more biological substances within the sample or the sample material .. Substances can, for example, clinico-chemical parameters such as enzymes (eg ALT (GPT), AP (alkaline phosphatase), AP (heat-stable), AST (GOT), cholinesterase, CK (Creatine kinase), GLDH (glutamate dehydrogenase), GPX (glutathione peroxidase), LDH (lactate dehydrogenase), lipase (DGGR), PLI (pancreatic lipase immunoreactivity), TLI test (trypsin-like immunoreactivity), α-amylase, α-HBDH -Hydroxybutyrate dehydrogenase), γ-GT (γ-glutamyl transferase)), substrates (e.g. albumin, bilirubin (total), bilirubin II (direct), cholesterol, cholesterol: high density lipoprotein (HDL), cholesterol: low density ty lipoprotein (LDL), cystatin C, fructosamine, bile acids, total protein, glucose, uric acid, urea, creatinine, lactate, NEFA (non-esterified free fatty acids), SDMA (symmetrical dimethylarginine), taurine, triglycerides, β-HBS (β -Hydroxybutyrate) ), Minerals and electrolytes (e.g. Ca (calcium), Ca (calcium) ionized, Cl (chloride), Co (cobalt), Cu (copper), Fe (iron), K (potassium), Mg (magnesium), Mn ( Manganese), Na (sodium), phosphate inorganic, Se (selenium), Zn (zinc); haematological parameters such as blood count (e.g. small blood count (erythrocytes, leukocytes, hemoglobin and hematocrit), MCHC, MCH, MCV, reticulocytes, thrombocytes)) , Coagulation (e.g. D-dimers, DIC profile, factor IX, factor VIII, factor X, factor XI, factor XII, factor XIII, precallikrein, plasminogen, protein C, protein S, protein Z, fibrinogen, PTT (partial thromboplastin time) , Quick test, thrombin time, thromboelastography, platelet antibody, Von Willebrand antigen), blood group determination (genetic and serological); Urine parameters (e.g. cystine, ornithine, lysine and arginine (COLA test), protein-creatinine ratio (UP / C), amino acids (e.g. Fanconi screening), urine protein electrophoresis, urine sediment, urinary stone analysis, microalbumin, NSBA (fractionated net acid -Base excretion)); immunological parameters (e.g. acetylcholine receptor antibodies, antinuclear antibodies (ANA), C-reactive protein (CRP), Coombs test (direct / indirect), protein electrophoresis, haptoglobin, immunoglobulin A (IgA), immunoglobulin G (IgG, also in newborns) , Immunoglobulin M (IgM), immune status, leukemia profile and classification, rheumatoid factors (Waaler-Rose test), serum amyloid A (SAA), platelet antibody); endocrinological parameters and tumor markers (e.g. 17-OH progesterone, ACTH (adrenocorticotropic hormone), aldosterone, androstenedione, cortisol, cortisol from saliva, erythropoietin, IGF-1 (insulin-like growth factor 1, STH equivalent), insulin, Luteinizing hormone (LH), normetanephrin / metanephrin, oestradiol, estrone sulfate, PAG (Pregnancy Associated Glycoprotein), parathyroid hormone (PTH), parathyroid hormone rP (parathyroid hormone-related protein), PMSG (Pregnant Mare Serum Gonodotropin), pro-BNP Relaxin, serotonin, T3 (total triiodothyronine), T4 (total thyroxine), TSH, testosterone, thyroglobulin antibody, troponin I, TSH (thyroid stimulating hormone), tumor marker AFP (alpha-feto-protein), tumor marker CEA (Carcino- embryonic antigen)); Vitamins (e.g. folic acid, vitamin A, vitamin B1, vitamin B12, vitamin B2, vitamin B6, vitamin D3 (25 OH), vitamin E, β-carotene); Drug levels (eg cyclosporin, digoxin, potassium bromide, phenobarbital, anti-inflammatory drugs, glucocorticoids, NSAIDs, sedatives / tranquilizers, stimulants, tricyclic antidepressants); poisoning substances (e.g. lead, thallium, heavy metals) and other chemical substances (including radioactive substances), elements and compounds.

According to further exemplary embodiments, both the substance and the organic substance can be detected. The proof is not necessarily provided by proof of the organic substance itself or of the substance itself, but this can also be verified indirectly. In the case of organic substances, the indirect detection can, for example, be based on substances formed by the organic substance, e.g. B. virulence factors, metabolites, toxins, enzymes. Direct detection of the organic material can e.g. B. on surface structural proteins, DNA or RNA. When detecting substances, indirect detection can be done, for example, about the product of a reaction. Example: the substance glucose can be converted into δ-D-gluconolactone and H ₂ O ₂ in a reaction catalyzed by glucose oxidase. In a subsequent reaction, H ₂ O ₂ reacts with a colorless, reduced chromogen in a reaction catalyzed by a peroxidase to form H ₂ O and a colored, oxidized chromogen, which can be measured photometrically (the reduced chromogen and the enzymes glucose oxidase and would be in the detection reagent here Peroxidase and possibly contain a reaction buffer). A direct detection of a substance, for example electrolytes, can be done by flame photometry.

As is clear from the above explanation of the exemplary embodiments, the present invention makes it possible to carry out various activities with potentially biofuel-containing material in an automatic manner within a closed interior 102 the device or the system, in accordance with the requirements of the BioStoffV or corresponding other governmental requirements, which is achieved by the provision of the inactivation device for the safe inactivation of organic substances. According to the invention, the possibility is thus created to carry out activities with biofuel-containing material outside of laboratories with corresponding protection level areas, and the system or device according to the invention can be used or set up anywhere outside of a laboratory environment, so that, for example, on site the examinations can be carried out and the problematic sample dispatch described above can thus be dispensed with. For example, immediately after the sample has been taken / obtained, it can be introduced into the system or the device and analyzed without specially trained laboratory personnel, since the requirements of the Biological Substances Ordinance are met due to the inactivation carried out at the end of the process.

The advantage of the procedure according to the invention is explained below on the basis of a microbiological detection of a bacterial infection, a classic procedure being presented first, which, as is readily apparent, is very complex. Subsequently, the use of the device according to the invention is explained in accordance with an embodiment, from which the Advantages according to the invention. For the microbiological detection of a bacterial infection, test material is traditionally or conventionally sent to a clinical microbiological laboratory with the appropriate protection level. The test material is obtained, for example, from a patient with a bacterial infection, e.g. B. by wound smear, urine, nasopharynx smear, bronchial secretion, pleural puncture, cerebrospinal fluid. The pathogen is identified in the clinical microbiological laboratory and an antibiogram (antibiotic sensitivity test) is created. In the laboratory, the bacteria causing the infection are cultivated and propagated from the test material, then isolated to obtain pure cultures and processed and processed using various techniques and processes to identify the species and the strain, and if necessary stored and stored. Before the test material and the cultures grown from it can be fed to the disposal system, an inactivation takes place, e.g. B. by autoclaving. The disadvantage of the procedure described above is that all the tasks described are activities according to the BioStoffV and can therefore only be carried out in a laboratory with a corresponding protection level range in accordance with Annex II BioStoffV, whereby the implementation itself is only permitted by trained specialist personnel.

These disadvantages are avoided by the device according to the invention. The system is self-contained and can be set up anywhere outside of a laboratory environment, so that it is no longer necessary to send samples. Immediately after taking / obtaining the sample, which can be placed in a sample container that already contains all solid and liquid detection reagents and, if necessary, additives for selective pathogen cultivation, the sample container is made available to the system via the access. In addition to the robot, the handling device can, for example, also comprise a sample carriage or, alternatively, the sample carriage by means of which the sample enters the interior of the chamber 102 is introduced. Furthermore, a barcode reader or another identification device can be provided, with an identification assigned to the sample, e.g. B. via a barcode, a program can be selected, which is executed by the control, z. B. for bacterial detection, identification of species, sensitivity testing or screening, z. B. on MRSA. All process steps run automatically within the chamber, without the need for operation by specially trained specialist personnel. For example, if you look at the 7 shown device, it can be used without further ado, since this device ensures, on account of the ventilation device, that the required contamination safety is given, that is to say no biological agents, e.g. B. in the form of contaminated process air, reach the outside, which is made possible, for example, by the use of sterile filters in the ventilation device B. The control is as described above S designed in such a way that the device can no longer be opened after insertion or after the sample has been fitted, so that access is restricted. Using the disinfection device D the disinfectability of the device is ensured, for. B. by fumigation, radiation or chemical disinfection. The inactivation device I, I 'or I "ensures that any biological substances contained in the sample are inactivated, for example by gassing, by radiation, by chemical treatment or by an autoclaving process. The control S is also designed so that the access only after deactivation 104 can be opened again, and the measured sample can be taken and fed to the regular disposal system, for example household waste. The system preferably also includes the necessary emergency power supply N in order to ensure the desired protection level and the operation of the units required for this in the event of a power failure.

According to the invention, a possibility is thus created to also carry out analyzes of substances which can potentially contain biological substances outside of a laboratory environment. Furthermore, an on-site measurement is possible directly after the sample has been taken. Manual sample preparation can be omitted. There is also no need to send samples or transport potentially infectious material. The results of the investigation are available immediately after the conclusion of the investigation, so that compared to conventional approaches, which include shipping and the examination at distant locations, there is a clear time saving until the results are available. The safety and protection of the users of the device is ensured.

The device according to the invention can be used for example in the field of health and medical diagnostics, e.g. B. from the family doctor, in the nursing home, at the veterinarian, in crisis areas, for example an Ebola outbreak region. It can also be used in the environmental field, e.g. B. to examine soil samples or water samples for Legionella or faecal germs. The device according to the invention can also be used in the field of food hygiene, e.g. B. for microbiological analysis of meat products. In the field of animal husbandry, the device according to the invention can, for. B. to detect pathogens in stables. The device according to the invention is also used in the field of hygiene, for example for checking cleaning and Disinfection measures by examining appropriate hygiene samples.

As has already been explained above, the device according to the invention is not limited to certain measuring devices M, rather any suitable measuring devices can be used to implement the device, depending on the substance to be examined. As with the 1 has been explained, the measuring devices can comprise one or more measuring devices which are permanently installed in the device. According to other exemplary embodiments, as can be seen from FIG 2nd was explained, the measuring devices can also be provided interchangeably in order to adapt the device to the substance to be examined. At this point, it should be pointed out that even in the exemplary embodiments which are based on the 5 , 6 and 7 have been described, the measuring devices shown and mentioned therein can be interchangeable, in that instead of the actual measuring device, a suitable receiving unit for receiving different measuring units is provided, which is already completely wired to the control and has the necessary connections for power supply or power supply to the measuring unit, so that by selecting a suitable control program, the control is able to properly control the measuring device used.

The system can, for example, a measuring device for optical reading, z. B. absorption, fluorescence, phosphorescence or for electronic reading. The system or the device can be operated by a user via the control using suitable control and evaluation software. After the sample to be examined has been introduced, the method runs fully automatically according to the programmed measurement protocol. According to embodiments, the system can be equipped with individual detection reagent reservoirs, e.g. B. tanks, or special sample vessels in which the detection reagents, for. B. present in liquid or solid form. The entire process flows, such as B. Reagent addition, incubation, mixing and measuring as well as data evaluation, data storage and data transfer are carried out automatically. After the measurement, all biological substances are inactivated by a suitable method, for example by a disinfectant and method that has been tested and recognized by the Robert Koch Institute. The generated measurement data and results can be evaluated by the control, and the data obtained can be saved and archived. According to exemplary embodiments, provision can be made to connect the system to a network for secure data transmission, and the system as such can be configured, for example, as a loT device. The system can be supplied with power via a conventional power connection, but also via solar energy.

According to the invention, the fully automatic mode of operation of the system minimizes the risk to users from exposure to organic substances, which enables operation by untrained personnel.

As has been explained in connection with the above exemplary embodiments, the device according to the invention enables various activities with potentially biofuel-containing material to be carried out automatically in the interior of the device. According to embodiments, these types of activities also include all types of sample preparation, e.g. B. cell disruption, enrichment, z. B. by filtration or centrifugation, sample transfer steps, in addition to the method for the actual detection (directly or indirectly) of the substances or biological substances from the various sample materials, for. B. from clinical test material, environmental samples, hygiene samples or samples from the field of food analysis. According to the invention, an inactivation is always provided for the safe inactivation of biological material, e.g. B. by thermal or chemical inactivation or inactivation by means of ionizing radiation, UV radiation or steam sterilization. In addition to in vivo methods, e.g. B. in the form of animal experiments, cell culture-based or microbiological-cultural detection methods, molecular biological, immunological, radiological, serological, clinical-chemical and other methods for the potentially infectious test material can also be used. In addition, methods for sensitivity testing of known biological substances on substances such as antibiotics, e.g. B. antibiograms, antivirals, novel agents, chemicals and the like are used. Radioactive substances or ionizing radiation can also be used, in which case additional structural measures for radiation shielding may be provided. Activities with genetically modified organisms can also be carried out.

Some approaches for the detection of biological substances and substances using a device according to the invention are shown below by way of example 7 shown. A first example relates to the molecular biological detection of Ebola, for example from blood samples. In such a scenario, the potentially infectious sample P locked in the lock chamber 104c posed. The system or control then closes and locks the outer door 104a and opens the inner lock door 104b , and the sample container containing the sample is, for example, under Use of the handling device R opens automatically and the sample is transferred to a detection cartridge, for example. Having this inside the hermetically sealed interior 102 there is no risk of infection for the user. In the detection cartridge, for example, all reagents for sample preparation, e.g. B. for cell disruption, for nucleic acid amplification (heating cycles) and detection. The cartridge is the measuring device for automatic measurement according to a measurement protocol, z. B. a fluorescence measurement, and the recorded data are evaluated by the controller and the measurement data are output. Then the cartridge content and the pathogen-containing primary sample, eg. B. the blood test. If the sample material is to be saved, e.g. B. in the case of multiple determination or confirmation of the result by detection with another method, it can alternatively be provided to close the sample vessel again and disinfect it from the outside. You can then use the disinfection device D an indoor disinfection can be performed, e.g. B. the measuring chamber 102 and the lock chamber 104 , together with an external disinfection of the sample vessel before opening the lock. To carry out this method, for example, the measuring device in the form of the GenExpert from Cepheid (http://www.cepheid.com/en/cepheid-solutions/clinical-ivd-tests/critical-infectiousdiseases/xpert-ebola) can be used.

Another example of an application of the device according to the invention is the immunological detection via a lateral flow test, which detects the detection of the Ebola virus antigen VP40 in the test material, e.g. B. allows a serum or a throat swab. Again, the potentially infectious sample P , namely the serum or the throat section, closed in the interior 102 of the system 100 according to 7 introduced over the lock 104 , the system is locked via the control and the sample container is opened automatically, for example by the handling device R by the robot, for example, using its gripper to remove or break through a cover of the sample vessel and to remove the sample material located therein.

Having all this inside the hermetically sealed interior 102 there is no risk of infection for the user. As part of an automatic sample preparation, the sample can be placed in an extraction buffer and then subjected to an incubation with mixing, if necessary with a temperature control. A test cassette is then loaded, and after a period of time determined for the incubation, the result is read from the test cassette, e.g. B. a color change in a chromatographic test. The results are read out and output and the test cassette and the primary sample are deactivated as described above. Alternatively, the sample material can also be picked up and taken up again in the sample vessel, which is then closed again. As already described above, the interior is then disinfected and, if necessary, an external disinfection of the sample vessel. For such a method, the measuring device can according to 7 use the Stada Diagnostik Ebola Rapid lateral flow test (https://www.stada-diagnostik.de/ebola/ebola-schnelltest.html), for example, offered by Stada.

Another example for the use of the device according to the invention 7 is a microbiological-cultural method for the identification and sensitivity testing of bacteria, e.g. B. Yersinia pestis using micro or macro dilution techniques. The sample material to be examined, e.g. B. a blood culture with septicemic course of the infection, is again introduced closed into the system, using the lock according to 7 . The system is locked and the blood culture is incubated to grow bacteria. The material from the blood culture is then automatically processed using the handling device R taken. If necessary, further treatment and cultivation on solid nutrient media, for example selective nutrient media, can be provided fully automatically within the system in order to obtain pure cultures. A bacterial suspension is transferred to cartridges that are equipped with reagents for corresponding detection reactions for biochemical pathogen identification, and after incubation, a measurement is carried out, for example by absorption or fluorescence. The measurement data is then output, for example in the form of a display of the identified pathogens. At the same time, an additional cartridge or a microtiter plate (microdilution process) or a tube (macrodilution process) can be loaded automatically, in which a selection of antibiotics or other chemicals / active substances to be analyzed are present in different concentrations with the bacterial suspension. After incubation, a turbidity measurement is carried out to evaluate and output the measurement data in the form of an antibiogram and identification for the therapy of suitable antibiotics and identification of new active substances. Finally, the bacterial suspension, the sample material, if it should not be available for further analysis, the microtiter plate or the cartridges are inactivated. The interior is then disinfected and the sample vessel disinfected. The Biomerieux, Vitec ID / AST System (https://www.biomerieux.de/klinischediagnostik/vitekr-2-compact) method can be used for such a procedure.

8th shows a schematic representation of the device according to the invention in accordance with a further exemplary embodiment, in which, in addition to those based on 1 described elements a sample preparation unit PV is provided via the control line S8 with the controller S is connected, which prepares the sample before analysis by means of reagents, for example detection and / or sample preparation reagents. The control S is designed to handle the handling device R to drive so that a received sample P before feeding to the measuring device of the sample preparation unit PV is supplied, which is then controlled accordingly to use the appropriate reagents to prepare the samples for measurement. The prepared sample is then transferred from the sample preparation unit PV to the measuring unit M1 using the handling device. According to other exemplary embodiments, the sample preparation unit can also be part of the measuring device and have corresponding containers or cartridges (possibly with reagents already contained) into which the sample material is introduced by the handling device.

At this point, it should be noted that the 8th Sample preparation unit shown also in the case of the 5 , 6 and 7 described devices can be used.

In other exemplary embodiments, no sample preparation unit is required, for example in situations in which the sample vessel itself also has the reagents for the detection reaction and / or for sample preparation in addition to the actual sample or the sample material. For example, the sample material can be provided together with the reagents required for the detection and / or for the preparation by providing a sample vessel which has a plurality of vessels or containers which hold the sample material and the different reagents separately from one another, such as this based on 9 is shown schematically. In this case, no reagent storage within the system, for example within a reservoir thereof, is required; rather, the handling or handling device can R be designed to carry out the sample and reagent transfer from one vessel into another up to the finished measurement solution. After the measurement has been completed, the entire strip with the used remaining reagents can be inactivated, removed and disposed of.

The control described above, as used in the device according to the invention, can be implemented in various ways, for example in hardware using analog and / or digital circuits, in software, by executing instructions by one or more universal or Special processors or as a combination of hardware and software. For example, embodiments of the controller can be implemented in the form of a computer system or other processing system. 10th shows an example of a computer system 200 to implement the control. The computer system 200 includes one or more processors 202 , for example a special or a general digital signal processor. The processor 202 is with a communication infrastructure 204 like a bus or a network. The computer system 200 includes a main memory 206 , for example a random access memory (RAM), and a secondary memory 208 , for example a hard disk drive and / or a removable storage drive. The secondary storage 208 may be the loading of computer programs or other instructions into the computer system 200 enable. The computer system 200 can also be a communication interface 210 included to the transfer of software and data between the computer system 200 and external devices. Communication can take place in electronic, electromagnetic, optical or other signals that can be processed by a communication interface. Communication can be a wire or cable, fiber optics, a telephone line, a cellular phone connection, an RF connection, and other communication channels 212 use.

The above described embodiments are only intended to illustrate the principles of the present invention. It is understood that modifications and variations in the arrangements and the details described herein will be apparent to those skilled in the art. The scope of protection is therefore only limited by the scope of the following claims.

Claims (27)

Device for direct or indirect detection of one or more substances in at least one sample, the device comprising the following features: at least one closed chamber which has at least one lockable access, at least one automatic measuring device arranged in the chamber for automatic direct or indirect detection of one or more substances in the at least one sample, at least one inactivation device for inactivating biological substances arranged in the chamber, at least one automatic handling device arranged in the chamber, which is designed to receive the sample and to move the sample or a sample material to the measuring device, and at least one controller , which is connected to the lockable access, the measuring device, the inactivation device and the handling device, wherein the control is operative to • control the automatic handling device to receive the sample, • the lockable access hermetically locking to prevent external access to the chamber after the sample has been introduced into the chamber and until the sample has been deactivated, • actuating the automatic handling device to move the sample or the sample material to the measuring device, • the measuring device to activate an analysis of the sample or the sample material, • to activate the inactivation device to bring about an inactivation of biological substances, and • to unlock the lockable access after the inactivation to allow external access to the chamber for taking the sample from the Allow chamber. Device, with at least one closed chamber which has at least one lockable access, at least one receptacle arranged in the chamber, which is prepared to receive an automatic measuring device for the automatic direct or indirect detection of one or more substances in at least one sample, at least one inactivation device arranged in the chamber for inactivating biological substances, at least one automatic handling device arranged in the chamber, which is designed to receive the sample or the sample material and to move the sample or the sample material, and at least one controller connected to the lockable access, inactivation device and handling device, the controller being operative to Control the automatic handling device to take up the sample, Hermetically lock the lockable access in order to prevent external access to the chamber after the sample has been introduced into the chamber and until the sample has been inactivated, To control the automatic handling device in order to move the sample or the sample material in the chamber, Triggering the inactivation device in order to inactivate biological substances, and • unlock the lockable access after inactivation to allow external access to the chamber for taking the sample from the chamber, the controller being connectable to a measuring device accommodated in the receptacle in order to control the measuring device in order to analyze the Perform sample or sample material. Device after Claim 1 or 2nd which has one or more of the following features: the device comprises a disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used, the device comprises a ventilation device, which is designed to maintain a constant negative pressure in the chamber, at least between the locking and unlocking of the access, the ventilation device being designed to supply air into the chamber and to remove air from the chamber, and wherein the ventilation device is one or comprises several filters and is designed to guide the supply air and / or the exhaust air through the filter, for example a high-performance suspended matter filter, the device includes an emergency power supply, for example in the form of a battery or an independently operating power generator ts, e.g. a fuel-operated generator, a solar generator, a wind generator or a hydropower generator, the lockable access comprises a lock with interlocking doors, the inactivating device comprises an autoclave or an equivalent sterilization unit, the inactivating device is also designed to contain contaminated solid and liquid Inactivate waste before removal from the chamber, the inactivation device is also designed to inactivate waste water before removal from the chamber, the chamber floor of the chamber is fluid-impermeable, and the chamber inner walls and the chamber ceiling of the chamber are fluid-impermeable. Device after Claim 1 or 2nd , With a disinfection device for disinfecting a chamber interior and the devices arranged therein, wherein the chamber and the devices arranged therein have surfaces which are resistant to the disinfection method used. Device after Claim 4 that has one or more of the following characteristics: the device comprises an emergency power supply, for example in the form of a battery or an independently operating power unit, for example a fuel-operated generator, a solar generator, a wind generator or a hydropower generator, the inactivation device comprises an autoclave or an equivalent sterilization unit, the inactivation device is further designed to inactivate contaminated solid and liquid waste prior to removal from the chamber. Device after Claim 1 or 2nd , comprising: a disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used, the inactivation device being further designed to remove contaminated solid and liquid waste prior to removal to inactivate the chamber, and wherein at least the chamber bottom of the chamber is fluid impermeable. Device after Claim 6 comprising one or more of the following features: the device comprises a ventilation device which is designed to maintain a constant negative pressure in the chamber, at least between the locking and unlocking of the access, the ventilation device being designed to let air into the Supply chamber and to remove air from the chamber, and wherein the ventilation device comprises one or more filters and is designed to guide the supply air and / or the exhaust air through the filter, for example a high-performance suspended matter filter, the device comprises an emergency power supply, for example in the form of a battery or an independently operating power generator, e.g. a fuel-operated generator, a solar generator, a wind generator or a hydropower generator, the lockable access comprises a lock with interlocking doors, the deactivation device comprises an autoclave or an equivalent Sterilization unit, the inactivation device is further configured to inactivate waste water before removal from the chamber. Device after Claim 1 or 2nd , comprising: a disinfection device for disinfecting a chamber interior and the devices arranged therein, the chamber and the devices arranged therein having surfaces which are resistant to the disinfection method used, a ventilation device which is designed to be in the chamber, at least between the locking and unlocking the access to maintain a constant negative pressure, the ventilation device being configured to supply air into and out of the chamber, the ventilation device comprising one or more filters and configured to block the supply air and / or the Exhaust air through the filter, such as a high-performance suspended matter filter, and an emergency power supply, for example in the form of a battery or an independently working power generator, such as a fuel-operated generator, a solar generator, a wind generator or a hydropower plant generator, wherein the lockable access comprises a lock with interlocking doors, wherein the inactivation device comprises an autoclave or an equivalent sterilization unit, wherein the inactivation device is further configured to remove contaminated solid and liquid waste before removal from the chamber and waste water before removal to inactivate the chamber, and wherein the chamber bottom, the chamber inner walls and the chamber ceiling of the chamber are fluid-impermeable. Device according to one of the preceding claims, wherein the inactivation device is designed to inactivate bio-substances thermally, chemically, by means of ionizing radiation, UV radiation or steam sterilization. Device according to one of the preceding claims, in which the control is effective to control the measuring device, so that after the introduction of the one or more samples to be examined, the measuring method runs fully automatically according to a programmed measuring protocol. Device according to one of the preceding claims, in which the control is operative to store the measurement data and results generated by the measuring device for storage or transmission to an external location, e.g. via a wired and / or wireless communication system. Device according to one of the preceding claims, wherein the control comprises a user interface and / or a data interface for connection to a wired and / or wireless communication system. Device according to one of the preceding claims, in which the measuring device uses one or more of the following detection methods: • In vivo methods, for example in the form of animal experiments, or experiments with plants • Cell culture-based or microbiological-cultural detection methods, • Protein chemical, molecular biological, immunological, radiological, serological, cytological, microbiological, parasitological, virulogical, haematological, haemostaseological, endocrinological, histological, clinical-chemical, chemical and physical methods, • Methods to test the sensitivity of biological substances to substances such as antibiotics, eg antibiograms, antimycotics, chemotherapeutics, cytostatics, fungicides, herbicides, antivirals, novel active substances and other chemicals, • Processes using genetically modified organisms, GMOs. Device according to one of the preceding claims, in which the measuring chamber comprises a sample vessel for holding the sample or the sample material and for holding one or more reagents, e.g. Detection and / or sample preparation reagents. Device after Claim 14 , in which the device has one or more reservoirs for the reagents and / or can be equipped with one or more sample vessels in which the reagents are contained, and wherein the control is effective to control the automatic handling device in order to • the measuring device with a Load the sample vessel and / or • insert reagents into the sample vessel of the measuring device. Device according to one of the preceding claims, with a sample preparation device for preparing the sample before the measurement, e.g. by cell disruption, extraction, isolation, enrichment and / or purification by filtration or centrifugation, sample transfer steps. Device after Claim 16 , in which the sample preparation device prepares the sample using one or more reagents, for example detection and / or sample preparation reagents, before being fed to the measuring device, the device having one or more reservoirs for the reagents or detection kits and / or can be equipped with one or more sample vessels in which the reagents, for example in liquid or solid form, are contained, and wherein the control is connected to the sample preparation device and is effective to • control the automatic handling device to move the sample to the sample preparation device , • Activate the sample preparation device to treat the sample or the sample material with one or more of the reagents or to transfer the sample or the sample material into a sample vessel, • Activate the automatic handling device to the sample or the sample material or the sample vessel to the measuring device to move. Device according to one of the preceding claims, in which the at least one sample is provided in a sample container, the automatic handling device being designed to receive the sample container, to take the sample or the sample material from the sample container, and the sample or the sample material to the Measuring device and / or to move to the sample preparation device. Device according to one of the preceding claims, in which the at least one sample is provided in a sample container, the sample container containing one or more reagents, e.g. Detection and / or sample preparation reagents, contains wherein the automatic handling device is designed to to take the sample container, to treat or prepare the sample or the sample material with reagents from the sample container, and to move the treated or prepared sample or the sample material to the measuring device. Device after Claim 18 or 19th , in which the sample container is closed, for example with a septum, the automatic handling device being designed to open the sample container. Device according to one of the preceding claims, in which the handling device is designed to: - open a closed sample container and / or - remove the sample or the sample material from the sample container, for example by means of a cannula, a capillary or a smear sampler, and / or - carry out a sample transfer to the sample preparation device and / or to the measuring device, and / or - provide reagents, eg detection and / or sample preparation reagents. Device according to one of the Claims 1 to 20th , in which the handling device is designed to: - open a closed sample container, and / or - remove the sample or the sample material from the sample container, for example by means of a cannula, a capillary or a swab specimen collector, and / or - a sample transfer to the sample preparation device and / or to the measuring device, the device further comprising a reagent transfer device in order to provide the reagents, for example detection and / or sample preparation reagents, to the sample preparation device or the measuring device. Device according to one of the preceding claims, wherein the handling device comprises one or more robots. Device according to one of the preceding claims, with a power supply which is designed to be operated by a power network and / or by a power generator, e.g. a fuel-operated generator, a solar generator, a wind generator or a hydropower generator. Device according to one of the preceding claims, in which the chamber is dimensioned such that the chamber cannot be entered or cannot be walked on by a user or a person. Device according to one of the preceding claims, wherein the sample or the sample material contains several substances or biological substances. Device according to one of the preceding claims, in which several samples, e.g. on a sample rack, inserted and measured fully automatically.

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