WO2013001102A1

WO2013001102A1 - System for detecting commonly abused drugs

Info

Publication number: WO2013001102A1
Application number: PCT/ES2011/000213
Authority: WO
Inventors: Valentin BALLESTEROS AGUADO
Original assignee: V.P. Pharma Baru, S.L.
Priority date: 2011-06-27
Filing date: 2011-06-27
Publication date: 2013-01-03
Also published as: ES2523682A1; ES2523682B1

Abstract

The invention relates to a system that makes it possible to detect the presence of commonly abused substances in a saliva sample taken from the driver of a motor vehicle, with simultaneous identification of the commonly abused substance should the result be positive. The system is based on reactive strips that have a surface divided into a part for saliva absorption, a part for diagnosis and control with bands of reagent in order to determine a positive or negative result, and a part with bands of reactive material in order to identify the substance. The system is embodied by a kit that includes a tubular saliva collection chamber, having a circular or rectangular cross-section, a support with the reactive strips and a collecting cover having a support rod on the opposite end of which is a sponge to be moistened with the saliva of the test subject.

Description

"SYSTEM FOR THE DETECTION OF ABUSE DRUGS"

DESCRIPTION

Object of the Invention

The present invention relates to a system for the detection of drugs of abuse, which provides essential characteristics of novelty and remarkable advantages with respect to the means known and used for the same purposes in the current state of the art.

More particularly, the invention develops a system for the detection of drugs of abuse by performing a quick and simple test carried out based on a sample of saliva from the researched person, and with the help of control strips that comply with the dual objective of providing accurate qualitative information on the presence or absence of toxic substances, and, where appropriate, the specific type of drug consumed, without risk of errors in terms of identification of the substance.

The field of application of the invention is comprised mainly within the industrial sector dedicated to the manufacture and / or commercialization of systems specifically designed for the detection and evaluation of drug consumption.

Background and Summary of the Invention

The high number of fatal accidents that occur every year on roads around the world associated with the consumption of alcohol or other types of drugs is generally known to everyone. For several decades, administrations in a large number of countries have articulated various means to try to stop a situation that grows every day, with increasingly harmful and worrisome results. In this sense, the use of motor vehicles after having ingested some type of drug, constitutes a confluence of risks with catastrophic results given the high number of deaths that occur each year on roads around the world.

The aforementioned situation has led to the need to carry out frequent checks on the operational capacity of people performing vehicle driving tasks, given the danger that an abusive consumption of any type of drug by a driver of a vehicle may pose. by motor, and for this the traffic police has been equipped with control kits for blood alcohol tests and detection of other types of drugs.

The systems currently known for the detection of a drug consumption above a pre-established level, which could negatively affect the control capacity of a motor vehicle, is normally based on the taking of samples of saliva or urine, being the first more frequent than the second. In any case, the quantitative determination of substances of abuse can only be carried out at present with the use of the gas and mass spectrography technique. However, in terms of traffic surveillance, quantitative studies can not be carried out due to the complexity and fragility of this type of machines that prevent them from being used in any situation, and also due to the need for tests are carried out by technical personnel in toxicology laboratories. For this reason, only qualitative tests aimed at detect the presence or not of a substance in a saliva sample taken from the driver of the vehicle, and if the detection is positive, the results can be checked later by gas and mass spectrophotometry.

The saliva drug detection systems currently in use suffer from a number of use problems in practice, some of which are mentioned below:

- Two samples of saliva are needed: the first sample should be placed in a container from which a part of that saliva is placed in the detection device. If the preliminary result is positive, a second sample must be obtained to be sent to the laboratory, with the added disadvantage that this second sample is not the same as the first one, which can lead to erroneous conclusions;

- The manipulation also constitutes a problem: the samples must be handled by the traffic agent, who must take charge of the sampling of saliva, its placement in the detection device and later in the reading machine;

- On the other hand, there is a problem of dilution: the sample that is sent to the laboratory is diluted by the agent at the time of intake, so there may be dilution errors that lead to a negative result. On the contrary, if you try to raise the cut level, that is, the lower limit of detection, this system would be invalid because it can not guarantee a precise dilution;

- Another problem is the time to obtain the results: the system that takes the sample directly in the device, takes a time of order of 20 - 25 minutes to provide the result; - Finally, there is also a problem associated with the machine itself: it can not be taken out of the vehicle of documents or from the office.

The drug abuse detectors currently marketed under the denomination Drager DrugTest 5000 ™, allow rapid and reliable detection on six different substance categories in a simultaneous manner in a few minutes. The system can be used stationary or portable, thus adapting to a large number of applications. The system comprises a test kit and an analyzer, and uses a saliva sample to determine the possible existence of drugs such as opiates, cocaine, cannabis, amphetamines, designer drugs and tranquilizers of the benzodiazepine group. The system is very sensitive and can detect even small traces of drugs in oral fluids. The interference with other substances is practically nil, and in addition, the efficiency of the system is very high given that, if the results obtained with it are compared with the results obtained in the laboratory, the system's reliability exceeds 95%. In addition, because it is a portable system, it can be used in traffic controls, penal institutions, and also, if used on a stationary basis, it is especially useful for use in occupational medicine, industrial safety, clinics, or rehabilitation facilities. of drug addicts.

The use of the Drager ™ system is also very simple. Once the protection cap of the saliva collector is removed, the probante places the collector in its mouth. When the amount of saliva collected is sufficient for the analysis, an indicator built into the collector It will adopt a blue coloration, with which the person in charge of carrying out the test enters the collector in the analyzer and, after a few minutes, all the groups of substances detected appear on the analyzer screen.

Therefore, it is a much more discreet and hygienic process, both for the probante and for the person in charge of performing the test, than other alternative procedures, such as urine sampling. It is therefore a non-invasive test, hygienic in use since it avoids contact with the sample and its components, and in addition, the continuous observation of the sampling effectively reduces any possible manipulation by the probante. The analyzer is capable of storing the number, progression and results of up to 500 tests. The errors of the user and the equipment are also recorded and documented for later reading, and additionally incorporates an infrared interface for connection with a portable printer that allows printing the results immediately, if necessary.

Another test is also known in the market for the detection of substances of abuse in a saliva sample, marketed under the name Cozart ™. This test includes a swab for taking the saliva sample by inserting it into the mouth of the probante, a disposable plate for the evaluation of the drug test, and an analyzer device that interprets and digitally samples the results, with the capacity to store them. for future references. The Cozart ™ test brings together important advantages such as:

- Simple and non-invasive sample taking;

- Shows that it can be observed at all times, thus reducing the possibilities of adulteration of it;

- Results in a few minutes against the need to invest hours, or even days, to obtain a result in a laboratory;

- Possibility of detecting up to 5 different drugs in a single sample (cannabinoids, amphetamines, cocaine, opiates and benzodiazepines).

Although the known systems fulfill the functions for which they have been developed, the result of all this is that the samples have to undergo a certain manipulation, and also, when a sample is sent to the laboratory, it is not the same sample on which the first analysis was performed.

It must also be borne in mind that in the case of using the first mentioned system, a reading machine should be used that needs an approximate time of about 15 minutes for each of the tests carried out, which constitutes a major difficulty at the time of writing. to perform several tests at the time of an accident: four tests would imply the need to invest one hour, six tests would take an hour and a half, etc., with the particularity that if the result of those tests is negative, agents of traffic to be accused of illegal detention with the inconveniences that all this could cause. In the case of the second mentioned system, something similar happens since only one test can be carried out each time, and each test carried out requires a time of at least 5 to 10 minutes.

It is also known in the current state of the art the existence of some test strips that allow to determine if the proponent has or has not used substances of abuse, and which have been those substances in his case. In this case it is a set of strips, necessarily arranged in a certain order according to the sequence of substances on which the test is performed, whose order must be maintained since the reader can not distinguish between one strip and another, with the disadvantage that the positional variation of the strips would cause an absolutely differentiated and erroneous interpretation of the results on the identification of the various substances. To perform the test to a driver of a vehicle, the device is delivered inside a protective container, and once opened it extracts a sponge that it enters in its mouth to soak it in saliva, after which it introduces again the sponge inside the device and pressing it causes the expulsion of saliva from the sponge, which is absorbed by the test strips to produce the antigen-antibody reaction. The appearance of a colored line in the lower part of a test zone of the strip indicates a negative result, whereas if no line appears, the result is positive.

Now, since the result in itself does not allow to distinguish the types of drugs, a system of colors has been developed that allows identifying the strips and thus being able to know which drug they are referring to. The system guarantees high precision given the reliability of manufacturing processes to avoid errors.

However, in practice, the use of the system has some drawbacks regarding the interpretation and impression of the result: if there is not enough lighting at the test site or the visual acuity of the agent is not due, it may occur that the colors are not well distinguished and therefore errors can occur regarding the interpretation of the result on the drug to which it corresponds. Additionally, the use of a photograph is only valid if it is done in color, and finally, if the strips are inserted in a reading machine, they must always be arranged in the same order.

There is, therefore, a need in the current state of the art for a system that can be applied in the realization of tests on the consumption of substances of abuse, that provides reliable simultaneous results on the existence of such consumption and on the nature of the substances consumed. This is the objective that the present invention has been proposed, and that has been fully achieved by the system that will be described in the following.

In essence, the system proposed by the invention is based on taking a sample of saliva from the probante, performed in such a way that manipulation of said sample by the proban is avoided since the result is obtained directly from the saliva accumulated in the a sample taking sponge, and it is that same sample that can be sent to the laboratory for verification. The system uses a series of test test strips specifically designed for the detection of a multiplicity of substances, for whose identification operation said strips present their surface divided into three portions, namely, a first portion of saliva absorption, an intermediate portion constitutive of the test and control area, and a third identification portion of the substance consumed in which several bands or transversal control lines obtained by means of reagents or by their addition by ink during the manufacturing process of the strip. The introduction into the reading machine, is done with the help of a tray that facilitates the correct placement of the strips so that the reader passes over them and can read them always in the same position, avoiding any possibility of error.

Brief Description of the Drawings

These and other features and advantages of the invention will be more clearly apparent from the following detailed description of a preferred embodiment thereof, given solely by way of illustration and not limitation, with reference to the accompanying drawings. , in which:

Figure 1 is a schematic illustrative representation of a plan view of a test strip of the type used by the drug abuse detection system of the present invention;

Figure 2 is a representation of pairs of strips of Figure 1 (a-b; c-d; e-f), illustrating an application example of the system of the invention, and

Figure 3 is a schematic, perspective view, illustrative of an exemplary embodiment of a presentation kit of the system of the invention.

Description of a Preferred Embodiment

As mentioned above, the detailed description of the preferred embodiment of the object of the invention will be carried out in the following with the help of the attached drawings, through which they use the same numerical references to designate equal or equivalent parts. Thus, attending in the first place to the representation of the Figure 1 of the drawings, there is shown a schematic representation of a plan view of a test strip of the type used by the system of the present invention. According to said representation, the test strip is identified in general by the reference number 1, adopts configuration of substantially flattened body, thin, elongated rectangular plant, ie with a longitudinal dimension much greater than the transversal, and its surface is divided into three consecutive portions, delimited by means of separation lines, of which a first portion is the absorption zone of the saliva of the sample taken from the driver; the intermediate Ib portion, of somewhat longer length than the previous one, constitutes the diagnostic and control area, and the last portion of it, of length significantly greater than the previous ones, constitutes the identification zone.

As can be seen in the aforementioned Figure 1, the intermediate control diagnostic zone Ib and the identification area include, respectively, two and four transverse bands or bands, indicated respectively by the reference numbers 2 and 3, which constitute the bands of reagents necessary both for the determination of the existence of substance abuse, and the type of substance consumed.

For this, when the saliva absorbed by the zone the absorption migrates and ascends by the strip 1 until reaching the position of the bands 2, 3 of said strip, the behavior associated to said bands allows to determine easily and immediately the presence of drugs in the saliva sample, if the concentration of the drug exceeds a pre-established minimum level. According to a preferred embodiment, when a test on a sample of saliva lacking in drugs, or the drug level of said sample is lower than the pre-established limit, both bands 2 of the diagnosis and control area Ib appear clearly. If, on the contrary, the saliva sample contains a concentration of substance of abuse higher than said pre-established limit, only a predetermined one of the bands 2 will be shown in an evident manner, without the other band 2 being visible; the rise of the saliva by capillarity to the position of the transversal strips 3 will determine which of these bands will be shown clearly, depending on which drug is contained in the saliva sample.

Figure 2 shows an exemplary embodiment illustrating a system designed according to the invention for the detection in the saliva sample analyzed of, for example, cocaine, opiates and marijuana. According to the example mentioned, the pair of representations (a) and (b) indicate the two possibilities that can be observed in a saliva sample, namely, a first condition (a) in which no cocaine is present (or at least, sufficient amount above the preset minimum level), in which case both transverse strips or bands 2 of the control zone are clearly shown, and also the four strips 3 of the zone identify the strip reactive, and a second condition (b) in which the presence of cocaine has been detected, in which case there appears in the Ib portion of diagnosis and control only a transverse band 2 indicative of the positive result, together with the bands 3 of the portion the indications of cocaine as the drug under test; in the case of the pair of representations (c) and (d), this is a situation similar to the one mentioned, but dedicated to the detection of opiates, so that the representation (c) with both transverse stripes 2 evident shows the condition of drug deficiency (or at least above the pre-established minimum level), while the representation (d) with a single transverse band 2 shows the positive result, with the stripes 3 evident in the positions corresponding to the investigated drug; finally, the representations (e) and (f) are illustrative of a test similar to the previous ones, but intended in this case to detect the presence of marijuana, so that in representation (e) it is considered absence of drug (or presence by below the pre-established limit) before the evidence of both transversal strips 2, and in the representation (f) the presence of marijuana is considered above the pre-established level by virtue of the positive result indicated by the presence of the single strip 2 and the position of the 3 stripes in the area will identify you.

As will be understood, the description of Figure 2 must be interpreted, as has been said, as a mere illustrative example and in no case limiting, being able to be altered both the number of stripes and the positions in which they become evident depending on of the type of substances with respect to which the analysis is carried out.

As will be understood, the assembly comprised by the drug abuse detection system according to the invention is provided to a proponent under conditions of absolute protection and sterility / hygiene. For this, the assembly has been realized in the form of a portable kit, which is supplied inside a suitable container, and which is composed of the elements shown in Figure 3: a collecting chamber 4, consisting of a tubular body , circular or rectangular section, opened by one of its bases and intended to receive inside the saliva sample, which in an intermediate position presents a transparent portion that allows to see its interior, hidden by a removable label 9 during the use of said collecting chamber in the performance of a detection test, and also provided in lower positions of windows 10 around it, at a height equivalent to the position of the intermediate portions Ib of the test strips 1, to allow observation of said diagnostic and control portions Ib when the test strips 1 they are housed inside the collecting chamber 4; a support 5 carrying the various test strips, constituted by a ring from which the aforementioned test strips 1 are suspended, prepared for checking the different substances to which the test refers, the diameter of the support being such that it can be introduced, in a removable manner, inside said collecting chamber 4; and a collecting cap, identified with the reference numeral 6, which has a threaded area for coupling with said collecting chamber 4, and from which a carrier rod 7 hangs at its opposite end from a sponge 8 prepared to be introduced in the mouth of the probante and be soaked with the saliva of the latter.

At this point of the description it should be clarified that the mention of a tubular collecting chamber 4 corresponds only to a preferred embodiment of the invention and should not be interpreted, in any way, with a limiting character, since, as may result obvious to a person skilled in the art, said collecting chamber can adopt a flat configuration, rectangular cross-section, in which case the presentation of the set of strips 1 also flattened, joined successively to each other by a corresponding one of its respective ends by means of a support configured as a longitudinal strip, without thereby altering any of the principles inherent in the system of the present invention.

The performance of the test for detecting substances of abuse with the aid of the kit corresponding to the system of the invention is extremely easy and quick to carry out. For this, once the assembly of Figure 3 is removed from the interior of its protective container (not shown), the lid 6 is unscrewed and the probante is provided so that the latter can insert the sponge 8 in its mouth and soak it with saliva. Once soaked and after extraction of the support 5 with the associated test strips 1, the sponge is introduced inside the collecting chamber 4 and after a sufficient pressure to motivate the release of the saliva from the sponge to the interior of the the chamber, then proceeds to insert the holder 5 with the test strips inside the collector chamber 4. After a few minutes have elapsed corresponding to the time of the test, the label 9 is removed, exposing the transparent area of the body of the collecting chamber 4 and allowing it to be seen through it which are the transversal strips or bands 3 that are evident, in case of existence of substance of abuse in the sample of saliva analyzed. The windows 10 allow to determine previously whether the results are positive or negative, depending on whether a single of the strips 2 is evident or if both strips are evident. The identification of the patient can be written on the surface of the collection chamber 4 itself, avoiding possible errors, and also, in case that the amount of each substance of abuse contained in the analyzed sample must be determined quantitatively, the same collector chamber 4 is sent to the laboratory, without any manipulation.

As will be understood, the system proposed by the invention guarantees an adequate management of the operations intended to detect the possible consumption of substances of abuse by a driver of a motor vehicle, without the need for manipulations of the sample by the agent in charge of the taking of the same, and without need of a second sample for the quantitative determination of the substance in the sample analyzed.

It is not considered necessary to broaden the content of the present description so that a person skilled in the art can understand its scope and the advantages derived therefrom, as well as carry out the practical realization of its object.

Notwithstanding the foregoing, and since the described description corresponds only with a preferred embodiment, it will be understood that within its essential nature multiple modifications and variations of detail may be introduced, also included within the scope of the invention, and that in particular may be affecting features such as the shape, size or materials of manufacture, or any others that do not alter the invention as described and as defined in the claims that follow.

Claims

1.- System for the detection of drugs of abuse, specially designed for the determination of a condition of consumption of substances of abuse by a driver of a motor vehicle, in an amount exceeding a pre-established minimum limit, whose detection is performed on the basis of a sample of saliva taken to the driver of the vehicle for analysis by application of a set of test strips (1), characterized in that each of said test strips is configured as a substantially flat rectangular body, of reduced thickness, whose surface appears divided according to the longitudinal direction of the strip in a first portion (1) of saliva absorption; an intermediate portion (Ib) of diagnosis and control, and a last identification portion (le), wherein said intermediate portion (Ib) and said identification portion (le) include respective transverse bands or bands (2, 3) of reactive material or ink.

2. System according to claim 1, characterized in that the intermediate portion (Ib) of diagnosis and control of the test strip (1) includes two bands or transverse stripes (2).

3. System according to claim 1, characterized in that the identification portion (le) of the reactive strip (1) includes at least four bands or transverse stripes (3).

4. System according to one or more of the preceding claims, characterized in that both bands or transverse stripes (2) of the diagnostic portion (Ib) and control become evident when they are reached by the saliva of a prob- lent absorbed by the portion (la) of the reactive strip (1) and the saliva lacks substance of abuse or contains it in a concentration below a pre-established minimum limit.

5. System according to one or more of the preceding claims, characterized in that only one of the transverse bands or bands (2) of the intermediate portion (Ib) of the test strip (1) becomes evident when it is reached by a saliva from of the absorption portion containing a concentration of substance of abuse above the pre-established minimum level.

6. System according to one or more of the preceding claims, characterized in that the transverse bands or bands (3) included in the identification portion (le) of the test strip are evident in variable positions depending on the substance of abuse detected in the saliva of the patient or previously painted in ink.

7. System according to claims 1 to 6, characterized in that it is materialized by means of a kit, included inside a sterile bag, comprising a chamber (4) collecting saliva of the probante, of a general tubular shape, of circular section or rectangular, open by one of its bases; a support (5) from which hang the reactive strips (1) used to carry out the test, sized to be housed inside said collecting chamber (4), and a collecting cover (6), capable of threaded coupling to the base open of said collecting chamber (4).

8. System according to claim 7, characterized because said collecting cap (6) includes a rod that at its opposite end carries a sponge (8) intended to be soaked with saliva prior introduction into the mouth of the probante.

9. - System according to claim 7, characterized in that said collection chamber (4) includes a transparent body portion in intermediate position, hidden by a removable label (9), as well as the formation of windows (10) at an equivalent height to the position of the intermediate portions (Ib) of the test strips (1) when they are introduced into said collection chamber (4).

10. - System according to one or more of claims 7 to 9, characterized in that the collection chamber (4) in turn constitutes a container for the eventual sending, where appropriate, of the same sample of saliva taken to the probante to the laboratory in charge of the quantitative analysis of it.