JP2003526789A - Collection system for storing and manipulating samples - Google Patents

Abstract

(57) Abstract: The present invention relates to a cartridge for containing a sample, the cartridge comprising a housing, a lid capable of sealing the housing, and indicating to a user whether the lid has been removed from the housing. A tamper evident system coupled to the cartridge that allows a user to determine if the sample may be contaminated. The present invention also provides a sample-holding means provided within the housing and a sample-handling device for automatically inserting a sample into the sample-holding means and removing the sample from the sample-holding means, and controlling the sample-handling device. An apparatus for storing a sample comprising a user interface coupled to a control unit.

Description

Detailed Description of the Invention

[0001] BACKGROUND OF THE INVENTION (a) Field of the Invention The present invention, contamination, degradation, or low risk of biohazard concerns tamperproof sample recovery system for a possible operation of automation.

(B) Description of the Prior Art Obtaining biological samples from the body for further analysis such as DNA testing is well known in the art. These samples are typically placed on a substrate to facilitate transport and handling.

One well-known substrate is nitrocellulose paper, which must be dried in air when biological materials (such as blood, saliva, etc.) are applied to it. The substrate is typically not hermetic and is placed in or on a container that forms a device that is not well protected from moisture, contamination, UV, degradation, etc. These devices are also problematic because it is difficult to automate the method of using such types of devices. More specifically, these instruments are labor intensive and require careful manipulation before analyzing the samples contained therein.

Also, after applying the biological sample to the paper, it is usually dried in the atmosphere for about 30 minutes before storage. Such samples can become contaminated during drying. They may be quickly stored in plastic bags containing desiccant, but this is not a convenient way to handle biological samples and is not suitable for automation of the method.

Other substrates are used in Petri dishes for other biological methods. These substrates are also susceptible to contamination. Petri dishes are also difficult to automate.

Another problem with genetic material is the security during storage of genetic material samples used in, for example, forensic DNA analysis and biopharmaceutical studies. There is a major problem preventing tampering and misuse of this material.

[0007] Since the genetic material contains the personal information of the individual and problems with genetic tests can be important (for example, criminal tests or DNA tests in medical diagnosis), preservation of samples should be strictly secured. It must be. In fact, the actual security system does not prevent access to the sample, and no record is left even if the sample is accessed. The test results are also unprotected.

It is also well known in the art to manually sample a portion of a biological sample for testing. Biological samples are not optimally used in this method. Also, it is not possible for the technician to recognize the sample based on the shape and where it was emptied in the previous sampling. Being able to recognize the sample in such a way is only a supplement to the security level in the operation of the sample. The use of automated systems can also reduce human intervention and reduce the risk of human error, contamination, and biohazard. Although some automatic sampling systems do exist, they always sample at the same location and cannot use large numbers of samples.

Therefore, there is a need to design an automatic biological sample collection system that allows for automated manipulation, safe storage, and automatic sampling of biological samples.

It would be highly desirable to provide a tamper proof biological sample collection system for potentially automated operations with low risk of contamination, degradation, or biohazard.

[0011] SUMMARY An object of the present invention relates to a pollution, degradation, or low risk of biohazard is to provide a tamper-evident biological sample recovery system for possible manipulation of automation.

In accordance with the present invention, a housing, a lid capable of sealing the housing, and indicating to the user whether the lid has been removed from the housing may indicate that the sample may have been contaminated, replaced, or tampered with. A cartridge for containing a sample is provided that comprises a tamper-evident system coupled to the cartridge that allows a user to determine if there is.

In the cartridge according to a preferred embodiment of the present invention, the tamper evident system has a first position that indicates to the user that the cartridge is not in use and a second position that indicates to the user that the cartridge is sealed. And a movable indicator at a third position to indicate to the user that the cartridge has been opened.

In the cartridge according to the preferred embodiment of the present invention, the tamper evident system is coupled to the lid.

In a cartridge according to a preferred aspect of the present invention, the lid comprises a sample substrate bonded thereto.

[0016]   In the cartridge according to the preferred embodiment of the present invention, the sample is a biological sample.

In the cartridge according to the preferred embodiment of the present invention, the tamper evident system comprises a first and second stowage position for accommodating a stopper that maintains the indicator in a first unsealed position or a second closed position. And a first engaging means for engaging the first and second storage positions to move the indicator from the first open position to the second closed position and the third open position. And a component.

In the cartridge according to a preferred aspect of the present invention, the tamper evident system further comprises means for locking the present cartridge.

In a cartridge according to a preferred aspect of the present invention, a stopper is coupled to a component, the component further comprising a second engagement means for engaging a corresponding receiving means provided on the housing, whereby Seal the housing.

[0020]   The cartridge according to the preferred embodiment of the present invention further comprises a desiccant.

According to the present invention, a housing, a sample storage means provided in the housing, a sample handling device for automatically inserting a sample into the sample storage means and taking out a sample from the sample storage means, and a sample handling device An apparatus for storing a sample is provided, comprising a user interface coupled to the control unit for controlling the.

In a device according to a preferred embodiment of the invention, the sample may be contaminated by the housing, a lid capable of sealing the housing, and indicating to the user whether the lid has been removed from the housing. And a tamper evident system coupled to the cartridge that allows the user to determine if there is any.

In the device according to a preferred embodiment of the invention, the control unit comprises a sample insertion and / or
Or, it has a database that records each time it is taken out.

[0024]   In a device according to a preferred aspect of the present invention, the sample handling device comprises   A carrier device mounted movably in the housing,   An arm coupled to the carrier,   And a grip connected to the arm for gripping the sample.

In a device according to a preferred embodiment of the invention, the sample is contained in a cartridge with a barcode and / or RF tag and the grip comprises a barcode and / or RF scanner.

[0026]   In the device according to the preferred embodiment of the invention, the sample is a biological sample.

According to the present invention, a CPU and a CPU for scanning the sample and identifying the optimum position for sampling the sample.
An apparatus for automatically sampling a sample is provided, comprising a camera coupled to and a sampling device for sampling the sample at an optimal position.

In a device according to a preferred embodiment of the invention, the sample is contained in a cartridge with a barcode and / or an RF tag and the grip comprises a barcode and / or an RF scanner.

[0029]   In the device according to the preferred embodiment of the invention, the sample is a biological sample.

In a device according to a preferred embodiment of the invention, means for comparing the visual signature of the sample with the visual signature previously recorded in the database, the database being provided in the housing and in the housing. A sample interface, a sample handling device for automatically inserting and removing the sample from the sample receiving device, and a user interface coupled to a control unit with a database for controlling the sample handling device And a storage unit, which comprises:

[0031]   For purposes of the present invention, the following terms are defined below.

The term “biological sample” is intended to mean a fluid sample such as blood, saliva, urine, and sperm, and a non-fluid sample such as hair, nails, tissue, and skin.

The term “sample” refers to all biological samples as defined above as well as air sensitive materials,
It is intended to mean light-sensitive materials, vaccines, pharmaceutical products, microbiological products and blood or cell products.

The term “sample substrate” is intended to mean a nitrocellulose absorbent membrane, agarose gel used in Petri dishes, glass lamellas used in microscopy.

The term “treatment” is intended to mean the placement, removal or relocation of a sample to a storage unit, sampling of a sample, or modification of a visual signature.

The term “visual signature” is intended to mean the quantification of sample morphology, including the location of the sample previously taken. The visual signature is unique to the sample.

In describing the nature of the present invention in general, reference will be made to the accompanying drawings, which are shown by way of illustration herein and preferred embodiments thereof.

[0038] According to The invention relates, are provided tamper-evident biological sample collection cartridge. Figure 1
Is an absorbent membrane (1) to which a biological sample (such as but not limited to blood) is to be applied, a desiccant (2), a desiccant retention device (3), two seals ( 4), a preferred construction of a cartridge device according to the invention with a fixed rear cover (5) and a sliding front cover (6) is shown. The notch on the side of the cartridge facilitates handling of the cartridge in the automatic operating method. These notches allow the device to be grabbed by an automated mechanism such as a robot arm.
The flat surface can have a bar code (7) applied to it to index further storage.

FIG. 2 illustrates a cross-sectional view of one preferred configuration of cartridge device. that is,
Incorporates a desiccant (1) that absorbs sample moisture, an absorbent membrane (2) that applies biological samples, and a puncture-resistant, non-absorbent support that facilitates puncture and recovery of a portion of the absorbent membrane. . The figure also shows a desiccant holding device (3), two seals (4), a back cover (5) and a sliding front cover (6).

Depending on the application of the cartridge device, the absorbent membrane may be replaced with another sample substrate such as agarose gel and glass sheet. If the cartridge is used for non-fluidic biological samples such as hair, the cartridge device may not have a sample substrate.
If the sample substrate is nitrocellulose paper or another type of sample substrate that requires drying, the instrument comprises a desiccant retention device and a silica gel desiccant.

The cartridge device preferably comprises means for sealing the cartridge. Such a seal protects the sample from contamination with other biological materials that can mislead the test results. The device also preferably comprises a locking device that allows the unlocking device to be unlocked only by the owner of the experiment.

The cartridge device preferably comprises a tamper evident indicator. 3A-C are front views of a tamper evident lock and indicator mechanism. The first figure shows the tamper evident mechanism when the cartridge is opened. At this point, the wheel (1)
Is maintained in the first unsealed position, where the indicator window on the back cover shows blue. Blue means the cartridge has not yet been used. The tamper evident mechanism is for engaging and maintaining the wheel in three distinct positions, a first open position, a second closed position and a third position indicating that the device has been opened at least once. It comprises an engaging means (2) and a stopper (3), the third position of which cannot be changed once it reaches this position.

FIG. 2 shows the tamper evident mechanism when the cartridge is first closed. At this point, the engagement means is engaged in the first stowage position (4) of the wheel for moving the wheel from the first opening to the second closed position, and the stopper positions the wheel in that position. To maintain. The display shows green on the display window provided on the back cover. Green indicates that the cartridge has not been opened.

FIG. 3 shows an unauthorized opening prevention mechanism when the cartridge is opened. At this point, the engagement means is engaged in the second storage position (5) of the wheel in order to move from the second sealing position to the third opening position. The display has a red color in the window of the display provided on the back cover. Red indicates that the cartridge has been opened and the sample may have been tampered with by the opening.

The cartridge device has a flat surface at the tip for barcode labeling. The barcode is unique to each instrument and allows tracking of sample identification and information in the database of the automatic sample storage unit. The barcode label may be bonded to an RF tag provided on the plastic body of the cartridge.

Typically, the cartridge instrument of the present invention can be used to analyze samples using PCR techniques. One of these analyzes is DNA in forensic studies
There is an analysis. The suspected blood sample can be stored in a cartridge device for further DNA analysis, which protects it from possible contamination, UV degradation or sample modification. In addition, the tamper proof mechanism has proven that no alteration or replacement of the sample has occurred, ensuring that a DNA analysis of the suspect's blood sample has been performed.

Another possible use of the cartridge of the present invention is a paternity test. The user must place a drop of blood on the absorbent paper (substrate) in the cartridge, close the cartridge, and the deliverer must deliver it to the laboratory for analysis. The tamper evident mechanism indicates to the laboratory whether the cartridge was opened during shipping, which could mean whether the sample was modified. Since the sample is identified by the barcode,
The confidentiality of test results is guaranteed.

Automatic Sample Storage System The system of the present invention illustrated in FIG. 4 is a closed temperature management unit with movable shelves for safe and optimal storage of samples. Samples are stored in cases on mobile shelves, and the correspondence between sample and sample locations within the unit is managed in a database using barcodes and / or RF tags that identify sample and case locations.

In order to avoid misuse of the sample, there are several levels of security when approaching the sample.
The unit is closed with a locked door. To unlock these doors,
The user must enter an ID and password in the user interface to prove that he is an authorized user of the system. Information about storage unit usage is managed in a database. In addition, the door is equipped with a detector that detects that the unit has been tampered with. Information about tampering with the unit is managed in a separate "black box" that has its own power supply.

Placement of the sample into the unit is performed using the openings on the side of the system. 2
Any support can be used for the simultaneous placement of two or more samples.

When the sample is inserted into the unit, its barcode and / or RF tag is read. If this is the first time this sample insertion, the user can enter additional data about the sample via the user interface. A horizontally moveable pick and place instrument, seen in Figures 5A-B, transports the sample to the empty case on the shelf of the unit. This horizontally movable pick-and-place device has a linear positioning
It consists of a robot arm that uses a two-axis system. A grip is provided at the end of the robot arm so that the sample can be handled, rotated and the sample selected and placed on a shelf. The grip is also equipped with a bar code and / or RF scanner to identify the sample number prior to operation.

To remove the sample from the unit, the user can use the user interface to request the sample when entering the sample number on the screen, ie enter specific information about the sample, or Alternatively, scan the bar code that matches the information about the sample. At this point, information about the sample request is recorded in the database of the storage unit. Also, the sample can be automatically removed from the unit depending on the priority of sample analysis. Finally, the rewritable administrative delay (configurabl
After e maintenance delay), put the sample in the discard unit to safely destroy it. The maintenance delay can be rewritten via the user interface. Safe destruction prevents biohazard and protects the sample, preferably
It also protects the biological information contained in biological samples.

All processing performed is stored in the database using user interface software that also controls all operations of the system. This database is
An external security system (external secu
re system) is regularly backed up.

Typically, the storage system can be used to store a sample containing DNA. One of the possible uses is the storage of genes for bioforensic testing. The secure storage unit database manages information about sample requirements and the user needs to be an authorized user authorized to retrieve samples from the storage unit. The sample is also identified by a bar code that secures information related to the sample and enhances the security level of the system.

Automatic Sampling System The system of the present invention may also include an automatic sampling unit.
The unit of the present invention illustrated in FIG. 6 is a ring light (1), two cameras (2 to 3), a linear drive (4), a puncture device (5), an operating device (6), a sterilization unit, a visual inspection station, It is embodied in a casing with a barcode printer, an opening device (7), a software control unit (8) and a user interface (9).

The system of the present invention is used to automatically distinguish a sample from another sample that may be contained on a plurality of different substrates. The sample is preferably a sample containing DNA.

The user can rewrite the system using the user interface to adjust the system for multiple containers. These vessels may be, but are not limited to, microplates, Eppendorf tubes and test tubes.

If the user wishes to identify the sample, first place the container under the camera on the right and take a picture of the container. The system uses the photo to prove that the container is empty. The substance, preferably the cartridge described above, is then inserted into the operating device and placed under the left camera. If the substance is a cartridge,
The opening device opens it. A photograph of the sample material is taken and analyzed.

Using the picture of the substance, artificial visual techniques identify the presence of the sample substance in the substance, the absence of the substance and the case where the sample was previously taken. Artificial visual techniques also optimize sample position. The optimization method uses a mathematical algorithm.

Once the optimal sample location has been determined, the lancing device will sample at that location. The sample is then placed in the container and photographed with the camera on the right to verify the presence of the sample in the container. If another sample is needed, run the optimization method again. If not necessary, sterilize the lancing device in the sterilization unit and remove the container containing the sample from the sampling unit.

The sampling system is preferably connected to the sample storage unit described above. When the sampling unit takes a picture of the material that is the sample, it compares the visual distinguishing properties of the material with those previously stored in the database of the storage unit.
After taking the sample, the new visual signature is replaced with the database of the storage unit. The storage unit and sampling unit interact with each other using TCP / IP protocols and SQL queries.

Although the present invention has been described with reference to exemplary embodiments, it will be appreciated by those skilled in the art that numerous modifications can be made. Therefore, the foregoing description and accompanying drawings should be considered as illustrative of the invention and not in a limiting sense.

[Brief description of drawings]

FIG. 1 illustrates a front view of one possible configuration of a cartridge embodying the present invention.

FIG. 2 illustrates a cross-sectional view of one possible configuration of cartridge.

3A-C illustrate a front view of a tamper evident locking and indicator mechanism. FIG. 3A illustrates the tamper evident locking and indicator mechanism in an initial position prior to cartridge closure. FIG. 3B illustrates the tamper evident locking and indicator mechanism when the cartridge is closed. FIG. 3C illustrates the tamper evident locking and indicator mechanism after opening the cartridge.

FIG. 4 illustrates an automatic sample storage system.

5A-B illustrate a horizontally moveable pick and place device.

FIG. 6 illustrates an automated sample pretreatment system.

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] August 20, 2002 (2002.20)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Claims

[Correction method] Change

[Contents of correction]

[Claims]

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) G01N 35/00 G01N 1/28 L (81) Designated country EP (AT, BE, CH, CY, DE, DK) , ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, TR), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML) , MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP , KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW F terms (reference) 2G045 BB19 CA25 CB01 CB03 CB07 CB09 CB14 CB16 FA19 HA06 HA12 HA13 HA14 HA16 JA01 JA07 2G052 AA30 AB20 AD26 CA03 CA46 CA48 DA12 DA13 DA21 DA22 DA27 DA31 FD18 HB04 JA00 JA02 2G058 BB03 BB06 CA02 CF11 EA11 GC02 GC03 GC05 HA00 [Continued Summary]

Claims (19)

[Claims] 1. A cartridge for containing a sample, the sample comprising: a housing; a lid capable of sealing the housing; and a user indicating to the user whether the lid has been removed from the housing. A tamper proof system coupled to the cartridge that allows a user to determine if it may be contaminated, replaced, or tampered with,
cartridge. 2. The tamper evident system has a first position that indicates to the user that the cartridge is not in use, a second position that indicates to the user that the cartridge is sealed, and the cartridge has been opened. The cartridge according to claim 1, further comprising a movable indicator at a third position indicating to the user. 3. The cartridge of claim 1, wherein the tamper evident system is coupled to the lid. 4. The cartridge of claim 1, wherein the lid comprises a sample substrate attached to it. 5. The cartridge according to claim 1, wherein the sample is a biological sample. 6. A tamper evident system having an indicator having first and second receiving positions for receiving a stopper for maintaining the indicator in a first opening position or a second sealing position, and a first opening. A component comprising first engaging means for engaging the first and second stowed positions to move the indicator from the position to the second closed position, the third open position, The cartridge according to Item 3. 7. The stopper is coupled to a component, the component further comprising second engaging means for engaging a corresponding receiving means provided on the housing, thereby sealing the housing. The cartridge described in. 8. The cartridge of claim 1, wherein the tamper proof system further comprises means for locking the cartridge. 9. The cartridge of claim 1, further comprising a desiccant. 10. An apparatus for storing a sample, comprising: a housing, a sample accommodating means provided in the housing, automatically inserting the sample into the sample accommodating means, and removing the sample from the sample accommodating means. Of the sample handling equipment and a user interface coupled to the control unit for controlling the sample handling equipment. 11. The apparatus of claim 10, wherein the cartridge contains a sample, the housing, a lid capable of sealing the housing, and whether the lid has been removed from the housing. A tamper-evident system coupled to the cartridge that allows the user to determine if the sample may be contaminated, replaced, or tampered with by indicating to the user,
apparatus. 12. The device according to claim 10, wherein the control unit comprises a database that records the insertion and / or removal of the sample each time. 13. The sample handling device comprises:   A carrier device mounted movably in the housing,   An arm coupled to the carrier,   A grip connected to the arm for gripping the sample, The device according to claim 10. 14. The sample is contained in a cartridge with a barcode and / or RF tag and the grip comprises a barcode and / or RF scanner.
The apparatus according to claim 13. 15. The device of claim 14, wherein the sample is a biological sample. 16. An apparatus for automatically sampling a sample, comprising: a CPU, a CPU for scanning the sample and identifying an optimum position for sampling the sample.
An apparatus comprising a camera coupled to and a sampling device for sampling the sample at an optimal position. 17. The sample is contained in a cartridge with a barcode and / or RF tag and the grip comprises a barcode and / or RF scanner.
The apparatus according to claim 16. 18. The device of claim 17, wherein the sample is a biological sample. 19. The apparatus of claim 16 comprising means for comparing the visual signature of the sample with the visual signature previously recorded in the database.
The database includes a housing, a sample means provided in the housing, a sample handling device for automatically inserting the sample into the sample holding means and removing the sample from the sample holding means, and for controlling the sample handling device. And a user interface coupled to a control unit comprising a database, the apparatus being arranged in a storage unit.