MXPA97008669A - Device for the collection, testing and shipment of body fluid samples - Google Patents

Abstract

A drug abuse testákithas a transparent cup-like container for retaining a fluid sample to be tested and the open top end of the container is closed by a closure cap seated upon the open end . There is a slit in the closure cap to receive a multiple drug testácard having a plurality of immunoassay testástrips thereon with visual endpoints to indicate presence or absence of a particular drug. The container is provided with a second cover which is solid and unslit to close and seal the container when a sample therein is to be transported.

Description

MECHANISM FOR THE COLLECTION, TESTING AND EMBARKING OF FLUID SAMPLES RELATED REQUESTS For purposes of the United States of America, this is a partial continuation of the application of United States Patent Series No. 08 / 613,487 filed March 1, 1996.

TECHNICAL FIELD The present invention a test kit for the collection and testing of urine samples for narcotic abuse and subsequent shipment of the sample, more particularly, to a case of samples having a container and a test card for indicating relates visually presence of particular drug in excess.

STATE OF THE ART The increasing availability and use of medications in excess by the general population has generated patterns, government agencies, sports groups and other organizations using evidence of narcotics remains as a condition of employment and in order to maintain safety at work. Generally the tests of medical remains are carried out for the purpose of quickly identifying on a qualitative basis the presence of drugs in a fluid body which can be urine. A complete analysis of the sample can be carried out in a laboratory if the preliminary results of the remains are positive. More and more such medical remains are being carried out at the site or place of work and are being carried out by proven personnel who are not technically trained as laboratory technicians. Therefore, it is important that the procedure for these medications be simple but formal. In addition, the test apparatus must be as capable as the personnel to avoid all contact with the fluid specimen which is being examined.

Various forms of mechanisms for the collection and transport of fluid bodies, such as urine, have been proposed, which have proved uncomfortable to operate as they involve a number of separate steps. Initially, the sample is collected and several additional steps are required to transfer the urine sample to an analytical apparatus. This multiple procedure required the manual handling of the specimen by several devices and the use of such transfer mechanisms inevitably caused spills which could contaminate the examiner and his environment. In short, the non-technical personnel who carried out the urine sample tests stated that they did not agree with the handling because of the risk of entering with any kind of contagion with the urine sample and even the handling of the sample itself.

Many of the known test apparatus were decidedly complex to include a container for the specimen and, subsequently, it was necessary to transfer the specimen or at least a portion of it to another compartment of the container in order to carry out the test. This transfer of the specimen required vigorous handle the container or turning the container upside down with ei to cause the flow of the specimen within the test compartment which therefore necessary to make the proof container under such condition and ios result leaks were a complicated and expensive structure.

In addition, the containers incorporated the structure by means of which the strip with the reagents was mounted in a test compartment and such a structure also made it possible for the fluid sample to flow into the compartment in contact with the reagent strip. Such a reagent strip assembly further results in complications of the container structure since it is necessary for that provision made to view the reagent strip outside the container. This was accomplished by providing a transparent window or some other assembly of the reagent strip to be visible to the examination personnel.

DISCLOSURE OF THE INVENTION This is, therefore, the main object of the present invention, namely to provide a simplified and economical device for the collection and analysis of fluid samples, particularly urine for narcotics abuse and subsequent shipment of the sample.

It is a further object of the present invention to provide such a mechanism that includes a closed container for retaining a urine sample having a closed structure, with the test card having a plurality of test strips that can be inserted into the container so that the strip of test come in contact with the urine sample.

It is still another object of the present invention to provide an analysis card having a plurality of immunoassay test strips on it, with each strip being sensitive to a particular narcotic in excess and having a visual end point to indicate the presence or absence of a narcotic. in particular.

The objectives of the present invention are being realized and the disadvantages of the above trade are eliminated for the narcotic test according to the present invention which may comprise a transparent cup-shaped container for retaining a urine sample upon examination. The lid of the container has a closed cover or lid and there is a diametral opening in it. The opening is of a certain size to accommodate the test card which has a plurality of immunoassay test strips mounted parallel to one side and each test strip gives its corresponding narcotic. The card is inserted through the slot so as to have an end immersed in the urine sample at a certain depth so that the results of each separate analysis can be seen through the transparent wall of the container in removing the card from the container to which indicates the presence or absence of a particular narcotic in the urine sample. If the sample is "positive" to indicate the presence of a narcotic in the urine, then it is necessary to send the sample to a certified laboratory for confirmation of the analysis. For this purpose, a second layer is placed which is solid, that is, not cut, provided and which can be threaded into the final opening of the container. The test card is removed from the container, the solid layer is put in the closed container and is ready to be taken to the laboratory.

As described above, the test kit includes an excess narcotic within the test mechanism for the collection and analysis of the urine sample. This mechanism is comprised of a container having a transparent wall and a lid which is threaded to a closed cover and with a slit to put the test card. A second solid and closed layer that is threaded on the outside of the container and sealed to allow safe transport of the fluid sample.

The test kit also includes an analysis card with an excess narcotic screen which is comprised of a thin, flat membrane having the size and shape of a business card. A plurality of immunoassay test strips are held side by side parallel to one side of the test card without exceeding the contour thereof. Each test strip is reactivated giving a visual indication in response to an excess narcotic. Thus, this card gives a simultaneous detection of multiple analyzes.

BRIEF DESCRIPTION OF THE DRAWINGS Other objects and advantages of this invention will apparently be in reference to the following description when taken into account in conjunction with the following drawings, which are explained by way of example here; Fig. 1 is a perspective view of the narcotics abuse analysis kit according to the present invention generally showing the container, the card partially inserted in position for testing in the container through a slotted lid; Fig. 2 is an exploded perspective view of the container according to this invention for the collection and testing of a fluid sample and generally showing the container, a lid with an opening covered with a removable adhesive seal and a second solid layer; Fig. 3 is a plane seen from the test side of a card according to the present invention; Fig. 4 is a plane seen from the opposite side of the card shown in FIG.

Fig. 3; Fig. 5 is the final view height of the card shown in Fig. 3; Fig. 6 is a sectional view taken along lines VI-VI I of Fig. 3; Fig. 7 is a plan seen of the two open pieces of the card before being bent to form the card shown in Figs. 3-6; Fig. 8 is a plane seen on the test side of a modification of the card; Fig. 9 is a plan seen of another modification of the card; Fig. 10 is a sectional view taken along lines IX-IX of the Fig. 8; Fig. 1 1 is a plane seen from the test side of one further modification of the card; Fig. 12 is a plane seen from the central fold of the card of Fig. 1 1 and showing a strip in a groove thereof; Fig. 1 3 is a plane seen on the opposite side of the card of Fig. 1 1; Fig. 14 is a sectional view taken along lines XIII-XIII of Fig. 1 1; WAYS TO CARRY OUT THE INVENTION As can be seen in Figs. 1 and 2, a kit of excess narcotic tests in accordance with the present invention is generally indicated by 10 and comprises a transparent test container or something. similar to a cup 1 1 having a cylindrical wall 12, a closed base 13 and an open upper end 14. The cylindrical wall 12 may have a light conical shape or be vertical.

The upper part 14 of the container 1 1 is provided with external lines 21 on which the outer layer or cover 22 is supported, supplied with corresponding internal lines that are not shown in the drawing. The cover 22 has a circular surface 23 for the periphery on which a cylindrical wall 24 depends on the inner surface in which there are internal lines. The surface of the lid 23 has a diametric incision 19 in this form to accommodate the card as will be presented later. There is also provided a cover or solid layer 15 which is similar in size and shape to the cover 22 but is solid or without an incision so that the covers 15 and 22 can be exchanged when mounted on the top 14 of the container 11. During transport, the cover 1 5 is generally prepared at the base of the container. A strip for taking the temperature 16 is placed on the base of the side of the wall of the container so as to be in accordance with the temperature of the sample without a container.

A card 25 which will indicate the presence or absence of any of the 5 different drugs in excess is shown in Fig. 1 inserted in the incision 19 in the closed lid 22 and in more detail in Figs. 3-6. The card is multipurpose as it has five strips to detect 5 different narcotics. Strips 26-30 are spaced parallel to one side of the card. These strips indicate the presence or absence of excess narcotics; PCP, cocaine, amphetamines (AMP), marijuana (THC) and opiates. Strips may be of the type such as those made by Bionica South of San Francisco, California, San Diego Pharmaceutical Technology, California and Arista Biological of Bethlehem, Pennsylvania. These strips are characterized as strips of immunoassays and employ colloidal gold chemistries. Each strip is dipped as far as the indicator line at 32 and the results of the test are read in the test area indicated at 33. A blue line in the test area indicates positive or the presence of a particular narcotic in the sample .

The strips are usually placed, separately, in slots of the card thereby the portions of the strips project the surface of the test 31 of the card as can be seen in Fig. 5. The card can be formed by two folds 34 and 35 as can be seen in Fig. 7 and these folds when turning them are formed of a simple strip having a band or fold 36. The fold 35 is formed mostly by slits 37 cut to which they are shaped and size to receive each of the strips. Therefore, in the manufacture of a card for analysis, the two portions 34 and 35 are bent at the end 36 and are adhered together. The strips are placed in the slots as shown in Fig. 6 and each of the strips is adhered to the surface of the first portion 34 on which the second portion 35 has been folded.

It is even within the scope of this invention to make this card of two separate or individual folds 34 and 35 which are then bonded together and the strips are fixed in the slots as described above.

In order to conduct an examination for excess narcotics when using the card according to the present invention, for a person to examine himself he must first provide a urine sample in a transparent container 1 1. The amount of sample provided must be such as to allow insertion of the card up to the indicated stop at 32. It is also possible to provide full lines on the surface of the container wall.

The container with sufficient amount of specimen to be examined there is closed with the lid 22 on top of the bottle. The lid 22 has an easily removable adhesive seal 18 which is placed in the groove 19. Therefore, when the container with the specimen to be analyzed is taken to the person making the test, the protective strip 18 is removed and the card Multiple is inserted into the slot so that the card's wedge rests on the base of the container. Fifteen (15) ml. of the sample will assure the rest that it did not reach the maximum of line 32. Then the card remains in place for at least three minutes and the results of the test can be read on each individual strip through the transparent wall of the container. Therefore if a blue line appears on any of the strips they are indicating "positive test" with the presence of a particular narcotic in the analysis of the specimen. Conversely, if it does not appear, the blue line is indicating the absence of any of the five drugs in the specimen. With this negative result, the urine sample and the container are discarded.

However, when the results of the test are positive, it is preferable to send the specimen to a certified laboratory to confirm the analyzes with more specific methods such as chromatographic gas or mass spectrometry. In order to transport the sample in the container, the cover 22 is removed and the solid cover 15 is fixed down firmly at the open end of the container.

In Fig. 8, a modification of the above-described card is shown at 40 and similarly constructed with two folds but is also provided with a third fold 41 which is adhered to the other two and covered with the strips. The third game is provided with an opening 42 through which you can see the lines of control and analysis. In this modification those portions of the folds below the maximum of the line are removed so that the 26-30 strips are projected beyond the final base 43 of the small card. Otherwise, the functions of this card were described accurately above.

A modification of the card 44 is shown in Fig. 9. In this modification, the strips are covered but the relevant test and the portions of the strip sample are exposed through the openings. The card 44 comprises a central styrene fold 45 which has a thickness of 1.2 mm. corresponding to one slightly larger than the thickness of the strips and grooves that are in the center of the fold to receive the strips. The upper and lower faces of the fold are covered by a lower fold and an upper fold which can be made of a single piece of material qualified at 48 and 49 and thus wound around the central fold 45 of styrene which has a thickness of 1. 25 mm. corresponding or slightly larger than the thickness of the strips and the grooves that are in the central fold to put the strips. The upper and lower part of the faces of the central fold 45 are covered by a lower fold 46 and an upper fold 47 which can be made of a single piece of doubly qualified material in 48 and 49 to roll it up around the central fold 45 in the manner as shown in Fig. 9. The top and bottom of the fold can be a thin vinyl sheet or cardboard covered with plastic. The top of the fold 47 has a majority of advantages 50 through which the already given test results can be seen. At the lower end of the card are provided the sample openings 51 through which the liquid of the specimen is able to contact the absorbent or portions of the sample of the strips.

In Figs. 1 -14 shows a modification of the card 44 in which the card is made of three separate folds which are laminated. The lower and upper part of the folds 46 and 47 are made of a vinyl sheet having a thickness of 0.33 mm. and the center of the fold 45 is made of styrene having a thickness of about 1.25 mm. The upper part of the fold 47 has similar openings or windows 50 and the openings of the sample 51 and the lower part of the fold 46 are solid as shown.

The central fold 45 has mostly slots extended along 52 and a strip 53 is placed in each of the slots as shown. The strip generally has a length less than that of slot 52. Within this manufacture, only a single strip for THC (marijuana) is shown. While this card manufacture has provision for five strips, it is understood that the card can be made in the same way with less than five strips and even one if desired. In such modification, the spaces 50 and 51 of the strips omitted are generally solid.

Each of the strips 26-30 is an immunoassay step in which a special drug (conjugated drug) is competed with the narcotic which can be presented in the sample for the limited number of bands located in an antibody. The strip consists of a clear membrane on which a narcotic conjugate has been immobilized. A complex colloidal antibody is dried at the end of the membrane. In the absence of any narcotic in the urine sample, the colloidal complex antibody moves with the urine sample by capillary action upon contact with the immobilized narcotic. An antibody-antigen reaction is formed by forming a visible line in the test area. The formation of the visible line in the test area of the day when the analysis is negative for the narcotic. When a narcotic is present in the urine sample, it or its metabolism will compete with the conjugated and immobilized narcotic in the test area for the limited antibody located in the labeled antibody complex. If a sufficient amount of narcotic is present, it will fill all available sites, thus preventing the attachment of the labeled antibody to the conjugated narcotic. The absence of a color line or band in the test area is indicating a positive result. The control of the band or line was comprised of a different antibody-antigen reaction present in the membrane of the strip. The control line is not influenced by the presence or absence of narcotic in the urine and therefore must be present in all reactions.

In short, if a single band appears in the control zone and no band appears in the test area then the results are "positive" which indicates that the particular drug is present at a predetermined level which is generally about 50 micrograms / ml. If two color bands appear, one in the control region and the other in the test region then the results are "negative" which indicates that the level of that particular narcotic is below the predetermined detection of sensitivity.

In the event that there are no visible and distinct color bands either in the test area or in the control zone or if there is a visible band in the test area but not in the control zone, then the result is invalid and The specimen will be examined again with another card.

The card can also be used as a hauling and delivery system for a biological detection or monitor by replacing the test strips with strips treated with suitable chemicals as well as being compliant with biologically different and selective combatant agents. The strips could then function similarly to excess narcotic strips which give a visual indication of the presence in a predetermined amount of a biologically specific combatant agent or the absence of such an agent.

INDUSTRIAL USE Thus it can be seen that the present invention discovers a new and improved test kit for the detection of drugs which is comprised of a container for the fluid specimen being tested and a multiple card which is inserted into the specimen inside the container and the results Visuals of the test are read on the card through the transparent wall of the container. The card therefore comprises a number of individual strips of immunoassay type and each stripe will give or indicate the excess of a particular narcotic. The card can be made of plastic covered with cardboard or thin sheets of plastic which are laminated together. This test kit for the detection of narcotics allows you to quickly obtain a visual and qualitative result which is very advantageous for forensic purposes, but is not limited to such purposes.

It will be understood that this invention is susceptible to modification in order to adapt it to different treatments and conditions, and indeed, if it is desired to understand such modifications within this invention as it may fall within the field of fixed demands.

Claims (15)

1. A test kit for the detection of narcotics comprising a container in the form of transparent rate having an upper cavity for retaining a sample of urine to be analyzed, a closure cap located at said open end and having a diametrically disposed groove, a card analysis having a plurality of test strips with visual indication placed in parallel on one side and each strip forming the detection a narcotic in particular, said card having such width and thickness that one end of the card can be inserted through the slot before indicated to be immersed in a urine sample that is retained there, at a certain depth, the results of each strip can be seen through the transparent wall of the container without removing the test card from the container to indicate the presence or absence of a particular narcotic in said urine sample.

2. A test for the detection of narcotics as said in the first point is further comprised of a second lid closure positionable on the open end of the container instead of said lid with a slot.

3. The mechanism of the test for collecting and examining a urine sample is comprised of a transparent cup-shaped container having an open upper end, for holding the urine sample to be analyzed, a first lid located in said upper cavity and having a diametral groove disposed there, and a second solid cap placed above said open upper end in place of the first cap to seal the container and thus allow the transportation of the fluid sample there without dripping.

4. A test method for the detection of excess narcotics as claimed in clause 3 and further comprises a protective adhesive tape in said slot which is previously removed for the analysis of the specimen in the container.

5. A multiple card for the detection of narcotics comprising a flat and thin member having the size and shape of a business card and having a first side, a plurality of strips of immunoassay tests, with visual endpoints to indicate the presence or absence of a narcotic, adhered side by side in parallel on said first side within the contour of the flat member and having at least portions thereby exposed, each strip indicating the presence or absence of a particular narcotic.

6. A multiple drug presence test card as claimed in claim 5 wherein said test strips are located on said first side.

7. A multiple card as claimed in claim 5 wherein said strips are arranged parallel to the long dimension of said planar member.

8. A multiple card as claimed in claim 5 wherein there is a plurality of parallel slots spaced apart on said first side and said strips are seated in the slots.

9. A multiple card as claimed in claim 5 wherein the exposed portions of said test strips are placed inside the first side surface.

10. A multiple card as claimed in claim 5 wherein said flat and thin member comprises three laminated sheets, one of these sheets defining a backing sheet, a second of said sheets having a plurality of parallel slots for there receiving the test strips , and a third of said laminated sheets having parallel grooves with corresponding space with the test strips, said sheets are adhered together so that the first and third make a sandwich with the second between them. eleven .

A multiple card as claimed in claim 5 wherein said thin flat member has front and rear surfaces and a thickness substantially equal to the thickness of the strips, the grooves being there in the flat member to receive the strips therein, a second member flat adhering to the rear surface thereof, a third flat member adhered to the front surface of said flat member, said third flat member having openings for exposing the sample and the test portions of said test strip.

12. A multiple card as claimed in claim 5 wherein said second and third member comprise a single sheet of material having a fold therein and folded into itself and folded around said first flat member.

13. A multiple card as claimed in claim 1 wherein the second and third flat members are thinner than said first flat member.

14. A multiple card as claimed in claim 5 wherein said test card has a lower end and said test strips have ends projecting outwardly from said lower end.

15. A multiple card as claimed in claim 14 and further comprising a cover sheet for covering said first side of said flat and thin member and said test strips, an opening being there in said cover sheet for exposing the portions of said test strips.