US 20050214865 A1
A machine readable assaying system comprising a test card having machine readable assaying means. A plurality of individual analysis strips, each strip comprising antibodies and/or reagents capable of indicating the positive presence of distinct illicit substances form a pattern of elements including one or more fixed strips and one or more blank regions. The detection of the presence of a particular substance or drug will result in one or more of the analysis strips changing from a first (light reflective) color to a second darker (light absorbent) color. The pattern of analysis strips, fixed strips and blank regions may be provided to encode one or more characters/digits of information. By the inclusion of the analysis strips with the plurality of fixed strips and blank regions, the detection of one or more illicit substances may alter the overall pattern of fixed and test strips and blank regions, and hence cause the encoded information represented thereby to be altered. Accordingly, the particular pattern of bars and spaces that result from an exposure the physiological fluids of a donor is contemplated to produce a distinct machine readable indicia. The transformation which occurs on the test card will be uninterpretable by the administrator of the test, thus preserving the anonymity and privacy of the tested individual.
1. A method of carrying out a test to detect for the presence or absence of a target substance in a human donor-derived physiological sample, said method comprising the steps of:
providing: (1) a test surface adapted to contact said sample and having at least one machine-readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with said sample; and (2) a scanning unit capable of scanning said machine-readable indicium on said surface, said scanning unit including a programmed processor and a memory unit;
contacting said test surface with said sample; and
after said contacting step, using said scanning unit to scan said at least one indicium, and operating said processor to generate test data as a result of said scan,
said indicium being machine-readable only and not human interpretable in the absence of said machine reading.
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7. Apparatus for carrying out a test to detect for the presence or absence of a target substance in a human donor-derived physiological sample, said apparatus comprising:
a test surface adapted to contact said sample and having at least one machine-readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with said sample; and
a scanning unit capable of scanning said machine-readable indicium on said surface, said scanning unit including a programmed processor and a memory unit,
said scanning unit, operable, upon scanning of said test surface previously contacted with said sample, to generate said test data through operation of said processor.
8. The apparatus of
9. The apparatus of
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11. The apparatus of
This application is a continuation of U.S. application Ser. No. 10/954,823 filed Sep. 30,2004, which is a division of U.S. application Ser. No. 10/779,014 filed Feb. 13, 2004, which is division of U.S. application Ser. No. 10/072,154 filed Feb. 6,2002 (now U.S. Pat. No. 6,716,393), which is a division of U.S. application Ser. No. 09/444,926 (now U.S. Pat. No. 6,514,461) filed Nov. 24, 1999, which is a Continuation-In-Part of U.S. application Ser. No. 09/245,175 (now U.S. Pat. No. 6,342,183) filed Feb. 5, 1999, and a continuation-in-part of U.S. application Ser. No. 09/025,559 (now U.S. Pat. No. 5,902,982) filed on Feb. 18, 1998, and a continuation-in-part of U.S. application Ser. No. 09/018,487 (now U.S. Pat. No. 6,036,092) filed Feb. 4, 1998, and a continuation in part of U.S. application Ser. No. 08/832,957 (issued as U.S. Pat. No. 5,929,422 and reissued as U.S. Pat. No. RE38,509) filed Apr. 4, 1997, and a continuation in part of U.S. application Ser. No. 08/801,041 (now U.S. Pat. No. 5,916,815) filed Feb. 14, 1997. The disclosures of the aforementioned applications are, by reference, incorporated herein.
1. Field of the Invention
The invention relates to an assaying system. More particularly, the invention relates to a machine readable assaying system for analyzing a specimen of physiological fluid to detect the presence or absence of particular substances therein. In a preferred embodiment, the machine readable assaying system contemplates the utilization of machine readable bar-code patterns imprinted upon a test card which change form in response to a physical, chemical or biological reaction. The test result which is encoded within the bar-code indicia imprinted upon the test card is read by an appropriate decoding apparatus (i.e. a bar-code reader/scanner), and the decoded results are stored in a memory unit and transmitted, if desired, to a distinct location. A test administrator merely scans the bar-code. Because the bar-code patterns change form in such a subtle yet varied manner, the administrator or another observer of the test card is unable to discern the results. Accordingly, the privacy interests of the donor are preserved, as well as human interpretation errors, transcription and translation errors.
The increase in drug use over the past several decades has created a sharp need for more effective, expeditious methods of analyzing whether a particular individual is a user of certain illegal substances. Both private industry employers as well as governmental employers often need to determine whether an individual has drug residue present in his or her biological system, and hence determine whether such an individual is a drug user or drug abuser and thus an unqualified employee.
Typically, the status of an individual as a drug user or abuser is determined by analysis of the individual's physiological fluids, namely urine. A specimen of urine is collected, and a highly sensitive screening test is first performed, usually at a centralized laboratory. If specimen samples screen positive at the central laboratory, then a more sensitive and controlled confirmation analysis must be performed.
In addition to being an extremely costly process, the above mentioned procedure also involves great time delays to employers desirous of obtaining new qualified employees. Upon collection of the urine sample, the employer must wait to receive test results from the central laboratory before hiring any potential employees. Furthermore, the massive amount of handling and transfer of the sample of urine from the initial collection site to the central laboratory.
To combat the above mentioned timeliness problem which faces many employers in awaiting results from the central laboratory, various “on-site” or “hand-held” assaying devices have been developed. A major problem inherent in these “on-site” testing devices is that the privacy concerns of the potential employee being tested are not adequately addressed. Since all of the on-site testing devices available heretofore attempt merely to identify drugs present (i.e. simply to indicate which specimens do indeed possess the prohibited substance/drug), the anonymity of a presumptive positive donor is impossible to conceal. Due to such lack of anonymity, many employers (governmental in particular) will not employ such an assaying system as it does not comply with federally mandated regulations regarding privacy and civil liberties during drug-employment testing. A more anonymous, reliable and expeditious assaying system is needed, wherein negative results can be obtained quickly without compromising the privacy concerns of the tested individual. The results are not “human readable” and thus are not subject to interpretation.
It is an object of the invention to produce an assaying system for analyzing a specimen of body fluid to detect the absence of particular substances therein.
It is another object of the invention to provide an assaying system which provides more anonymous, reliable and expeditious results than those assaying systems presently found in the art, wherein said results can be obtained quickly without compromising the privacy concerns of the tested donor individual.
It is a further object of the invention to provide an on-site, portable assaying system which allows the results of said assay to be determined and utilized almost immediately by an employer, without jeopardizing the privacy rights of the individual being tested.
It is a still further object of the invention to provide an assaying system which allows the results of said assay to be encoded in a machine readable format (such as bar-coding) such that said encoded results are visually undetectable and must be de-coded by appropriate apparatus. Accordingly, the administrator of the assay lacks access to the test results.
It is yet another object of the invention to provide an assaying system which possesses a memory unit to store resultant decoded assay data, and communication means for transmitting said decoded data to a distinct location (such as a central laboratory/processing office). Upon receiving the assay data, the central laboratory/processing office could then electronically, telephonically or manually (via a delivered hard copy) communicate a responsive “negative test certificate” to the employer for those individuals testing negative (indicating that these individuals are candidates for immediate employment). A sample specimen of physiological fluid from only those individuals who tested positive would then be requested by the central laboratory for standard “confirmation” testing.
It is yet another object of the invention to provide an assaying system such as that discussed above which possesses means capable of detecting adulteration of the specimen.
To the accomplishment of the above and related objects the invention may be embodied in the form illustrated in the accompanying drawings. Attention is called to the fact, however, that the drawings are illustrative only. Variations are contemplated as being part of the invention, limited only by the scope of the claims.
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As seen in the arrangement depicted in
It is contemplated in the preferred embodiment that one or more of the individual analysis strips 34 which comprise the bar code indicia of the machine readable assaying means 32 contain reagents or antibodies whose visual appearance is altered in response to physiological fluid, regardless of whether any illicit drugs are present within said fluid. It is further contemplated that these “control” analysis strips 34C be situated such that their detection amongst the pattern of strips 33A and 34 and blank regions 33B (bars and spaces) comprising the bar code indicia does not vary the character of the information encoded therewithin. For instance, the bar code indicia of the machine readable assaying means 32 would indicate, if decoded by an appropriate device prior to contact with physiological fluid, a negative presence of illicit drugs. Upon contact with a volume of physiological fluid which lacks the presence of illicit drugs, the “control” analysis strips 34C will appear. However, their placement amongst the standard test strips 34, fixed test strips 33A and blank regions 33B will not effect the initial encoded character of the bar code indicia. Accordingly, a negative assay will be determined.
The function of the “control” analysis strips 34 is to prevent an administrator of the test from learning the outcome of the assay. If, subsequent to the administration of each assay, some type of change occurs to the visual appearance of the machine readable assaying means 32, then the test administrator will be unable to discern positive test results from negative results. Only the device used to decode the encoded bar code indicia will be able to determine whether the donor's specimen of physiological fluid tests positive for illicit drugs, and if so, which particular substances were present.
The test card 22 of
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One possible embodiment of the test card reading apparatus 60 is seen in
It should be noted that the controller module 62 may be provided by known programmable single chip microcomputers and any additional analog/digital circuitry required. Further, it is contemplated that the controller module 62 may be provided (in an alternate embodiment to that shown in
Another embodiment of the test card reading unit 54 of
The aforementioned configuration of the machine readable assaying system of the instant invention render said system capable of being employed on-site at an employer's individual location. A donor individual is given a collection container and provided a private environment where said donor individual is to excrete a specimen volume of urine into the collection container for analysis. A volume of urine is then brought into contact with the test card 22 (by bathing the test card 22 with a small amount of urine, inserting the test card 22 into the urine, etc.) The quality control indication means 38 and/or the control test strips 34 are then checked to assure the integrity of the assaying means 32. Assuming that the assay is functioning properly, the adulteration detection means 36 are then checked to determined whether the donor individual tampered with the specimen. If the adulteration detection means 36 indicate that the specimen is unadulterated, then the machine readable assaying means 32 are then read by the test card reading unit 54 (such as the scanner 54 a and decoder 54 b). The results of the assay are then stored in the memory unit 62B of the controller module 62 for transmission to a desired location such as the centralized laboratory 58.
Upon the central laboratory 58 receiving the assay data, the names or identification codes of those donor individuals who provided negative results may be immediately communicated to prospective employers, so that those particular donors may be offered employment. All positive assay urine specimens will be requested from the test site by the central laboratory 58 for further confirmation analysis. Accordingly, the employer is immediately provided with a number of qualified potential employees to choose from, and the privacy concerns of the donor individual are safeguarded.