On-site Machine readable assaying system

• US 5,929,422 A
• Filed: 04/04/1997
• Issued: 07/27/1999
• Est. Priority Date: 04/04/1997
• Status: Expired

• Current Assignee: Escreen Inc (Abbott Laboratories)
• Original Assignee: National Medical Review Office, Inc.
• Inventors: Lappe, Murray
• Primary Examiner(s): Hajec, Donald
• Assistant Examiner(s): Dunn, Drew A.
• Application Number:
  US08/832,957
• Time in Patent Office: 844 Days
• Field of Search: 235/462, 235/375, 235/499, 235/462.04, 235/462.13, 235/462.01, 422/56, 422/66
• US Class Current: 235/462.13
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G06K 19/10 at least one kind of marking being used for authentication, e.g. of credit or identity cards verification of coded identity or credit cards in mechanisms actuated by them G07F7/12
• CPC Class Codes: G06K 2019/06253 for a specific application

Abstract

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.

Claims

1. An on-site machine readable assaying system for detecting the absence of proscribed substances in human physiological fluids such as urine, said fluids emanating from a donor individual, comprising:

a) a test card; and

b) machine readable assaying means comprising at least one individual analysis strip imprinted upon the test card, each analysis strip consisting of reagents which are capable of analyzing, detecting and visually signaling the presence of proscribed substances within human physiological fluid, at least one fixed strip and at least one blank region also located upon the test card, organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting a proscribed substance, will change from a first color to a second darker color, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein.

2. The on-site machine readable assaying system of claim 1, wherein adulteration detection means which are capable of determining whether a particular specimen of physiological fluid such as urine has been tampered with are located upon the test card.

3. The on-site machine readable assaying system of claim 2, further comprising quality control indication means which are configured to generate a signal upon contact with physiological fluid, regardless of the presence of proscribed substances, to ensure that the analysis strips of the machine readable assaying means are functioning properly.

4. The on-site machine readable assaying system of claim 3, wherein the adulteration detection means and quality control indication means are configured within the pattern of analysis strips, fixed strips and blank regions which comprise the machine readable source of data.

5. The on-site machine readable assaying system of claim 4, wherein a machine readable pattern encoding test card production information is located upon the test card.

6. The on-site machine readable assaying system of claim 5, further comprising alignment aids located upon the test card for assisting in the alignment of the test card for reading by an appropriate device.

7. The on-site machine readable assaying system of claim 1, further comprising

a) a test card reading unit for scanning and decoding the encoded machine readable data source on the test card;

b) a controller module comprising a processor and a memory unit, the processor capable of processing and the memory unit of storing the decoded machine readable source of data gathered by the test card reading unit; and

c) a communication module and a communication link, the communication module capable of transmitting the decoded data processed by the processor and stored in the memory unit to a distinct location such as a central laboratory via the communication link.

8. The on-site machine readable assaying system of claim 2, further comprising

a) a test card reading unit for scanning and decoding the encoded machine readable data source on the test card;

b) a controller module comprising a processor and a memory unit, the processor capable of processing and the memory unit of storing the decoded machine readable source of data gathered by the test card reading unit; and

c) a communication module and a communication link, the communication module capable of transmitting the decoded data processed by the processor and stored in the memory unit to a distinct location such as a central laboratory via the communication link.

9. The on-site machine readable assaying system of claim 7, further comprising a user interface module, the user interface module having a keyboard for allowing an individual to input certain data which is transmitted by the communication module along with the decoded and processed information gathered by the test card reading unit.

10. The on-site machine readable assaying system of claim 8, further comprising a user interface module, the user interface module having a keyboard for allowing an individual to input certain data which is transmitted by the communication module along with the decoded and processed information gathered by the test card reading unit.

11. A method of utilizing the on-site machine readable assaying system of claim 7, comprising the steps of:

a) bringing the volume of physiological fluid which has emanated from the donor into contact with the machine readable assaying means located upon the test card;

b) allowing a fixed period of time to elapse; and

c) placing the test card reading apparatus adjacent to the test card, in order to scan and decode the encoded machine readable data source contained thereon.

12. The method of claim 11, further comprising the step of:

a) transmitting the decoded data to a distinct location, by means of the communication link.

13. A machine readable assaying system comprising:

a) a test surface having machine readable bar-code indicia imprinted thereupon; and

b) analysis means configured within said machine readable bar-code indicia, capable of detecting and optically signaling the presence of a desired state, wherein the analysis means, upon detecting said state, cause the configuration of the machine readable bar-code indicia to change from a first configuration to a second configuration, thus producing encoded data in the second configuration which is distinct from that data which was previously encoded in the first configuration.