On-site drug testing method

• US 6,376,251 B1
• Filed: 07/21/1999
• Issued: 04/23/2002
• Est. Priority Date: 02/03/1999
• Status: Expired due to Term

• Current Assignee: Medtox Scientific, Inc. (Laboratory Corporation Of America Holdings)
• Original Assignee: Medtox Scientific, Inc. (Laboratory Corporation Of America Holdings)
• Inventors: Schoonover, James A., Braun, Richard J.
• Primary Examiner(s): Bhat, Nina
• Application Number:
  US09/358,340
• Time in Patent Office: 1,007 Days
• Field of Search: 436/43, 235/462.13, 702/84, 700/266
• US Class Current: 436/43
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: G01N 15/14 Optical investigation techniques, e.g. flow cytometry
• CPC Class Codes: G01N 2035/00188 the analyte being in the solid state
• CPC Class Codes: G01N 33/493 urine
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

The invention described herein includes a method of testing an analyte such as urine to determine whether the analyte contains specific substances such as drugs of abuse. An on-site screening test provides a preliminary test result either by visual or machine analysis of a screening test device, and the result and user data are entered on a provided form. An electronic image of the form is sent to a central data location, where it is received and the data on the form is recognized by machine and stored. If the on-site screening test provided a nonnegative result a sample is sent to a laboratory for further testing, and if the test provides only negative results no further testing is done. The testing laboratory performs further testing for verification of nonnegative screening test results, and all data is collected at the central data location. Results are then reported to the client or whoever the client designates to receive test results.

Claims

1. A method of testing an analyte collected at a test site remote from a testing laboratory to determine whether the analyte contains one or more selected substances, comprising:

testing a portion of an analyte sample with at least one on-site screening test;

entering data onto a provided form comprising form identification and written data including on-site screening results and analyte sample identification;

sending electronically an image of the form from the remote test site to a central data location;

receiving electronically the image of the form at the central data location and automatically recognizing and storing the data contained thereon;

sending one or more of at least one sealed containers containing the analyte to the testing laboratory if the on-site screening test provided a non-negative result;

testing analyte from the sent container at the testing laboratory to determine whether the analyte contains one or more selected substances;

storing results of the test with the stored data; and

reporting the stored data.

2. The method of claim 1, further comprising distributing the analyte between at least two containers.

3. The method of claim 1, further comprising sealing each of the at least one sealed containers with a seal comprising identification data and that is verified with a signature.

4. The method of claim 3, further comprising receiving one or more of the sent containers at the testing laboratory and identifying the at least one sealed containers by matching the seal identification data to the scanned and stored data.

5. The method of claim 1, further comprising manually verifying the stored data by comparing it to the received electronic image.

6. The method of claim 1, wherein the analyte is urine.

7. The method of claim 6, wherein the one or more selected substances are one or more selected drugs of abuse.

8. A method of testing an analyte to determine whether the analyte contains one or more selected substances, comprising:

collecting the analyte;

distributing the analyte between at least one container and at least one on-site screening test;

sealing one or more of the at least one containers with a seal comprising identification data and verified by the test subject;

testing the collected analyte with said at least one on-site screening test; and

sending electronically an image of a provided form comprising form identification data and data including on-site screening test results, test subject identification data, and chain-of-custody information.

9. The method of claim 8, further comprising destroying one or more of the at least one sealed containers if the on-site screening test indicates the analyte does not contain the one or more selected substances.

10. The method of claim 8, wherein the analyte is urine.

11. The method of claim 10, wherein the one or more selected substances are one or more selected drugs of abuse.

12. A method of testing an analyte to determine whether the analyte contains one or more selected substances, comprising:

receiving electronically an image of a provided form comprising data including on-site screening test results, test subject identification data, and chain-of-custody information;

recognizing and storing automatically the data contained in the image of the provided form;

receiving one or more sealed containers containing collected analyte and sent from an on-site screening location;

testing the analyte from the one or more sealed containers to determine whether the analyte contains the one or more selected substances.

13. The method of claim 12, further comprising identifying the one or more sealed containers by matching a seal including identification data and verified with a signature on the one or more sealed containers to the scanned and stored data.

14. The method of claim 12, further comprising manually verifying the stored data by comparing it to the received electronic image.

15. A machine-readable medium with instructions stored thereon for execution on a computer, the instructions operable to cause the computer to:

receive electronically an image of a provided form comprising data including on-site screening test results, test subject identification data, and chain-of-custody information; and

recognize and store automatically the data contained in the image of the provided form.

16. The machine readable media of claim 15, further operable to cause the computer to:

store the results of a laboratory test with the stored data; and

report the stored data to a client.

17. A test device reader, comprising:

a test device receiver capable of receiving and holding a test device;

an optical scanner operable to scan an image of a test device held in the test device receiver; and

an electronic circuit operable to analyze the image of the test device and report a test result.

18. The test device reader of claim 17, further comprising an electronic data communications circuit capable of electronically sending a test result to a remote location.

19. The test device reader of claim 17, further comprising a keyboard for controlling the reader and for entering data associated with the test result.

20. A method of testing, comprising:

testing a portion of an analyte with at least one screening test;

entering data onto a form comprising data including a screening test result;

sending electronically an image of the form to a central data location;

receiving electronically the image of the form at the central data location and automatically recognizing and storing the data contained thereon;

sending a container containing a portion of the analyte to the testing laboratory if the screening test provided a non-negative result;

testing analyte from the container at the testing laboratory to determine whether the analyte contains one or more selected substances;

storing results of the test with the stored data; and

reporting the stored data.

21. A method of testing a urine sample collected at a test site remote from a testing laboratory to determine whether a test subject has used one or more selected substances, comprising:

testing urine from the urine sample with at least one on-site screening test;

entering data onto a provided form comprising form identification and data including on-site screening results, test subject identification, and chain-of-custody information;

sending electronically an image of the form from the remote test site to a central data location;

receiving electronically the image of the form at the central data location and automatically recognizing and storing the data contained thereon;

sending one or more of at least one containers containing the urine sample to the testing laboratory if the on-site screening test provided a non-negative result;

testing urine from the at least one container at the testing laboratory to determine whether the test subject has used one or more selected substances;

storing results of the test with the stored data; and

reporting the stored data to a client.