Chemistry: analytical and immunological testing – Automated chemical analysis
Reexamination Certificate
2002-04-15
2003-11-25
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Automated chemical analysis
C235S462130, C702S084000, C700S266000
Reexamination Certificate
active
06653139
ABSTRACT:
FIELD OF THE INVENTION
The invention relates generally to testing an analyte for presence of a selected substance, and more specifically to a method for testing urine or other bodily fluids for selected drugs.
BACKGROUND OF THE INVENTION
Employers today often require prospective employees to undergo preemployment drug screening, to test for use of selected illegal drugs. Testing for drugs is done not only to ensure that an employer is hiring employees whose work will not be affected by drug use, but also to screen for drug use in other environments. For example, those undergoing drug use rehabilitation may undergo regular drug tests to ensure that they are no longer using drugs. Prison residents may also be subjected to regular drug tests to ensure that they are not using drugs in prison. Selected employees in jobs with a high degree of responsibility may be regularly screened for drugs, such as truck drivers being screened to ensure they are not using drugs while driving and law enforcement officers being screened for drugs to ensure their actions while working are not affected by drug use.
Typically, a prospective employee or other test subject is asked to provide a urine sample in a controlled environment, and the sample is sent to a laboratory to be tested for drug presence. This requires that the urine sample be positively identified and securely shipped to the laboratory, where the sample and the results of the test must be matched to the person undergoing the drug screening. The employer must then not only wait for the transported sample to arrive at the lab, be tested, and for results to be sent back, but must undergo the expense of transportation and laboratory testing for each subject tested for drugs.
On-site tests exist to provide initial screening results, and so can provide an initial indicator of whether the subject has used drugs recently, but are not sufficiently accurate to replace laboratory testing as a legally defensible means of confirming the presence of illegal drugs. The on-site screening tests may however be made sensitive enough to reliably indicate that a subject may have used drugs when predetermined quantities of illegal drugs are present in the subject's urine. A non-negative indication from an on-site screening device is therefore not F positive indication of drug use, but an indicator that the subject very likely may have used drugs. However, a negative indication from an on-site screening device indicates that the test subject is extremely unlikely to have sufficient quantities of illegal drugs in his urine to fail a laboratory screening test This means that a negative result can be reliably used to determine that a subject has not used drugs and no farther testing is necessary, but a non-negative result requires verification by a laboratory before concluding the subject has used drugs.
But, the problems of communicating results between the on-site screening site, the testing laboratory, and the client remain, as do the problems with tracking shipped urine specimens for non-negative on-site test results. What is needed is an inexpensive and efficient means to collect and communicate this information, and to track data related to each test subject.
SUMMARY OF THE INVENTION
A method for testing an analyte for the presence of selected materials is provided, including a method of efficiently and inexpensively managing related data. In one embodiment, a trained and certified collector collects a urine sample in one or more containers that may be sealed, and the seals are verified bar the test subject. An on-site screening test is performed and a provided form is completed with screening test results, test subject identification and chain of custody information. An electronic image of the form or other representative data is then sent to a central data location where it is automatically recognized and the data written thereon is stored. In one embodiment, an on-site screening test device reader reads data from the test device and sends the information to the central data location. A container and a paper copy, of the form or other identifying data are sent to a lab if the screening test result is nonnegative. The lab receives the container and tests the urine, recording the results with the data recognized and stored from the form image. The combined stored data is then sent to the client requesting the test.
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Braun Richard J.
Schoonover James A.
Fredrikson & Byron , P.A.
Medtox Scientific, Inc.
Wallenhorst Maureen M.
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