PubMed · 10539648
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1999. Table of reference intervals.. https://pubmed.ncbi.nlm.nih.gov/10539648/
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BACKGROUND: In order to decide on the feasibility of screening for disease by laboratory testing, a number of assessments need to be made. The necessary procedures and statistical calculations are required for an objective evaluation of the diagnostic accuracy of a laboratory test and of the potential for screening and of the data obtained from the screening. METHODS: The determination of reference intervals, is an essential first step in the evaluation of the performance of a laboratory test. The procedures and calculations are necessary for the determination of the sensitivity, specificity, diagnostic predictive value and receiver-operating characteristic curve of a test and their respective applications in laboratory screening for disease. The additional statistical tools include odds ratios and likelihood ratios for assessing the performance of a laboratory test. CONCLUSION: These tools are used in the development of an appropriate clinical decision limit in a defined population of subjects and under defined conditions for acceptable screening.
Oral fluid is becoming increasingly useful for the detection of drugs, since it is a non-invasive specimen to collect and, because collection is directly observed, it is difficult to adulterate. A point-of-collection (POCT) oral fluid drug analysis kit has been developed for use in many drug testing situations. This paper summarizes the results of field evaluations of the ORALscreen System for screening of drugs in oral fluid. The ORALscreen System consists of an oral fluid collection device and a test device containing a lateral flow membrane immunoassay system. Paired samples (oral fluid and urine) were collected from drug users and the results from the ORALscreen POCT system were compared to urine screening results conducted in a licensed laboratory. The results demonstrate that the ORALscreen System has excellent percent agreement with the laboratory-based urine screening test results for the detection of cocaine and opiates through 2.5-3 days following drug use, respectively. Tetrahydrocannabinol (THC) was detected by ORALscreen on the day of use and 1 day after use. Good correlation between urine and oral fluid screening results was observed for the methamphetamine positive samples; however, the number of days following drug use was not determined.
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