Aila Leino1, Britt-Marie Loo. 1. TYKSLAB Laboratory, Hospital District of Southwest Finland, Finland. aila.leino@tyks.fi
Abstract
BACKGROUND: Rapid and sensitive tests for detecting buprenorphine and its metabolites for drug-screening situations have been long awaited. From the tests available, we have evaluated two on-site drugs-of-abuse testing devices using competitive binding immunoassays and one homogeneous enzyme immunoassay measured on an automated analyser. METHODS: A total of 49 urine specimens were tested using three different kits. Two were point-of-care devices, a cassette test, QuikPac II OneStep Buprenorphine Test, and a strip test, QuikStrip OneStep Buprenorphine Test. The other was the CEDIA Buprenorphine Assay performed on a Roche Modular P analyser. The confirmation analyses were performed using liquid chromatography-mass spectrometry. RESULTS: The sensitivities of the three methods ranged from 88% to 100% and specificities from 91% to 100%. All three kits, especially the cassette and strip devices differed markedly from each other with respect to interpretation of the test result and to clarity of the test performance. Increasing the read time of the QuikStrip device from 5 to 30 min resulted in an increase in false-negative test results. CONCLUSIONS: Our results indicate that special care should be taken when selecting immunology-based point-of-care methods for measurement of buprenorphine.
BACKGROUND: Rapid and sensitive tests for detecting buprenorphine and its metabolites for drug-screening situations have been long awaited. From the tests available, we have evaluated two on-site drugs-of-abuse testing devices using competitive binding immunoassays and one homogeneous enzyme immunoassay measured on an automated analyser. METHODS: A total of 49 urine specimens were tested using three different kits. Two were point-of-care devices, a cassette test, QuikPac II OneStep Buprenorphine Test, and a strip test, QuikStrip OneStep Buprenorphine Test. The other was the CEDIA Buprenorphine Assay performed on a Roche Modular P analyser. The confirmation analyses were performed using liquid chromatography-mass spectrometry. RESULTS: The sensitivities of the three methods ranged from 88% to 100% and specificities from 91% to 100%. All three kits, especially the cassette and strip devices differed markedly from each other with respect to interpretation of the test result and to clarity of the test performance. Increasing the read time of the QuikStrip device from 5 to 30 min resulted in an increase in false-negative test results. CONCLUSIONS: Our results indicate that special care should be taken when selecting immunology-based point-of-care methods for measurement of buprenorphine.