Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System.
| Autor: | Rodriguez PL; From the Medical and Scientific Affairs., McCune S; From the Medical and Scientific Affairs., Sakai L; Commercial Education, Roche Diagnostics Corporation, Indianapolis, IN., Engstrom-Melnyk J; From the Medical and Scientific Affairs., Marins E; Medical and Scientific Affairs, Roche Molecular Systems, Pleasanton, CA. |
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| Jazyk: | angličtina |
| Zdroj: | Sexually transmitted diseases [Sex Transm Dis] 2020 May; Vol. 47 (5S Suppl 1), pp. S32-S34. |
| DOI: | 10.1097/OLQ.0000000000001125 |
| Abstrakt: | Background: Diagnosis of HCV, HBV, and HIV involves antibody screening followed by confirmation and/or treatment decision using nucleic acid tests. However, minimal data exist evaluating the risk of nucleic acid cross-contamination on serology devices upstream of molecular testing despite the potential clinical and laboratory workflow advantages of single specimen vial testing for both procedures. Methods: We conducted a checkerboard study investigating the potential risk of HCV, HBV, and HIV nucleic acid cross-contamination on 480 negative specimens by a serology screening instrument that uses disposable tips for sample transfer, rather than a fixed needle, before molecular testing. Results: Nucleic acid contamination was observed in 0 of 480 negative specimens when processed with alternating high-titer HCV, HBV, or HIV specimens on the serology platform. Conclusions: This study suggests that specimens analyzed by a serology instrument using disposable tips for sample transfer may be suitable for direct primary specimen reflex testing by a sensitive nucleic acid confirmatory test. |
| Databáze: | MEDLINE |
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