Publications by authors named "Leah Sakai"

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Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System.

Sex Transm Dis 2020 05;47(5S Suppl 1):S32-S34

Medical and Scientific Affairs, Roche Molecular Systems, Pleasanton, CA.

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.
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May 2020