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Activity Number: 699
Type: Contributed
Date/Time: Thursday, August 4, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #320980 View Presentation
Title: HIV kit lot related shifts in RNA using external control samples: the Virology Quality Assurance Program
Author(s): Daniel Zaccaro* and Amy Couzens and Donald Brambilla and Cheryl Jennings and James Bremer
Companies: RTI International and RTI International and RTI International and Rush University Medical Center and Rush University Medical Center
Keywords: Proficiency testing ; HIV RNA ; variance components

The Virology Quality Assurance (VQA) program monitors HIV-1 RNA assay performance to promote comparability of measurements in clinical studies of HIV treatments. Periodically, laboratories are challenged with test panels prepared at the VQA Laboratory to assess assay performance. Analysis of data generated from recent test panels showed a downward shift in mean HIV RNA measurements of -0.2 log10 (37%) using the TaqMan platform. The absence of a similar shift on the Abbott platform and the association of the shift with specific kit lots is currently being evaluated by the manufacturer and not a laboratory performance problem. We also observed departures from the expected linear relationship between measured and expected RNA titer during the last several years of testing. These observations highlight the importance of quality assurance programs with periodic testing of well-characterized samples for proficiency and external run control, not only for monitoring assay performance within a laboratory but also for evaluating cross-platform assay performance to detect kit-related shifts that exceed the bounds of normal variation in HIV RNA results.

Authors who are presenting talks have a * after their name.

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