• Article

Use of external quality control material for HIV-1 RNA testing to assess the comparability of data generated in separate laboratories and the stability of HIV-1 RNA in samples after prolonged storage

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Jennings, C., Wager, C. G., Scianna, S. R., Zaccaro, D. J., Couzens, A., Mellors, J. W., ... Bremer, J. W. (2018). Use of external quality control material for HIV-1 RNA testing to assess the comparability of data generated in separate laboratories and the stability of HIV-1 RNA in samples after prolonged storage. Journal of Clinical Microbiology. DOI: 10.1128/JCM.00120-18

The NIAID AIDS Clinical Trials Group (ACTG) stores specimens from their clinical trials in a biorepository and permits the use of these specimens for non-protocol exploratory studies once the studies for the original protocol are concluded. We sought to assess the comparability of data generated for real-time HIV-1 RNA testing during two clinical trials with data generated from retesting of different aliquots of the same samples after years of storage at -80° C. Overall, there was 92% agreement in the data for 1570 paired samples (Kappa statistic = 0.757 [0.716-0.797]) generated in one laboratory using the Roche HIV-1 Monitor Test, microwell plate (MWP) version where samples were tested within 1-37 days of collection, and retested in another laboratory after a median of 6.7 years of storage (5.7-8.6) using the COBAS version of the assay. Historical external control data submitted to the NIAID Virology Quality Assurance (VQA) program by client laboratories using the same two versions of the Monitor assay were used to differentiate between systematic assay differences to evaluate the stability of HIV-1 RNA in the stored samples. No significant loss of RNA was noted in samples containing either low (<50 copies/mL) or high (≥50 copies/mL) concentration of HIV-1 RNA (p=0.10 and p=0.90, respectively) regardless of the time in storage. These data confirm the quality of the plasma samples in the ACTG biorepository following long-term storage.