This work was supported in part by the National Heart, Lung, and Blood Institute Contracts N01-HB-97077 (superseded by N01-HB-47114), -97078, -97079, -97080, -97081, and -97082 through the Retrovirus Epidemiology Donor Study. Data on plasma donor panels were provided by Alpha Therapeutic Corporation and National Genetics Institute (NGI) and testing reagents by the manufacturers of the NAT assay systems (Roche Molecular Systems and Gen-Probe Inc.).
Relative sensitivities of licensed nucleic acid amplification tests for detection of viremia in early human immunodeficiency virus and hepatitis C virus infection†
Article first published online: 18 OCT 2005
Volume 45, Issue 12, pages 1853–1863, December 2005
How to Cite
Busch, M. P., Glynn, S. A., Wright, D. J., Hirschkorn, D., Laycock, M. E., McAuley, J., Tu, Y., Giachetti, C., Gallarda, J., Heitman, J., Kleinman, S. H. and National Heart, Lung, Blood Institute Nucleic Acid Test Study Group (2005), Relative sensitivities of licensed nucleic acid amplification tests for detection of viremia in early human immunodeficiency virus and hepatitis C virus infection. Transfusion, 45: 1853–1863. doi: 10.1111/j.1537-2995.2005.00649.x
- Issue published online: 18 OCT 2005
- Article first published online: 18 OCT 2005
- Received for publication March 20, 2005; revision received May 5, 2005, and accepted May 9, 2005.
BACKGROUND: Screening donors for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) RNA is primarily performed on minipools (MPs) with one of two commercial nucleic acid amplification tests (NAT; Roche Molecular Systems; or Gen-Probe/Chiron). We compared these assays with respect to detection of RNA in early HIV and HCV infection.
STUDY DESIGN AND METHODS: Twelve HIV plasma donor panels (116 serial samples) and 12 HCV panels (180 serial samples) were selected to optimally represent early viremia. Initial testing was performed in singlicate or triplicate on separately coded aliquots, both neat and at dilutions corresponding to MP screening (1:16 for Gen-Probe; 1:24 for Roche); 20 additional replicates were performed when discordant results were observed. Odds ratios (ORs) comparing detection of RNA by different assays were derived with logistic regression models. Differences in window-period closure and yields of assays in MP or individual-donation (ID) format were estimated.
RESULTS: Differences in detection rates between Roche and Gen-Probe NAT assays were small and only observed with samples with very-low-level viremia. ORs for detecting RNA by the Gen-Probe versus the Roche assay were significant for HIV if conducted on MPs (1.8; 95% confidence interval [CI], 1.3-2.5) but not neat (1.0; 95% CI, 0.72-1.4). Odds of detecting HCV RNA were higher if the Gen-Probe assay was conducted either neat (2.3; 95% CI, 1.6-3.2) or on MPs (4.0; 95% CI, 2.8-5.8). These differences translated to <1 day window-period closure and ≤1 infection per 20 million donations. In contrast, comparisons of ID versus MP assays were highly significant for both viruses (ORs for ID vs. MP ranged from 45.3 to 93.4), with projected yields of one to two additional infections per 10 million donations.
CONCLUSIONS: Differences in sensitivities of licensed NAT assays for HIV and HCV are very small and clinically insignificant, particularly when compared to differences of MP versus ID NAT screening.