Performance of the Abbott RealTime™ HIV-1 assay for quantification of HIV-1 clades prevalent in China

Objective: To evaluate the performance of the Abbott RealTime(TM) HIV-1 assay for measuring viral loads of the prevalent HIV-1 clades in China. Study design: Serially diluted samples, as well as 521 clinical samples from 213 untreated HIV-1-infected individuals, 56 HIV-1-infected patients receiving ART, 60 HCV- and 57 HBV-infected patients and 135 healthy blood donors, were tested with RealTime(TM) and EaSyQ(TM). Results: Both assays exhibited linearity coefficients of >0.98. RealTime(TM) and EasyQ(TM) detected HIV-1 RNA in 87.36% and 86.99% of 269 HIV-1-seropositive samples, respectively. The correlation coefficients between the two assays for quantifying HIV-1 clades B', BC and AE were 0.884, 0.813 and 0.881, respectively, and the mean differences between the two assays for clades B', BC and AE were -0.087, 0.314 and 0.559 log(10) IU/mL, respectively. The correlation coefficient between the two assays for measuring samples from patients receiving ART was 0.945 (mean difference, 0.085 log(10) IU/mL). No false-positive samples were found among the 60 HCV-infected patients, 57 HBV-infected patients and 135 healthy blood donors. Conclusions: The Abbott RealTime(TM) HIV-1 assay shows good linearity and specificity. ART drugs and HIV-1 clades B' and BC do not affect the performance of the assay. However, clade AE may be less readily detected. (C) 2008 Elsevier B.V. All rights reserved.