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 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 and EasyQ. RESULTS: Both assays exhibited linearity coefficients of >0.98. RealTime and EasyQt 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 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. Based on the comparison data, [corrected] clade AE may be more [corrected] readily detected by using this method [corrected]