Performance of a novel viral load assay for plasma HIV-1 RNA quantification compared with Roche real time PCR in China.

The aim of this study was to compare the Sansure HIV-1 VL assay with the Roche Cobas HIV-1 assay in the quantitation of HIV-1 VL and evaluate its application in China. We collected plasma samples from patients infected with HIV-1 or interference patients infected with other viruses. The same samples were subsequently tested using the Sansure HIV-1 VL and Roche Cobas HIV-1 VL assays. Thirty plasma samples from patients not infected with HIV-1 were undetectable using two assays. Overall, agreement was observed for 289 of the 300 samples (96.33 %), with a κ value of 0.92. The Pearson correlation coefficient between the two assays was 0.96. A paired t test revealed no significant difference between the two assays (p = 0.64). Bland-Altman analysis revealed that 97.88 % (185/189) of the paired VLs fell within the 95 % confidence limits of agreement (-0.746-0.768 log10 copies/mL). In particular, the Pearson correlation coefficients for the samples of subtypes CRF01_AE, CRF07_BC, CRF08_BC, and CRF55_01B were 0.98, 0.97, 0.99, and 0.98, respectively. Compared with the Roche Cobas HIV-1 assay, the Sansure HIV-1 VL assay showed good accuracy and linearity and a high correlation, including with HIV subtypes common in China. In addition, the Sansure HIV-1 VL assay is more accessible because of its advantages of price, acquisition and suitability; thus, it can be readily used in China.