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.


METHODS
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]
Xu
Sihong
S
Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, No. 2 Tiantanxi, Beijing 100050, PR China.
Song
Aijing
A
Li
Xiuhua
X
Li
Jingyun
J
Bao
Zuoyi
Z
Mao
Panyong
P
Zhao
Qing
Q
Wang
Youchun
Y
D023241:Antiretroviral Therapy, Highly Active; D002681:China; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy / Q000821:virology*; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006509:Hepatitis B / Q000821:virology; D006526:Hepatitis C / Q000821:virology; D006801:Humans; D025202:Molecular Diagnostic Techniques; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*