title: Performance of the Abbott RealTime HIV-1 assay for quantification of HIV-1 clades prevalent in China.
abstract: 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]
authors.affiliation: Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, No. 2 Tiantanxi, Beijing 100050, PR China.
authors.forename: Sihong
authors.initials: S
authors.lastname: Xu
authors.forename: Aijing
authors.initials: A
authors.lastname: Song
authors.forename: Xiuhua
authors.initials: X
authors.lastname: Li
authors.forename: Jingyun
authors.initials: J
authors.lastname: Li
authors.forename: Zuoyi
authors.initials: Z
authors.lastname: Bao
authors.forename: Panyong
authors.initials: P
authors.lastname: Mao
authors.forename: Qing
authors.initials: Q
authors.lastname: Zhao
authors.forename: Youchun
authors.initials: Y
authors.lastname: Wang
mesh_terms: 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*