title: Evaluation of PIMA point-of-care CD4 analyzer in Yunnan, China.
abstract: BACKGROUND
  CD4 count is used to determine antiretroviral therapy (ART) eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance of Alere PIMA point-of-care CD4 analyzer.
  
  
  METHODS
  Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference.
  
  
  RESULTS
  Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of - 47.0 cells/μl (limit of agreement, [LOA]: -204-110 cells/μl) for venous blood and -71.0 cells/μl (LOA: -295-153 cells/μl) for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value (PPV) of PIMA was 84.2% and 75.7% and the negative predictive value (NPV) was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively.
  
  
  CONCLUSIONS
  CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.
authors.forename: Jun
authors.initials: J
authors.lastname: Liang
authors.forename: Song
authors.initials: S
authors.lastname: Duan
authors.forename: Yan-Ling
authors.initials: YL
authors.lastname: Ma
authors.forename: Ji-Bao
authors.initials: JB
authors.lastname: Wang
authors.forename: Ying-Zhen
authors.initials: YZ
authors.lastname: Su
authors.forename: Hui
authors.initials: H
authors.lastname: Zhang
authors.forename: Chin-Yih
authors.initials: CY
authors.lastname: Ou
authors.forename: Ling
authors.initials: L
authors.lastname: Hao
authors.forename: Ming-Shan
authors.initials: MS
authors.lastname: Qi
authors.forename: Marc
authors.initials: M
authors.lastname: Bulterys
authors.forename: Larry
authors.initials: L
authors.lastname: Westerman
authors.forename: Yan
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Department of AIDS/STD Prevention, National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Xiao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001681:Biological Assay / Q000379:methods*; D001800:Blood Specimen Collection; D018791:CD4 Lymphocyte Count / Q000379:methods*; D002648:Child; D002681:China; D005260:Female; D015658:HIV Infections / Q000175:diagnosis; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D055815:Young Adult
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