A Comparative Study of CD4+ T-lymphocyte Counts between Alere PIMA CD4 Point-of-Care and Standard Flow Cytometry Methods

Prakit Yothipitak, Duangporn Wiwattanasorn, Sart Somboon, Sai Nothawian

Abstract


Alere PIMA CD4 is a new Point-of-Care (POC) technology for CD4+ T- lymphocytes counting. The aim of this study was to evaluate the testing performance of the Alere PIMA CD4 analyzer performed at hospital laboratory level compared with the standard flow cytometry method. A total of 300 EDTA blood samples from each 100 HIV infected patients obtained from Chonburi Hospital, Banglamoong Hos- pital and Ao-Udom Sriracha Hospital were recruited in this study. Absolute CD4+ T-lymphocyte counts were conducted on the same day of sample collection using Alere PIMA CD4 analyzers at each site and the standard immunostaining from flow cytometer using BD TriTest method by BD FACSCalibur at one site, Chonburi Hos- pital. Data analysis of test results of Alere PIMA CD4 gave an excellent correlation with the standard method (r > 0.95). Bland – Altman plots also revealed low biases obtained from Alere PIMA CD4 analyzer compared to the standard flow cytometer at Chonburi and Ao-Udom Sriracha Hospitals as average - 6.8 and - 12 cells/mm3, respectively, whereas higher numbers of CD4 cells were obtained at Banglamoong Hospital as average 31.4 cells/mm3. Conclusively, the Alere PIMA analyzer can be an alternative Point-of-Care for absolute CD4+ T-lymphocyte counts at trial sites with only 20-30 minutes turnaround time for each sample. However, the competency of laboratory personnel and appropriate quality control should be carefully considered.

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