Pilot validation study of the PIMA portatil platform for the CD4 T-cell enumeration compared to flux cytometry

Abstract

Objective: To compare PIMA methodology to the standard CD4 FACSCalibur flow cytometry for CD4 testing.
Method: Paired blood samples were collectedamong HIV patients and tested using PIMA and Becton Dickinson FACSCalibur.
Results: 223 samples were studied in parallel. There was a high concordance, being Pearson Linear Correlation 0.974, the Spearman Rank Correlation Coefficient 0.971. The Intraclass Correlation Coefficient for individual measures was 0.965 (95%CI 0.926-0.980) and for average measures 0.982 (95%CI 0.961-0.990). There was a low coefficient of variation from duplicate measurements (11.4%).
Conclusion: This study shows a good correlation between the PIMA CD4 count and the Becton Dickinson FACSCalibur. By being a point of care methodology that produces same-day results, PIMA CD4 might be an alternative for sites without access to standard CD4 count methodology.