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The study aims to evaluate the analytical performance of the VITA™ point-of-care CD4 assay compared to conventional flow cytometry.

May 4, 2026

Analytical performance of the VITA™ point-of-care CD4 enumeration assay.

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Randomized trial evaluates VITA™ CD4 assay performance versus AQUIOS flow cytometry in HIV management, indicating strong correlation.

The study aims to evaluate the analytical performance of the VITA™ point-of-care CD4 assay compared to conventional flow cytometry.
Evaluated VITA™ CD4 using remnant blood samples from people with HIV with known CD4 counts on AQUIOS flow cytometry.
Performed statistical analyses including correlation analysis and Bland-Altman agreement analysis.
Calculated coefficient of variation on duplicate measurements.
VITA™ CD4 had a strong correlation with AQUIOS flow cytometry (r = 0.973, p < 0.001).
Mean bias in Bland-Altman analysis was -48.9 cells/μl (95% CI: -61.8 to -36.0) with clinical implications for different CD4 counts.
Coefficient of variation for duplicate measurements was 11.86%.

Ong et al. (2026) studied this question.

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