Performance Evaluation of the MyT4 Technology for Determining ART Eligibility

PLoS One. 2016 Oct 25;11(10):e0165163. doi: 10.1371/journal.pone.0165163. eCollection 2016.

Abstract

Background: In resource-limited countries, CD4 T-cell (CD4) testing continues to be used for determining antiretroviral therapy (ART) initiation eligibility and opportunistic infection monitoring. To support expanded access to CD4 testing, simple and robust technologies are necessary. We conducted this study to evaluate the performance of a new Point-of-Care (POC) CD4 technology, the MyT4, compared to conventional laboratory CD4 testing.

Methods: EDTA venous blood from 200 HIV-positive patients was tested in the laboratory using the MyT4 and BD FACSCalibur™.

Results: The MyT4 had an r2 of 0.82 and a mean bias of 12.3 cells/μl. The MyT4 had total misclassifications of 14.7% and 8.8% when analyzed using ART eligibility thresholds of 350 and 500 cells/μl, respectively.

Conclusions: We conclude that the MyT4 performed well in classifying patients using the current ART initiation eligibility thresholds in Mozambique when compared to the conventional CD4 technology.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • CD4 Lymphocyte Count / instrumentation*
  • Child
  • Child, Preschool
  • Cross-Sectional Studies
  • Eligibility Determination
  • Female
  • HIV Infections / immunology*
  • HIV Seropositivity
  • Humans
  • Male
  • Middle Aged
  • Mozambique
  • Point-of-Care Systems
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Young Adult

Grants and funding

The authors are grateful to UNITAID and DFID for providing financial support for staff and operational costs of this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.