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Comprehensive &amp; Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
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Published on: October 31, 2010

Performance comparison of CD4 T-cell count instruments based on data from the national proficiency testing program in

Hui Zhang1, Haifeng Ding1, Pei Liu1

  • 1National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.

BMC Infectious Diseases
|May 27, 2026
PubMed
Summary

CD4 T-cell counts are vital for HIV monitoring. This study found that 10 mainstream CD4 instruments in China perform comparably, meeting laboratory needs for accurate immune status assessment.

Keywords:
CD4 T-cell countHIVProficiency testing

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Area of Science:

  • Clinical immunology
  • Medical diagnostics
  • HIV/AIDS research

Background:

  • CD4 T-cell counts are critical biomarkers for assessing immune status in people living with HIV (PWH).
  • A growing number of CD4 count instruments are approved in China, necessitating performance evaluation.
  • No systematic comparisons of these instruments' performance have been published.

Purpose of the Study:

  • To systematically compare the performance of 10 mainstream CD4 count instruments used in China.
  • To evaluate the agreement and interchangeability of CD4 test results across different instruments.
  • To assess the suitability of these instruments for HIV testing laboratories.

Main Methods:

  • Retrospective analysis of national proficiency testing data (2016-2023).
  • Comparative performance evaluation of 10 CD4 count instruments.
  • Statistical analysis using Passing-Bablok regression and mixed-effects models.

Main Results:

  • Increasing use of Chinese-manufactured and point-of-care CD4 testing instruments observed.
  • All 10 instruments showed strong correlations (R²: 0.952–0.983) and agreement with target values.
  • Eight instruments showed significantly lower values than the reference, but remained within acceptable ranges.

Conclusions:

  • Commonly used CD4 count instruments demonstrate comparable performance.
  • The evaluated instruments are suitable for meeting the demands of HIV testing laboratories.
  • Continued monitoring and comparison of CD4 testing technologies are important for quality assurance.