BMC infectious diseases · 2026
Performance comparison of CD4 T-cell count instruments based on data from the national proficiency testing program in China, 2016-2023.
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Zhang Hui, Ding Haifeng, Liu Pei, Wang Meilin, Zhu Qiyu, Zhang Xin, Ding Mengjun, Liu Fangfang, Niu Mingzhu, Jin Cong
Аннотация
BACKGROUND: The number of CD4 T cells is an important indicator of immune status in people living with HIV (PWH). In China, numerous CD4 count instruments have been approved; however, no studies have been conducted to systematically compare the performance of these instruments.
METHODS: We retrospectively analyzed data from the national proficiency testing program for CD4 T-cell counts in China from 2016 to 2023. We conducted comparative analysis to evaluate the performance of 10 mainstream CD4 count instruments. Passing-Bablok regression and mix-effects model analyses were used to analyze the agreement and interchangeability of test results among instruments.
RESULTS: The proportion of laboratories participating in the CD4 proficiency testing program and using Chinese-manufactured and point-of-care testing instruments has increased annually, from 4.7% to 29.7% and from 3.3% to 8.1%, respectively. The results of the 10 devices tested showed strong correlations and agreement with target values, with correlation coefficients (R²) ranging from 0.952 to 0.983 and with the mean bias ranged from -1 to + 95 cells/µL across the 10 devices. Strong agreement was observed among the results for the 10 instruments, slopes ranged from 0.866 to 1.214, while the intercepts varied from -42.3 cells/µL to + 24.0 cells/µL. After adjusting for sample and laboratory effects using a linear mixed-effects model, eight instruments (B, C, D, M, J, FP, LP, H) produced significantly lower values than the reference instrument A (adjusted mean = 613.0; differences: -92.0 to -20.3; all p < 0.05). Tukey-adjusted pairwise comparisons identified H, LP, and FP as a distinct low-value subgroup, although their measurements remained within the acceptable range.
CONCLUSIONS: The performance of commonly used CD4 count instruments was comparable and can meet the needs of HIV testing laboratories.
CLINICAL TRIAL: Not applicable.
METHODS: We retrospectively analyzed data from the national proficiency testing program for CD4 T-cell counts in China from 2016 to 2023. We conducted comparative analysis to evaluate the performance of 10 mainstream CD4 count instruments. Passing-Bablok regression and mix-effects model analyses were used to analyze the agreement and interchangeability of test results among instruments.
RESULTS: The proportion of laboratories participating in the CD4 proficiency testing program and using Chinese-manufactured and point-of-care testing instruments has increased annually, from 4.7% to 29.7% and from 3.3% to 8.1%, respectively. The results of the 10 devices tested showed strong correlations and agreement with target values, with correlation coefficients (R²) ranging from 0.952 to 0.983 and with the mean bias ranged from -1 to + 95 cells/µL across the 10 devices. Strong agreement was observed among the results for the 10 instruments, slopes ranged from 0.866 to 1.214, while the intercepts varied from -42.3 cells/µL to + 24.0 cells/µL. After adjusting for sample and laboratory effects using a linear mixed-effects model, eight instruments (B, C, D, M, J, FP, LP, H) produced significantly lower values than the reference instrument A (adjusted mean = 613.0; differences: -92.0 to -20.3; all p < 0.05). Tukey-adjusted pairwise comparisons identified H, LP, and FP as a distinct low-value subgroup, although their measurements remained within the acceptable range.
CONCLUSIONS: The performance of commonly used CD4 count instruments was comparable and can meet the needs of HIV testing laboratories.
CLINICAL TRIAL: Not applicable.