便携淋巴细胞仪检测艾滋病患者静脉及末梢血的性能评价

Objective To evaluate the performance of Pima Analyser portable induced T cell(CD4+ T cell) assay in the determination of CD4 cell counts in venous and peripheral blood of patients with human immunodeficiency virus(HIV) infection/acquired immune deficiency syndrome(AIDS). Methods Venous blood and fingertip peripheral blood samples from 334 HIV-infected individuals/patients collected by the Qingzhen Center for Disease Control and Prevention from January 2023 to July 2025 were selected. CD4 cell counts were detected using the Pima Analyser portable device and the traditional flow cytometer respectively, and the results detected by the flow cytometer were taken as the gold standard. The paired t-test, Bland-Altman method and kappa test were used to compare the differences and consistencies between the Pima Analyser instrument and the gold standard test results. Results There was no statistically significant difference in the CD4 cell counts of venous blood and peripheral blood detected by the Pima Analyser detector compared with the gold standard results(P>0.05). There was no significant difference(P>0.05) in the stratification results of CD4 cell count between venous blood and capillary blood detected by the Pima Analyser detector and the gold standard. Among the two detection methods, the proportion of CD4 cell count ≤200 cells/μL was the highest in both venous blood and capillary blood, and the proportion>500 cells/μL was the lowest. Bland-Altman analysis showed that the mean biases of the two test methods in venous blood and capillary blood were 1.25(-48.91～51.41) cells/μL and 1.11(-53.19～55.41) cells/μL, respectively. At the threshold of CD4 cell<350 cells/μL, the accuracy and specificity of Pima Analyser in detecting venous blood and capillary blood were 95.81%, 90.91% and 97.90%, 95.65%, respectively. Conclusion The Pima Analyser detection showned no statistically significant difference from the gold standard in the determination of CD4 cell count in venous blood and capillary blood. The clinical stratification was consistent, the deviation was small, and the accuracy was high when CD4 cell was less than 350 cells/μL. It is suitable for rapid clinical detection.