摘要
目的比较和评价国产流式细胞仪检测CD4^(+)T淋巴细胞的准确性和重复性。方法分别用3种流式细胞仪对200例HIV/AIDS患者样本做平行检测,并选取CD4高值、低值的样本各20例,以及BC公司的全血质控品在CytoPOC、CytoFOCUS机型上做重复性试验。使用SPSS 20.0软件和MedCale软件进行t检验、Pearson相关分析和一般线性回归分析,采用Bland-Altman法进行一致性分析,P<0.05为差异有统计学意义。结果3种机型对200例HIV/AIDS患者样本的T淋巴细胞亚群检测结果的差异无统计学意义(P>0.05)。BD与CytoPOC、BD与CytoFOCUS、CytoPOC与CytoFOCUS相关系数(r)分别为0.98、0.98、0.99,3种机型CD4细胞绝对数具有显著相关性(P<0.001),将CD4细胞绝对数按≥500细胞/μl、200~499细胞/μl、<200细胞/μl分层进行相关性分析,各个分层的结果均显著相关(P<0.0001)。Bland-Altman分析显示,BD和CytoPOC、CytoFOCUS的平均差异分别为28.768个/μl(95%CI:22.0769~35.4591)、19.2461个/μl(95%CI:12.3097~26.1825),CytoPOC和CytoFOCUS的平均差异为-9.5219个/μl(95%CI:-13.7976~-5.2462),3种机型一致性较好。按上述分层比较,各个分层3种机型的CD4细胞绝对数均有较好的一致性,但随着CD4绝对计数的增大,2种国产机型与BD之间的平均差异均升高;CytoPOC、CytoFOCUS机型对CD4高值、低值样本以及BC全血质控品的检测结果CV值均小于8%,符合行业标准。结论CytoPOC和CytoFOCUS流式细胞仪对CD4^(+)T淋巴细胞检测结果与BD相关性和一致性较高,且重复性较好。
Objective To compare and evaluate the accuracy and repeatability of two types of domestic flow cytometry(CytoPOC and CytoFOCUS)for detection of CD4^(+)T lymphocytes.Methods Three types of flow cytometry were used to parallel testing of 200 samples with different reagents from HIV/AIDS.20 samples with high and 20 samples with low CD4 value and Immuno-Trol Cells of BC company were detected by CytoPOC and CytoFOCUS flow cytometry to do a repeatability test SPSS 20.0 and MedCale software were used for t test,Pearson correlation analysis and genera linear regression analysis,and Bland-Altman method consistency analysis were conducted,and P0.05).The comparison of CD4^(+)T lymphocyte counts obtained by three types of flow cytometry resulted in a Pearson correlation coefficients:0.98,0.98 and 0.99,respectively,the results were significantly correlated(P<0.001).The CD4^(+)T lymphocyte absolute counts stratified into≥500 cells/μl,200~499 cells/μl and<200 cells/μl layers,and the three flow cytometries were significantly correlated(P<0.0001).Bland-altman analysis showed that BD had a mean difference of 28.768cells/μl(95%CI:22.0769~35.4591)compared to the CytoPOC,a mean difference of 19.2461/μl(95%CI:12.3097~26.1825)compared to the CytoFOCUS.CytoPOC had a mean difference of-9.5219 cells/μl(95%CI:-13.7976~-5.2462)compared to the CytoFOCUS.According to the stratification,the CD4^(+)T lymphocyte absolute counts of the three types of flow cytometries in each layer were consistent,but the mean difference between BD and the two types of domestic flow cytometries increasing with the increase of CD4^(+)T lymphocyte absolute counts.The test result of CV values of CytoPOC and CytoFOCUS for high and low CD4 samples and Immuno-Trol Cells of BC were all less than 8%,they were consistent with the industry standard.Conclusions The CD4^(+)T lymphocyte absolute counts detected by CytoPOC and CytoFOCUS flow cytometries show high correlation and consistency with BD,and the repeatability is good.
作者
张燕
周更生
袁丹
梁姝
ZHANG Yan;ZHOU Geng-sheng;YUAN Dan;LIANG Shu(Sichuan Center for Disease Control and Prevention,Chengdu 610041,Sichuan Province,China)
出处
《预防医学情报杂志》
CAS
2022年第8期1158-1163,共6页
Journal of Preventive Medicine Information
基金
四川省卫健委科研课题(项目编号:20PJ121)。
