一种新的干粉试剂盒检测艾滋病患者CD4细胞绝对计数和百分比的效果  

Evaluation of a new dry format reagent for CD4 absolute count and percentage test for HIV/AIDS patients

作　　者：杨朝军[1] 董莉娟[1] 戴洁[1] 陈会超[1] 陈敏[1] 杨莉[1] 马艳玲[1] 

机构地区：[1]云南省疾病预防控制中心性病艾滋病防制所,云南昆明650022

出　　处：《现代预防医学》2017年第18期3385-3389,共5页Modern Preventive Medicine

基　　金：中美艾滋病防治合作项目(GAP项目)

摘　　要：目的评价美国Beckman Coulter公司(BC公司)的三色荧光抗体干粉试剂(CD3/CD4/CD8)在流式细胞仪上检测CD4细胞计数及CD4细胞百分比的准确性。方法于2015年12月开始在云南省疾病预防控制中心收集艾滋病自愿咨询检测(VCT)门诊的血液样本和送检样本共计201份,分别用美国的Becton Dickinson公司(BD公司)的液态三色荧光抗体试剂和BC公司的干粉试剂进行样本处理,使用BD FACSCalibur流式细胞仪和Multiset软件程序进行CD4细胞绝对计数和百分比分析,用SPSS软件和Bland-Altman图对2种试剂检测结果的一致性进行分析。结果 BC和BD试剂对201例样本的CD4细胞计数的均值分别为(506.3±605.3)个/μl(10~2 458)和(501.0±610.3)个/μl(7~2 406),Pearson相关系数为0.984,平均偏差为+5.3个/μl(95%CI:-102.3~113.0);CD4细胞百分比的结果具有很好的相关性,Pearson相关系数为0.992,平均偏差为+0.66%(95%CI:-3.6%~4.9%)。以CD4细胞计数等于350个/μl为治疗阈值,BC干粉试剂的敏感性和特异性分别为95.8%和98.4%。结论与BD试剂相比,BC干粉试剂在FACSCalibur流式细胞仪上检测CD4细胞的绝对数和百分比具有较好的相关性和一致性,干粉试剂的保存和运输无需冷链,适合基层单位推广应用。Objective To evaluate the quality of triad-color fluorescence labelled antibodies dry format reagent from Beckman Coulter（BC） for detecting the count and percentage of CD4. Methods A total of 201 blood samples and submitted samples were collected from Yunnan CDC HIV/AIDS voluntary counseling and testing（VCT） clinic starting on December 2015. All of the samples were used to analyze the absolute count and percentage of CD4 by BD FACSCalibur flow cytometer and Multiset software with BC and BD reagent kits. The data was processed with SPSS and analyzed with Bland-Altman chart to compare the correlation coefficient and consistency of the two methods. Results The absolute CD4 counts from 201 samples were 506.3 ±605.3 cells/μl（range 10 ~2458） by BC reagent and 501.0 ±610.3 cells/μl（range 7 ~2406） by BD reagent. The Pearson correlation coefficient was 0.984 and the mean bias was ＋5.3 cells/μl（95%CI：-102.3~113.0）. For CD4 percentage the Pearson correlation coefficient was 0.992 and the mean bias was ＋0.66%（95%CI：-3.6%~4.9%）. Using the threshold of 350 cells//μl as ART treatment initiation, the sensitivity and specificity of BC dry reagent were 95.8% and 98.4% respectively. Conclusion Compares with BD reference reagen, BC dry format reagent applied in FACSCalibur had a good correlation between the absolute count and percentage levels of CD4. The BC dry format reagent is suitable for remote units without cold chain facilities.

关 键 词：HIV CD4淋巴细胞 干粉试剂 质量评估 

分 类 号：R183[医药卫生—流行病学]