干血斑HIV-1核酸定性检测的可靠性研究  

Reliability of the result for HIV-1 qualitative nucleic acid test based on dried blood spots

作　　者：姚佳明 陈文先[2] 潘晓红[1] 郭志宏[1] 丁晓贝[1] 范钦[1] 夏燕[1] 张佳峰[1] YAO Jiaming;CHEN Wenxian;PAN Xiaohong;GUO Zhihong;DING Xiaobei;FAN Qin;XIA Yan;ZHANG Jiafeng(Department of HIV/AIDS&STD Control and Prevention,Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou 310051,China;Microbiological laboratory,Yiwu Municipal Center for Disease Control and Prevention,Yiwu 322000)

机构地区：[1]浙江省疾病预防控制中心艾滋病与性病预防控制所,杭州310051 [2]义乌市疾病预防控制中心微生物检验科,浙江义乌322000

出　　处：《中国艾滋病性病》2021年第5期446-449,共4页Chinese Journal of Aids & STD

基　　金：国家“十三五”科技重大专项(2017ZX10201101)。

摘　　要：目的探索干血斑(DBS)核酸定性检测用于HIV-1感染诊断的可靠性。方法同步采集参加自愿咨询检测人员的DBS样本和配套血清样本各230份,DBS样本用于HIV-1核酸定性检测,血清样本进行常规抗体检测,分析比较两种方法的检测结果。结果DBS初次核酸定性结果与血清初次抗体检测结果一致率为98.70%,Kappa值为0.93,经复核及随访复检后两种方法最终判断结果完全一致,一致率为100%。其中2例抗体不确定样本其核酸定性检测为阳性,随访后WB条带进展,确证为HIV-1抗体阳性;有1例抗体阴性样本其首次核酸定性检测为阳性,双份复核为阴性。结论DBS核酸定性结果与常规血液抗体检测的感染诊断结果一致性好,且流程简便、准确性高,但需考虑不确定范围。Objective To investigate the reliability of HIV-1 qualitative nucleic acid test using dried blood spots(DBS)to diagnose HIV-1 infection.Methods DBS samples and paired serum samples were collected synchronously from 230 voluntary attendees seeking counselling and testing.The DBS samples were used for the HIV-1 qualitative nucleic acid test,and the serum samples were used for routine antibody detection.The results of the two methods were analyzed and compared.Results The concordant rate of first test results between HIV-1 qualitative nucleic acid test using dried blood spots and paired serum antibody test was 98.70%,and the Kappa value was 0.93.After check and follow-up reexamination,the two methods’final judgment results were entirely consistent,with a constant rate of 100%.Two samples with indeterminate Western blotting(WB)results were initially tested positive in HIV-1 qualitative nucleic acid assay.These two samples were confirmed to be HIV-1 antibody positive after follow-up,with WB banding patterns progressed.With serum antibody negative,another sample was initially tested positive in HIV-1 qualitative nucleic acid assay but found negative in the two parallel samples’reexamination.Conclusion The HIV-1 qualitative nucleic acid test using DBS is consistent with those of routine blood antibody tests to diagnose HIV-1 infection.It is characterized by simple Process and high accuracy,but the uncertainty range should be taken into account.

关 键 词：艾滋病病毒 干血斑 核酸检测 抗体检测 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]