WS 293—2019《艾滋病和艾滋病病毒感染诊断》中HIV抗体确证结果判定标准的临床应用  

Clinical use of determination criteria for HIV antibody confirmatory results in WS 293-2019 Diagnosis for HIV/AIDS

作　　者：赖专华[1] 严钏元[1] 杨丽华 徐冰 张瑜兰[3] 邢文革[2] LAI Zhuan-hua;YAN Chuan-yuan;YANG Li-hua;XU Bing;ZHANG Yu-lan;XING Wen-ge(Clinical Laboratory,Baoji Center for Disease Control and Prevention,Baoji Shaanxi,712006,China;National Center for AIDS/STD Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing,102206,China;Clinical Laboratory,Baoji Center Hospital,Baoji Shaanxi,721008,China)

机构地区：[1]宝鸡市疾病预防控制中心检验科,陕西宝鸡721006 [2]中国疾病预防控制中心性病艾滋病预防控制中心,北京102206 [3]宝鸡市中心医院检验科,陕西宝鸡721008

出　　处：《职业与健康》2022年第2期157-161,共5页Occupation and Health

基　　金：宝鸡市卫健委课题(2019-51)。

摘　　要：目的 探讨WS 293—2019《艾滋病和艾滋病感染诊断》(简称《19版行标》)中人类免疫缺陷病毒(humon inmunode ficiency virus,HIV)抗体确证试验结果中两条HIV-1抗体阳性平行判定标准的差异,为艾滋病的精准检测诊断提供技术支持。方法 利用2011—2019年宝鸡市艾滋病确证实验室1 515例HIV抗体蛋白印迹试验(western blot,WB)结果,按照《19版行标》中HIV-1抗体阳性确证第1条和第2条判定标准进行结果判定,了解两条判定标准在HIV抗体确证结果判定的差异。结果 1 515例《19版行标》第1条与第2条判定标准判定结果之间的差异有统计学意义(χ^(2)=8.556,P=0.014);第1条与第2条判定标准判定总符合率为96.6%。40例按照《19版行标》第1条HIV-1抗体阳性标准判定为阳性样本中,有26例判定为阳性为正确判定,有14例误判为阳性。26例正确判定为阳性样本中,复检酶免法S/CO比值≥10占53.8%;gp160、p24、gp120出现频率较高。14例误判为阳性样本中,复检酶免法S/CO比值在1~2和≥10占比高;gp160、p24、gp 120和p66出现频率较高。14例非HIV感染者免疫印迹试验假阳性结果中有6例(WB带型为gp160,gp120,p24、gp160,p24、gp160,p17和gp120,p17)经过长期随访和回顾性的核酸定量检测,发现随访结果的条带减少和未检出核酸而被判为阴性;5例(WB带型为gp160,gp120,p24和gp160,p24)经过回顾性的血清学核酸定量检测发现均为未检出核酸而被判为阴性;3例(WB带型为gp160,p66和gp120,p66)经过4~12周的随访由于条带的减少而被判为阴性。结论 《19版行标》HIV-1抗体阳性判定符合率很高,尤其是其中第1条HIV-1抗体阳性标准的放宽更有利于早期发现患者、治疗患者以及控制HIV病毒的进一步传播,但也易出现非HIV感染者误判为阳性结果的情况。Objective To explore the differences between the two parallel determination criteria for the human immunodeficiency virus(HIV) antibody confirmatory results in WS 293-2019 Diagnosis for HIV/AIDS(hereinafter referred to as the Standard-19),which is for HIV-1 positive antibody,provide technical support for accurate HIV prevention and control. Methods By using the Western blotting(WB) test results of HIV antibody in 1 515 cases from the AIDS confirmation laboratory of Baoji City from 2011-2019,the results were determined by the Article 1 and Article 2 criteria of HIV-1 antibody confirmatory in Standard-19,to understand the differences in HIV antibody confirmatory results between the two criteria. Results Among 1 515 cases,there were statistically significant differences in the confirmatory results between the Article 1 and Article 2 criteria of the Standard-19(χ^(2)=8.556,P =0.014). The coincidence rate of the outcomes following Article 1 and Article 2 criteria was 96.6%. Among 40 positive cases which are determined by Article 1 criteria of the Standard-19,26 cases were correct outcome,yet 14 cases were false. Among the 26 positive cases with correct outcome,53.8% had the S/CO value ≥10 in the re-inspection by ELISA,and gp160,p24 and gp120 appeared frequently. Among the 14 false-positive cases,the proportions of the S/CO value was 1-2 and ≥10 in the re-inspection by ELISA were higher,and gp160,p24,gp 120 and p66 appeared frequently. Among 14 cases with false positive result in WB test from non-HIV infections,6 cases(WB bands were gp160,gp120,p24,gp160,p24,gp160,p17 and gp120,p17)were determined as negative cases due to reduced bands and nucleic acid was not detected in long-term follow-up and retrospective nucleic acid quantitative testing,5 cases(WB bands were gp160,gp120,p24 and gp160,p24) were determined as negative cases due to nucleic acid was not detected in the retrospective serological nucleic acid quantitative testing,and 3 cases(WB bands were gp160,p66 and gp120,p66) were determined as negative cases

关 键 词：人类免疫缺陷病毒 艾滋病 蛋白免疫印迹试验 标准 

分 类 号：R446.6[医药卫生—诊断学]