HIV血清学假阳性献血者的归队条件探究  

Investigation on the reentry conditions of blood donors with false-positive results of serological testing for HIV

作　　者：王东[1] 邓雪莲[1] 王新梅[1] 陈辉[1] 臧亮[1] 梁晓华[1] 

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2016年第1期16-20,共5页Chinese Journal of Blood Transfusion

基　　金：卫生部医药卫生科技发展研究中心专项课题(卫技中[2012]12号28-8-3)

摘　　要：目的排除HIV血清学筛查中的假阳性献血者,探讨HIV血清学反应性献血者的归队条件。方法对2013年1月1日-2015年6月30日间大连市血液中心常规血液筛查中核酸检测(NAT)无反应性、HIV血清学反应性且不被免疫印迹法(WB)确证的献血者做归队复查。复查方式同血液筛查,但血清学检测不设"灰区"。结果共筛查出HIV血清学反应性且确证阳性83例,流行率为0.43‰(83/192 065),其中第3代ELISA漏检4例(漏检率0.2/万),第4代ELISA漏检2例(漏检率0.1/万);ELISA试剂设置"灰区"的特异性低于取消"灰区"的特异性(特异性差D的95%可信区间:第3代试剂0.06‰-0.17‰,第4代试剂0.18‰-0.32‰);研究期间归队复查献血者68人,归队检测总次数为112次,单次归队复查的时间跨度为47-867(中位数194)d,单人归队的时间总跨度为89-908(中位数373)d。41人仅做了1次复查,合格率为70.73%(29/41);14人做了2次复查,合格率为57.14%(8/14);10人做了3次复查,90.00%(9/10);3人做了≥4次复查,合格率为33.33%(1/3)。归队反应性标本的确证试验全部为阴性。结论采用NAT和第4代ELISA联合检测模式同时取消HIV血清学检测的"灰区"可以减少血液筛查及归队检测中的假阳性,利于更多的献血者归队;血清学HIV检测反应性献血者的归队标准宜为每次复查间隔时间≥3个月,2次复查合格者即可再次献血。Objective To eliminate the false-positive results of blood donors＇ HIV serological screening and investigate on the reentry conditions of blood donors with false-positive results of serological testing. Methods From January 1st 2013 to June 30 th 2015,follow-up samples from blood dornors with NAT-nonreactive and serological-reactive but not confirmed by western-blot assay were tested using NAT and ELISA followed the rule of routine blood screening but＂Grey region＂of ELISA was canceled. Results Eighty-three HIV positive cases were confirmed and the prevalence rate was 0. 43 ‰（ 83 /192 065）;Four cases were missed by the 3th generation of ELISA（ misdetection rate 2∶ 100 000） while 2 cases by the 4th（ misdetection rate 1∶ 100 000）. The specificity of ELISA with ＂grey region＂was significant lower than that without ＂grey region ＂ for the same HIV ELISA reagents（ In Tec D 95% CI： 0. 06%- 0. 17‰;Bio-Rad D 95% CI： 0. 18- 0. 32‰）. By the end of study,68 donors had been followed with 112 samples tested covering47-867 d per time（ median 194 d） and 89-908 d per person（ median 373 d）. 41 donors retested for only one time and70. 73%（ 29 /41） was negtive; 14 for twice and 57. 14%（ 8 /14） negative; 10 for three times and 90. 00%（ 9 /10） negative;3 for more than three times and 33. 33%（ 1 /3） negative. All confirmatory tests of follow-up samples were negative. Conclusion 4th generation ELISA without＂grey region＂combined with NAT can reduce the rate of false-positive in blood screening and reentry testing,which is useful for increasing reentry efficiency. The standard of reentry of blood donors with HIV serological reactive is suggested that two consecutive follow-up samples are negative for both of tests and the time interval is not less than 3 months.

关 键 词：献血者筛查 HIV 血清学检测 ELISA 假阳性 献血者归队 

分 类 号：R446.6[医药卫生—诊断学] Q503[医药卫生—临床医学]