献血者HIV 1/2血清学ELISA检测初试灰区标本的结果分析

Analysis of the results of the initial grey zone donors by HIV1/2 ELISA

目的分析杭州地区ELISA方法检测HIV 1/2初试呈现"灰区"的献血者检测结果,探讨初试"灰区"献血者的安全性及"灰区"设置的合理性。方法回顾性分析2014年1月-2016年6月HIV1/2 ELISA初试"灰区"献血者的血液筛查及复试反应性标本的抗体确证结果,计算复试反应性"灰区"献血者的HIV阳性预测值(PPV)。结果在检测的404 430例献血者血液标本中,286例(0.07%)为初试HIV1/2 ELISA"灰区"标本(HIV RNA均为非反应性)。国产和进口HIV1/2 ELISA试剂检出的初试"灰区"标本比例接近(0.04%vs 0.03%,P>0.05)。53例(0.01%)HIV1/2抗原/抗体反应性"灰区"标本的抗体确证结果均为阴性,"灰区"献血者HIV阳性预测值为0。结论核酸检测开展后,HIV1/2 ELISA"灰区"设置提升血液安全作用有限,反而增加日常工作量和献血者的误淘汰。

Objective To analyze the results of the initial grey zone donors by HIV1/2 the enzyme-linked immunosorbent assay（ ELISA） and to evaluate whether these donors are viable blood source based on the data acquired. Meanwhile,the necessity of grey zone establishment is briefly investigated. Methods A retrospective analysis was performed on blood screening results of the initial grey zone samples collected during January 1 st,2014 to June 30 th,2016 with confirmatory tests of HIV antibodies. Thus,the positive predictive value（ PPV） of HIV for the grey zone donors could be calculated. Results The data demonstrate that 286 HIV-RNA non-reactive samples fell into the initial grey zone out of the 404430 total sample pool at 0. 07%. The detection ratio of the domestic reagent adopted regarding the initial grey zone samples was identical compared to the imported one at 0. 04% vs 0. 03 %,P〈0. 05. Within the 286 samples,53 reactive samples proved to be negative for confirmatory anti-HIV tests,yielding a PPV of zero for HIV-positivity. Conclusion With the nucleic acid amplification test involved,establishing grey zones in HIV1/2 ELISA tests presents very limited effect to enhance blood safety.We would argue doing so would merely increase the daily workload and the number of false sample rejections.