无偿献血者HBsAg检测反应性标本的确证分析OA

Objective To systematically analyze the confirmatory positivity of different combinations of HBsAg screen-ing results in blood testing,providing data to support the optimization of blood donor eligibility management.Methods A retrospective analysis was conducted on blood screening data from 174 266 voluntary blood donor samples at the Chongqing Blood Center between October 2021 and September 2022.Samples with inconsistent results between the two HBsAg enzyme-linked immunosorbent assays(ELISA)and individual donor nucleic acid testing(NAT)were confirmed using an electro-chemiluminescence immunoassay(ECLIA)and a neutralization test.The detection efficacy of four different HBsAg ELISA reagents was compared using the HBsAg-confirmed positive samples.Results A total of 767(0.44%)HBV-reactive(HB-sAg and/or HBV DNA reactive)samples were detected.Among them,344 samples with discordant serological and NAT re-sults were collected,of which 64(18.6%)were confirmed positive by neutralization test.Additionally,5 samples that were neutralization-negative but double-reactive for HBsAg and HBV DNA were confirmed as positive according to FDA guidance,resulting in a total of 69(20.1%)confirmed HBsAg-positive samples.There were significant differences in the neutraliza-tion test confirmation rates among different screening result categories(P＜0.05):The group with dual HBsAg reagent reac-tivity(double reactive)&NAT-negative had the highest confirmation rate(96.9%,31/32);the group reactive to only rea-gent 2(single reactive)had a rate of 25.7%(29/113);while the confirmation rates for samples reactive to only reagent 1 and samples with isolated HBV DNA positivity were extremely low[0(0/34)and 2.4%(4/165),respectively].The four commercial reagents showed significant differences in their ability to detect confirmed positive samples that were initially sin-gle reactive(P＜0.05).Conclusion Given the performance variations among HBsAg screening reagents,thorough per-formance verification is essential before implementation.When NAT is negative,dual HBsAg reactivity in screening can serve as a basis for confirming infection and directly deferring blood donors.However,confirming infection in donors with single HBsAg reactivity is more challenging,necessitating supplementary tests to rule out infection risk.