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Follow‐up program for blood donors with unconfirmed screening results reveals a high false‐positive rate in Dalian, China
Author(s) -
Deng Xuelian,
Zang Liang,
Wang Xinmei,
Chen Hui,
Liu Jiangdi,
Gao Yong,
Xu Shuang,
Wang Li,
Fan Yaxin,
Candotti Daniel,
Liang Xiaohua
Publication year - 2020
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.15656
Subject(s) - serology , medicine , nat , hbsag , virology , immunology , human immunodeficiency virus (hiv) , hepatitis b virus , antibody , virus , computer network , computer science
ABSTRACT BACKGROUND Chinese blood donors with unconfirmed serological and/or molecular screening results are deferred permanently. This study investigated the implementation and performance of a follow‐up program aiming to improve the notification and management of deferred donors in Dalian, China. STUDY DESIGN AND METHODS From January 2013 to February 2018, 411,216 donations were tested for HBsAg, anti‐HCV, anti‐HIV/HIV antigen, and antibodies to Treponema pallidum. HBV, HCV, and HIV nucleic acid testing (NAT) was performed in mini‐pools of six or in individual donations (IDs). Reactive donations were evaluated further with alternative serological assays and ID‐NAT re‐testing. A follow‐up procedure was developed to evaluate a subset of deferred donors that were either potential NAT yield cases, serology non‐reactive and NAT non‐repeated reactive (NRR), or serology NRR irrespective of NAT result. RESULTS Serological and molecular routine, plus supplemental testing, identified HBV, HCV, HIV, and TP in 503 (0.12%), 392 (0.09%), 156 (0.04%), and 2041 (0.49%) donations, respectively. Overall, 683 of 4156 (16.4%) eligible donors and 205 donors deferred prior 2013 participated in the program. They included 664 serology NRR and 224 NAT yield cases, and 58.8% repeat donors. All markers combined, follow‐up documented false reactivity, primary acute infections, and OBI in 61.9% (550/888), 3.3% (29/888), and 12.8% (114/888) of these donors, respectively. Isolated anti‐HBc or anti‐HBs reactivity was observed in 22% of cases. CONCLUSION Follow‐up testing refined infection status in 78.0% (693/888) of deferred donors with unconfirmed screening results. This high false‐positive rate encouraged to reevaluate the current screening strategies and to consider donor reentry.