Background: The false reactivity results of nucleic acid screening reagents have been reported in China and abroad. To identify false reactivity, effectively protect the rights of blood donors, and cherish limited blood resources, many countries study the methods of re-entry of NAT reactive blood donors.
Methods: ELISA non-reactive and NAT-reactive donors who donated blood in 2012 - 2017 were selected, and informed consent was obtained. The collected blood samples were tested by ELISA and NAT. Then, the samples were tested by ECLA for HBsAg, HBeAg, anti-HBs, anti-HBc, anti-HBe, anti-HCV, and anti-HIV.
Results: Forty-two donors were called back and tested: 15 of them were ELISA non-reactive/NAT-reactive, and 27 of them were ELISA non-reactive/NAT non-reactive. The ECLA results indicated that 90.5% ELISA non-reactive/NAT non-reactive donors were anti-HBc-reactive and/or anti-HBe-reactive (21 cases anti-HBc/anti-HBe-reactive, 17 cases anti-HBe-reactive). After 6 mouths, anti-HBc-reactive or anti-HBe-reactive donors were also anti-HBc-reactive and/or anti-HBe-reactive, and these donors were deferred permanently. Four cases that were non-reactive to all tested results may be eligible for re-entry.
Conclusions: In view of blood safety, it is important to establish a set of safety criteria to allow re-entry of ELISA non-reactive/NAT-reactive blood donors.