RESUMEN
【Objective】 To detect and analyze the infection status of HBsAg non-reactive /HBV DNA reactive blood donors by individual donor-NAT (ID-NAT) and chemiluminescence technology, and to explore the feasibility and potential risks of reentry. 【Methods】 The blood screening results of blood donors in Wuhu from January 2018 to October 2021 were queried by blood station information management software. The blood donation information of all HBsAg non-reactive /HBV DNA reactive blood donors was collected and then recalled by telephone. After informed consent, samples were taken for HBV DNA nucleic acid single test, enzyme-linked immunoassay for HBsAg, chemiluminescence assay for HBV seromarkers(including HBsAg, anti-HBs, HBeAg, anti-HBe and anti-HBc), and alanine aminotransferase (ALT) test. All the results were statistically analyzed. 【Results】 From January 2018 to October 2021, there were 142 051 donations, and the positive rate of sole HBV DNA was 0.06% (91/142 051), and 33 people (37 person-times) were successfully followed up. The yield rates of HBsAg, anti-HBs and anti-HBc were 6.06% (2/33), 39.39% (13/33) and 96.97% (32/33), respectively; None HBeAg was yielded. After two times of ID-NAT, 8 patients remained non-reactive to both systems, with a negative conversion rate of 24.24% (8/33). Meanwhile, 25 patients were at least once reactive to ID-NAT, and 23 of them were occult HBV infection with serologically reactivity. There were 2(6.25%) patients with HBsAg positive conversion and HBV DNA persistent reactivity, which were window period infection. One person was confirmed as false reactivity (no HBV infection) as he remained unreactive to both repeated ID-NAT and serological tests. 【Conclusion】 Chemiluminescence assay is more sensitive than ELISA in detecting HBV serum markers, which is beneficial to early detection of HBV samples in window period. The yielding rate of anti-HBc among HBsAg non-reactive/HBV DNA reactive blood donors detected by blood screening in this region is very high, and most of them are occulting infection, so the ID-NAT should be no less than 2 times in the reentry strategy.
RESUMEN
Objective To analyze hepatitis B virus(HBV) infection stage in single nucleic acid test(NAT)reactive blood donors.Methods Blood donor samples were screened routinely for HBV DNA by using transcription-mediated amplification(TMA) NAT and quantitative polymerase chain reaction(PCR).Then serum markers of HBV were also detected.The HBV infection stage was analyzed.Results Among the 225 single NAT reactive samples,78(34.67%) were identified to be reactive for HBV DNA by TMA NAT discrimination test and/or PCR test,of which 63(82.89%) were occult HBV infection(OBI),13(17.11%) were probably window period infection(pWP),and 2 cases could not be classified for infection stage.Among the OBI samples,49 samples(77.78%) were with HBV DNA concentration less than 20 IU/mL,whereas,there were only 4 samples(30.77%) in pWP samples.The 225 samples were classified into three groups according to the S/CO of NAT, including 1-<6 group,6-<10 group and 10-17 group, the confirmed HBV DNA positive rates of which were 13.11%,13.64% and 47.18%,and the positive rate of 10-17 group was higher than 1-<6 group and 6-<10 group(P<0.05).In all 63 OBI samples,there were 8(12.70%),3(4.76%) and 52(82.54%) samples were classified into S/CO 1-<6,6-<10 and 10-17,respectively.All of the 13 pWP samples were with NAT S/CO of 10-17.Conclusion Part of single NAT reactive blood donors could be with HBV infection,of which OBI might be popular than pWP, with very low concentration of HBV DNA.Deferral of single NAT reactive blood donors could reduce transfusion-transmitted HBV infection.