Hepatitis B virus infection confirmation and infection status identification in blood donors without serological markers / 中国输血杂志

ABSTRACT

【Objective】 To confirm Hepatitis B virus (HBV) infections and identify infection status by excluding false positive in blood donors reactive to nucleic acid testing (NAT) but without serological markers (Seroneg-NAT). 【Methods】 Seroneg-NAT yields were selected among blood donors in Dalian Blood Center from November 1, 2010 to February 28, 2021, and their HBV DNA was further confirmed with TaqMan HBV DNA quantification or virions concentration by polyethylene glycol (PEG) precipitation combined with in-house nested PCR targeting the S, BCP, PreS/S and Precore/core regions of the viral genome, and follow-up test was carried out, including blood routine screening and HBsAg, anti-HBs and anti-HBc testing. HBV infection was confirmed by HBV DNA yielding and anti-HBs/anti-HBc seroconversion in follow-up testing, and HBV DNA was further sequenced if necessary. 【Results】 During the period of 10 years and 4 months, 0.03% (126/466 911) Seroneg-NAT yields were selected, of which 46.8% (59/126) were HBV DNA+ and 53.2% (67/126) were unconfirmed. Among 126 Seroneg-NAT yields, 40.5% (51/126) were involved in follow-up test, of which 28 were HBV DNA+ and 23 were unconfirmed. HBV infections were confirmed in 48% (60/126) of Seroneg-NAT yields. Of follow-up donors, 54.9% (28/51) were identified as early infection before seroconversion, 2.0% (1/51) seronegative occult HBV infection (OBI), and 37.3% (19/51) NAT false positive. There were still 5.9% (3/51) classified as the indetermination. 【Conclusion】 Nearly half Seroneg-NAT yields in Dalian blood donors were infected with HBV and more than 50% were early infections before seroconversion. The majority of HBV DNA unconfirmed without serological markers were false positives.