Re-Entry Evaluation of Chinese Blood Donors with Unconfirmed Hepatitis B Screening Results

Abstract

The hepatitis B virus (HBV) remains a high priority for Chinese blood banks due to the high prevalence of infection. HBV blood safety has been significantly improved by the implementation of highly sensitive and specific serological and molecular HBV screening assays. The multiplication of viral markers tested and the ever-increasing analytical sensitivity of the tests can make the interpretation of the results difficult. False-positive or indeterminate results may lead to permanent donor deferrals and conflicts between donors and blood banks. To avoid blood shortages, blood services aim to limit unnecessary donor losses by developing procedures for the re-entry of donors temporarily deferred due to an unconfirmed HBV reactivity. The development of such procedures based on donor follow-up and HBV confirmation remains limited. A review of the scarce data available revealed considerable heterogeneity in testing methods and re-entry algorithms, limited validation studies, and a lack of accurate assessment of the residual infectious risk potentially associated with donor re-entry. In conclusion, systematic and widely validated confirmatory testing and prolonged follow-up are essential for safe re-entry of temporary deferred donors. Standardization of HBV testing methods and the establishment of dedicated expert laboratories are needed because of the complexity of HBV infection in blood donors.

Establishing a screening strategy for non-discriminatory reactive blood donors by constructing a predictive model of hepatitis B virus infection status from a single blood center in China

“…Therefore, the final interpretation of positive screening results can be highly challenging for TMA screening methods, where initially reactive donations in multiplex testing may yield in non-reactive results in discriminatory analysis. Studies have reported that these donors expected to have a Poisson distribution of HBV-DNA levels near the limit of detection (LOD) in the blood, particularly in OBI donors characterized by extremely low HBV-DNA levels in the plasma ( 2 ). Our research also found that these donors experience fluctuations in viral load, significantly affecting the detection results ( 8 ).…”

“…Furthermore, anti-HBc screening cannot identify WP infection and has low specificity, with false positive rates ranging from 16 to 75% ( 22 ). In addition, studies have also found a certain proportion of OBI blood donors who are anti-HBs positive but anti-HBc non-reactive ( 2 , 16 , 23 , 24 ). In this study, we also identified 6 cases of OBI blood donors who were anti-HBs single reactive.…”

“…In our study, 45.80% (120/262) of non-repeat reactive blood donors demonstrated a certain degree of HBV infection, and all tested negative in repeat testing. Additional experiments, including viral load detection, HBV serological markers, and follow-up experiments ( 2 , 16 , 17 , 27–29 ), were conducted to determine the infection status of the blood donors. However, research has proven that the confirmation rate of follow-up is considerably lower than that of confirmation/supplementary experiments, due to the compliance of blood donors with follow-up and the fluctuation of blood-borne viruses ( 2 ).…”

“…Therefore, blood screening for HBV is essential in reducing the transmission of infectious diseases by transfusion and is a high priority for blood banks. In addition to the screening strategy based on hepatitis B virus surface antigen (HBsAg) detection, since 2010, nucleic acid testing (NAT) technology has been implemented to simultaneously detect HBV-DNA, HCV-RNA, and HIV-RNA in a few pilot blood banks nationwide, including the Blood Center of Zhejiang Province starting from August 1, 2010 ( 2 ).…”

Viruses Special Issue “Transfusion-Transmitted Viral Infections”

“…However, screening assays with a high analytical sensitivity may lead to an increased risk of false positive results, leading to donated blood being discarded and permanent donor deferral. Therefore, the further development of complex testing algorithms seems to be essential in order to confirm initially reactive results and, thus, preserve and maintain a stable blood supply, as explained by Deng and colleagues [ 10 ] in China, a highly endemic region for HBV.…”