Multicenter Evaluation of a Semiautomated, Standardized Assay for Detection of Hepatitis B Virus DNA in Blood Donations

Abstract

We evaluated the COBAS Ampliscreen hepatitis B virus (HBV) test using standards, seroconversion panels, consecutive donations, and samples from patients with abnormal alanine aminotransferase and chronic hepatitis C. Specificity was 100% and sensitivity was 20 IU/ml. In seroconversion panels, HBV DNA was detected up to 4 to 18 days before HBsAg, suggesting that this assay is useful in shortening the infectious window phase.

Acute hepatitis B virus window‐period blood donations detected by individual‐donation nucleic acid testing: a report on the first two cases found and interdicted in Spain

“…The acute hepatitis B virus (HBV) infection window period extends from 37 to 87 days (mean, 59 days) 1 after acquisition of the virus. Both HBV surface antigen (HBsAg) and total antibody to HBV core antigen (anti‐HBc) test negative during this period; however, the HBV genome can be detected in plasma by molecular tests as shown by seroconversion panel testing 2 . Blood units donated during the early acute infection period are not identified by current mandatory testing; nevertheless, blood products obtained from these units might transmit HBV to transfusion recipients.…”

A novel hepatitis B virus surface antigen immunoassay as sensitive as hepatitis B virus nucleic acid testing in detecting early infection

“…It is considered to be a superior technique for the early detection of HBV infection 24,25,28 . However, despite the regular use of minipool NAT for blood donor screening, the risk of posttransfusion HBV infection persists 20‐25 . In this study, we developed an unprecedented high‐sensitivity HBsAg detection prototype and investigated whether such an assay could reduce the risk of undesired HBV transmission.…”

“…Despite the fact that many countries perform HBV DNA and HBsAg screening tests, posttransfusion HBV infection continues to occur 20‐25 . This is because a relatively long infectious window period remains before HBV DNA and HBsAg become detectable in serum 19‐22,24‐30 1,26 .…”

“…Although the sensitivity of the HBsAg assay has been improved, reduction in the window period such that it is similar to that of DNA detection remains difficult 18,19,24,25,27‐29,31 . The window period for HBV detection has been estimated to be 35 to 76 days by individual sample nucleic acid testing (NAT), 41 to 90 days by minipool NAT, and 50 to 97 days by high‐sensitivity HBsAg chemiluminescent immunoassay (CLIA) 28,30 .…”

PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation

“…173 NAT assay were reactive 10-20 days before HBsAg. 169,174 No studies reported turnaround time for conducting the test.…”