Abstract
A 2014 report evaluating accuracy of serologic testing for transfusion-transmissible viruses at African blood center laboratories found sensitivities of 92%, 87%, and 90% for detecting infections with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), respectively (1). Following substantial investments in national blood transfusion service (NBTS) laboratories, in 2017 investigators tested proficiency at 84 blood center laboratories (29 NBTS and 55 non-NBTS) in seven African countries. A blinded panel of 25 plasma samples was shipped to each participating laboratory for testing with their usual protocols based on rapid diagnostic tests (RDTs) (2) and third and fourth generation enzyme immunoassays (EIA-3 and EIA-4). Sensitivity and specificity were estimated using separate regression models that clustered assays by laboratory and adjusted for assay type and NBTS laboratory status. Mean specificities were ≥95% for all three viruses; however, mean sensitivities were 97% for HIV-positive, 76% for HBV-positive, and 80% for HCV-positive samples. Testing sensitivities for all viruses were high when EIA-3 assays were used (≥97%). Lower sensitivities for HBV-positive samples and HCV-positive samples were associated with assay types other than EIA-3, used primarily by non-NBTS laboratories. Proficiency for HIV testing has improved following international investments, but proficiency remains suboptimal for HBV and HCV testing. In sub-Saharan African blood centers, the quality of rapid tests used for HBV and HCV screening needs to be improved or their use discouraged in favor of EIA-3 tests.
Highlights
This study found higher sensitivity for detecting HIVpositivity but lower sensitivity for detecting hepatitis B virus (HBV)- and HCVpositivity than is generally associated with the use of RDTs, compared with previous studies using similar methods (1,2)
These results suggest that RDT assays targeting human immunodeficiency virus (HIV) perform better or have better quality assurance than do RDT assays targeting the hepatitis viruses
The poorer performance of RDT assays for detecting HBV- and hepatitis C virus (HCV)-positivity is most likely attributable to the quality of the assays themselves, because deficiency in performing the tests could have been signaled by lower mean accuracy at non-national blood transfusion services (NBTS) compared with NBTS laboratories
Summary
Substantial international investments have been made in African national blood transfusion services (NBTS) following reports of deficiencies in viral marker screening at African blood center laboratories. Standardized proficiency testing conducted in seven African countries during 2017 found that proficiency in human immunodeficiency virus testing has improved, but testing proficiency for hepatitis B virus (HBV) and hepatitis C virus (HCV) needs to be improved. Most poor performance in hepatitis virus testing can be attributed to the use of rapid tests rather than the non-NBTS setting of the laboratories. Remediation should be focused on improving the quality of rapid tests or avoiding their use
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
