Systematic review of the validity of the hepatitis B virus detection tests in blood banks from 2000 to 2018

Background Hepatitis B Virus (HBV) is a public health problem that causes chronic hepatitis, eventually evolving to cirrhosis and hepatocellular carcinoma. Given the low frequency of screening in the general population, blood banks represent a key element for monitoring and controlling HBV transmission. The objective of this work was to evaluate the validity of the diagnosis of HBV in blood banks, based on studies published in the world scientific literature from 2000 to 2018. Methods We used a Meta-analysis of random effects with application of a search and selection protocol according to Cochrane and PRISMA guidelines. Reproducibility, completeness and quality assessment were affirmed with QUADAS, a tool for assessing diagnostics. The parameters of sensitivity, specificity, likelihood ratios, odds ratio and ROC curve were analyzed in MetaDisc with 95% confidence. Results From 4,061 studies screened, only 12 complied with the protocol, and the compliant studies included a population of 17,391 healthy people and 1,229 infected. The compliant studies evaluated mainly immunodiagnostics (ELISA) using HB surface antigen (HBsAg) and less frequently anti-HBc (HB core antigen) and PCR. The tests for HBsAg presented sensitivity of 94.1% (95% CI = 92.9% - 95.1%), specificity 98.2% (95% CI = 97.8% - 98.6%), diagnostic OR of 1721 (95% CI = 607.18 - 4418.8) and Area Under the Curve of 99.7%. Conclusion With a large sample size and with the high quality of the studies evaluated in this review, we confirm that HBsAg for HBV immunodiagnostics has excellent validity, which supports its use in clinical screening, blood banks and population surveillance programs.