Rapid point-of-care first-line screening tests for hepatitis B infection: a meta-analysis of diagnostic accuracy (1980-2010).
OBJECTIVE
Three-hundred fifty million people worldwide are chronically infected with Hepatitis B, with four million acute infections annually. With infection concentrated in hard-to-reach populations and low resource settings, rapid point-of-care (POC) tests offer an efficient screening alternative to laboratory tests. We conducted a meta-analysis to evaluate accuracy of rapid POC tests screening for Hepatitis B.


METHODS
Two reviewers searched four databases, critiqued quality. A hierarchical Bayesian meta-analysis correcting for imperfect reference standards was used. Based on components of the antigen-antibody response, 17 studies were stratified into three subgroups: (i) Hepatitis B surface antigen (HBsAg) tests; (ii) anti-HBsAg tests, and (iii) HBs+eAg tests. Further, we pooled estimates on individual tests with sufficient data.


RESULTS
In subgroup 1, the pooled sensitivity (Sn) was 94.76% (95% credible interval (CrI): 90.08-98.23%) and specificity (Sp) was 99.54% (95% CrI: 99.03-99.95%). The Determine test reported a pooled Sn 98.2% (95% CrI: 94.7, 99.9) and Sp 99.9% (95% CrI: 99.3, 100); in subgroup 2, Sn 93.2% (95% CrI: 85.1, 98.5), Sp 93.1% (95% CrI: 81.9, 99.9); and in subgroup 3, the Binax test showed Sn 95.5% (95% CrI: 88.9, 99.4), Sp 99.8% (95% CrI: 99.3, 100).


CONCLUSIONS
HBsAg tests, including Determine, and the HBs+eAg test, Binax showed high accuracy. Improvements in sensitivity of antibody-based tests will enhance their potential for global first-line screening.
Division of Clinical Epidemiology, McGill University and Health Center, Montreal, Quebec, Canada.
Sushmita
S
Shivkumar
Rosanna
R
Peeling
Yalda
Y
Jafari
Lawrence
L
Joseph
Nitika Pant
NP
Pai
D001499:Bayes Theorem; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000032:analysis*; D006801:Humans; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity
D006514:Hepatitis B Surface Antigens