Performance of rapid diagnostic tests for the detection of anti-HBs in various patient populations.

BACKGROUND: Rapid diagnostic tests (RDTs) represent an attractive alternative method to conventional diagnosis of hepatitis B virus (HBV) infection.

OBJECTIVE: The aim of the present study was to evaluate the diagnostic performance of commercially available RDTs for the detection of anti-HBs in various patient populations.

STUDY DESIGN: A total of 347 individuals, 198 positive and 149 negative for anti-HBs, were studied.

RESULTS: The specificity of RDT detection of anti-HBs in serum was 98.0%, 96.0% and 97.3% with TOYO® HBsAb Test, QuickProfile™ HBsAb test and QuickProfile™ HBV-3 Panel test, respectively. The diagnostic sensitivity varied between 60.4% and 69.5%. The sensitivity of the three RDTs was markedly better when testing serum samples with an anti-HBs titer higher than 100IU/L, and reached 90% or more for an anti-HBs titer above 150IU/L.

CONCLUSIONS: This performance was disappointing because the assays were not sensitive enough to detect low antibody titers. Thus, these tests require further improvement before they can be widely used in clinical practice.