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Rapid tests effectively detected HBsAg

Three rapid tests conducted at various Paris-based health care centers effectively screened patients and detected hepatitis B surface antigen, according to recent study results.

Researchers evaluated three rapid test devices to screen 3,956 participants for hepatitis B surface antigen (HBsAg) and used one of the methods to detect anti-hepatitis B surface antibody (anti-HBsAb). They also compared the devices’ results with the gold standard, enzyme-linked immunosorbent assay (ELISA) serology.

Tests were administered using the Vikia (Biomerieux), Determine (Inverness Biomedical Innovations) and Quick Profile (Lumiquick) systems to determine HBsAg sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively) and area under the ROC curves. The Quick Profile system also tested for anti-HBsAb.

Participants had 10 mL whole blood drawn, from which samples were used in each testing device and evaluated by ELISA. Eighty-five participants were determined as HBsAg positive and 2,225 displayed an anti-HBsAb titer. All three testing devices had specificity for HBsAg greater than 99.0%, sensitivity ranged from 90.5% (Quick Profile) to 96.5% (Vikia), and each gained minimal noninferiority criteria. Inactive HBsAg participants generally displayed false positives.

Researchers considered anti-HBsAb specificity and PPV excellent (97.8% and 97.1%, respectively), while sensitivity (58.3%) was low and failed to establish noninferiority to ELISA.

“Given the ease of use, rapidity and high classification probabilities, the HBsAg tests evaluated in this study should be considered ideal for HBV screening, particularly among institutions in which patients are frequently lost to follow-up or where testing via ELISA is not readily available,” the researchers concluded. “More data on the medical-economic impact of including rapid tests are needed, especially in low-prevalent countries with abundant financial resources but limited systematic screening.”