Analytical performance of eight rapid point-of-care tests routinely used for the detection of HBsAg in Burkina Faso: A cross-sectional study.

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Armel M SanouDramane Kania

Abstract

In limited resources countries, HBsAg-rapid diagnostic test (RDT) represents a good alternative for the diagnosis of hepatitis B virus (HBV) infection. Due to many factors that can influence their analytical performances, an evaluation with local biological samples before using on a large scale is recommended. The aims of the study were: (i) to evaluate the analytical performance of eight commercial RDTs used in Burkina Faso for the detection of HBsAg using serum from blood donors, and (ii) to propose an algorithm using these RDTs based on their analytical performance. 109 HBsAg-positive and 216 HBsAg-negative samples were included in this evaluation. A modified version of the World Health Organization (WHO) algorithm for the detection of HBsAg was used as the gold standard. A pairwise combination of RDTs performance was done to choose the best diagnostic algorithm. All RDTs presented an excellent specificity (Sp) (≥99.0 %) except Accucare HBsAg® test. Sensitivity (Se) ranged from 90.8 % (95 % CI: 87.9-93.7) for Rapid Signal™ HBsAg to 92.8 % (95 % CI: 90.3-95.5) for SD BioLine® HBsAg and Artron® HBsAg. The pairwise combinations of the Se and Sp of RDTs showed no improvement in diagnostic performance. The RDTs evaluated in this ...Continue Reading

Citations

Mar 13, 2021·Diagnostic Microbiology and Infectious Disease·Stéphane ChevaliezRichard Njouom
Jul 10, 2021·Diagnostic Microbiology and Infectious Disease·Olivier SegeralLaurence Borand
Sep 15, 2021·Applied Biochemistry and Biotechnology·Guolei TanPengfeng Xiao

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