Evaluation of Diagnostic Tests for the Detection of HBsAg in Sample DBS in Children Born to HIV-Positive Mother to HIV-1 in Senegal (Determine AgHBs® vs Microscreen ELISA and HBsAg® Architect HBsAg Qualitative II®)

Abstract

Introduction: According to the World Health Organization, Senegal is the country presenting one of the highest prevalence of HBV (≥ 8%) in the world. However, the diagnosis of this disease remains inaccessible in some areas of the country. We hypothesized that the use of Dried Bloot Spots (DBS) may be potentiated as in the cases of HIV through the use of rapid diagnostic tests to facilitate decentralization of the biology of HBV. Objective: The aim of our study was to evaluate and to compare the sensibility, specificity of three new diagnostic tests with the gold standard test Architect HBsAg Qualitative II® for the diagnosis of HBsAg from DBS samples.. Method: This is a retrospective and comparative study of DBS samples collected from 930 patients between July 2007 and November 2012 in the decentralized sites of Mother-Child HIV Transmission Programme in Senegal. These samples were submitted to hepatitis B antigen detection using three independent tests: the test kit Determine HBsAg®, ELISA Kit Microscreen HBsAg® and ELISA kit Architect HBsAg Qualitative II ®. Results: Patients were predominantly male with 520 (56.0%). Use of HBsAg ® Determine kit showed no reactivity to HBsAg suggesting zero sensitivity. However, we found a sensitivity of 43, 48% [23.22-63.74], a specificity of 99.30% [98.34 to 100.27], a PPV of 83.33% and a VPN of 95.64% for the ELISA Microscreen AgHBs® overlooked ELISA Qualitative Architect II HBsAg ®. Inversely to the sensitivity of the Architect II Qualitative HBsAg® vis-à-vis Microscreen HBsAg ELISA® is 83.33 % [62.25 to 104.42], specificity was 95.64% [93.32 to 97.96] the positive predictive value was 43.48 (PPV), and predictive negative value (NPV) is 99.30%. Conclusion: ELISA Microscreen AgHBs® is the only new test that shows interesting results on the detection of HBsAg. These data and could glimpse its usefulness in the diagnosis of this disease on DBS.