Title : COMPARATIVE EVALUATION OF TWO RAPID DIAGNOSTIC TEST DEVICES AND REAL-TIME PCR FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGENS IN HUMAN PLASMA: IMPLICATIONS IN BLOOD DONATION SCREENING


Authors : Kazi Nadim Hasan, Tanzila Wasi, Nahian Anjum Shejuti, Aniqa Afzal, Sohidul Islam.

Abstract : Background and Aims: Hepatitis B Virus (HBV), a parenterally transmitted infectious virus, is one of the leading causes of hepatitis. Screening for HBV infection is recommended before vaccination and blood transfusion in order to prevent its transmission. Immunochromatography (ICT) based rapid HBsAg kits are popular for the screening of HBV infection as they are faster, cheaper and easier to perform than other methods. This study was aimed to evaluate two rapid HBsAg detection ICT kits for the screening of HBV infection by comparing them with the gold standard real-time polymerase chain reaction (real-time PCR) system that quantifies HBV-DNA. Materials and Methods: The study comprised 203 samples, of which 103 had detectable and 100 had no detectable HBV-DNA by real-time PCR. These samples were tested with ICT kits from two companies: OnSite HBsAg Rapid Test (CTK Biotech, Inc., USA) and HBsAg Test Device (EXCEL®, USA). Results: Sensitivity of CTK and EXCEL were found to be 97.1% and 95.1% respectively. Negative predictive value (NPV) of CTK and EXCEL were 97.1% and 95.2% respectively. Both kits showed 100% specificity and 100% positive predictive value (PPV). HBV-DNA status strongly correlated with CTK (r = 0.971, p < 0.001) and with EXCEL (r = 0.952, p < 0.001). Three and five moderate to high HBV load containing samples were undetected by CTK and EXCEL respectively. Conclusions: The study demonstrates that ICT based Rapid Test Devices might be considered suitable for screening of HBV infection as a point of care test. However, Nucleic Acid Testing for hepatitis B virus (NAT-HBV) should be implemented for donor screening for HBsAg.


Journal : Volume : Year : 2017 Issue :
Pages : 17 - 25 City : Bankok Edition : 6 Editors : Srisin Khusmith, Paul Adams, Pornpimon Adams, Pitchapa Vutikes , Wijak, Anowannaphan, Ailada Angatchariya
Publisher : JITMM Secretariat, Faculty of Tropical Medicine, Mahidol University, Thailand ISBN : Book : Chapter :
Proceeding Title : PROCEEDINGS OF THE JOINT INTERNATIONAL TROPICAL MEDICINE MEETING (JITMM) 2016 Institution : Issuer : Number :