|Title:||Performance of commercially available anti-HDV enzyme-linked immunosorbent assays in Taiwan||Authors:||Lin G.-Y.
|Keywords:||ELISA; HDV; Kit evaluation; Sensitivity; Specificity||Issue Date:||2020||Publisher:||BioMed Central Ltd.||Journal Volume:||17||Journal Issue:||1||Start page/Pages:||76||Source:||Virology Journal||Abstract:||
Background: Hepatitis D virus (HDV) infection is a major global health issue around the world. There are approximately 15-20 million individuals infected with HDV worldwide. HDV infection usually causes increased mortality compared with infection with hepatitis B virus (HBV) alone. However, testing for the detection of HDV is not widely available in Taiwan. Therefore, the General Biologicals Corporation (GB) HDV Ab kit was developed for detecting anti-HDV antibodies. Methods: A total of 913 serum and 462 EDTA-treated plasma samples were obtained from HBsAg-positive individuals in three hospitals in Taiwan from June 2014 to November 2017. We used three commercially available ELISA kits, DiaPro HDV Ab, DiaSorin ETI-AB-DELTAK-2 and GB HDV Ab, which were utilized strictly according to the instructions of the manufacturers. Results: A comparative study of the results from the GB HDV Ab kit and the other commercial ELISA kits (DiaPro and DiaSorin) was performed to determine their efficacy for anti-HDV detection. The results indicated that the sensitivity of the GB HDV Ab kit for serum and EDTA samples was 100% compared to that of the DiaPro and DiaSorin kits, whereas the specificity for serum and EDTA samples was 99.3 and 98.1%, respectively. In addition, the overall agreement of the results of the GB HDV Ab kit for the serum and EDTA samples was 99.3 and 98.3%, respectively. It is worth noting that the performance of the GB HDV Ab kit was not affected by interference from triglyceride, bilirubin, hemoglobin, or human anti-mouse antibody. The limit of detection of the GB HDV Ab kit is approximately 100-fold lower than that of the other two commercial kits. Conclusions: The GB HDV Ab kit, which presented equivalent sensitivity and specificity compared to both certified anti-HDV kits, would be a suitable kit for HDV diagnosis in Taiwan. ? 2020 The Author(s).
|ISSN:||1743-422X||DOI:||10.1186/s12985-020-01355-5||SDG/Keyword:||bilirubin; hemoglobin; hepatitis B surface antigen; triacylglycerol; virus antibody; hepatitis antibody; antibody detection; Article; comparative effectiveness; controlled study; enzyme linked immunosorbent assay; Hepatitis delta virus; human; limit of detection; major clinical study; sensitivity and specificity; serum; Taiwan; blood; comparative study; delta agent hepatitis; diagnostic kit; enzyme linked immunosorbent assay; Hepatitis delta virus; immunology; Enzyme-Linked Immunosorbent Assay; Hepatitis Antibodies; Hepatitis D; Hepatitis Delta Virus; Humans; Limit of Detection; Reagent Kits, Diagnostic; Sensitivity and Specificity; Taiwan
|Appears in Collections:||臨床醫學研究所|
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