Evaluation of in vitro screening and diagnostic kits for hepatitis C virus infection
| Autor: | Yuji Hoshi, Masamichi Muramatsu, Takanobu Kato, Takaji Wakita, Kuro Toyota, Kazu Okuma, Sahoko Matsuoka, Haruka Momose, Isao Hamaguchi, Emi Ikebe, Asako Murayama, Norie Yamada |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
HBsAg Hepatitis C virus 030106 microbiology Hepacivirus medicine.disease_cause Sensitivity and Specificity 03 medical and health sciences 0302 clinical medicine Virology Genotype Hbv genotype Humans Medicine Low correlation Hepatitis B virus business.industry Viral Core Proteins Reproducibility of Results virus diseases Hepatitis C Antibodies Hepatitis C digestive system diseases In vitro Titer Infectious Diseases Molecular Diagnostic Techniques RNA Viral 030211 gastroenterology & hepatology Reagent Kits Diagnostic Hepatitis C Antigens business |
| Zdroj: | Journal of Clinical Virology. 105:97-102 |
| ISSN: | 1386-6532 |
| DOI: | 10.1016/j.jcv.2018.06.008 |
| Popis: | Background For the diagnosis of hepatitis B virus (HBV) infection, the detection and quantification of hepatitis B surface antigen (HBsAg) and HBV DNA are used. Several kits are available for this purpose, and there is a growing need for the evaluation of these kits because their performance may be affected by HBV genotype- or strain-specific polymorphisms. Objectives and study design In this study, we used International Standards and the established regional reference panel to evaluate the performance of two HBV DNA quantitative kits, five HBsAg qualitative kits, seven HBsAg quantitative kits and three rapid immune-chromatographic tests for HBsAg. Results The quantification values of two HBV DNA quantitative kits exhibited excellent correlation. In the evaluation of HBsAg qualitative and quantitative kits, the titers of several specimens in the HBV-positive panel were below the detection limits of a few kits, and the specimens were determined as HBV-negative. Notably, the quantitative kit results exhibited low correlation values. However, when these data were analyzed for each genotype, the correlations improved. These results suggest that the HBsAg quantification data are influenced by HBV genotypes. The novel rapid immune-chromatographic test exhibited the comparable level of sensitivity to the HBsAg quantitative kits. Conclusions We evaluated the performance of kits for the detection of HBV infection. The HBV DNA quantification data correlated with an excellent agreement, whereas the HBsAg quantification data were affected by HBV genotype. Such evaluations will be useful for estimating the quality of currently available and new HBV assay kits, and for the quality control of these kits. |
| Databáze: | OpenAIRE |
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