Problems and solutions on standardization of reagents for detection of HBV and HCV infection
10.3760/cma.j.issn.1009-9158.2010.10.001
- VernacularTitle:乙型和丙型肝炎病毒感染检测试剂的标准化:问题与对策
- Author:
Jinming LI
- Publication Type:Journal Article
- Keywords:
Hepatitis B virus;
Hepacivirus;
Polymerase chain reaction;
Indicators and reagents;
Reference standards
- From:
Chinese Journal of Laboratory Medicine
2010;33(10):901-904
- CountryChina
- Language:Chinese
-
Abstract:
Compared with commercial reagents manufactured by foreign companies for detection of HBV and HCV infection, domestic reagents have poorer performance because of the over-pursuit of easy operation and lack of metrological traceability in quantitative measurement. If "two-step" sandwich ELISA model and multiple monoclonal coating antibodies were used, false-negative results caused by the hook-effect and HBsAg mutant would be avoided. Moreover, sufficient incubation time in each step would improve the detection-limit of the reagents. By replacing the boiling lysis with nucleic acid purification in sample preparation and increasing the sample volume of nucleic acid purification and amplification detection could improve the detection-limit and reproducibility of HBV and HCV nucleic acid testing. The use of internal control could effectively monitor the of false negative results as well Application of international or national reference materials for metrological traceability of calibrators in reagents also plays an important role in assuring result concordance among different commercial reagent kits, methods and clinical laboratories.
