Establishment of quality control system for domestic hepatitis C diagnostic reagents
2012
Objective
To evaluate the quality of domestic hepatitis C diagnostic reagents objectively,and to build up the quality control systems for assessment of hepatitis C diagnostic reagents.
Methods
4080 serum samples from blood donors were collected and detected with EIA kits.146 anti-HCV positive and negative samples were selected and tested repeatedly by two different imported (Murex and Ortho) and domestic anti-HCV EIA kits(InTec, ZHONGSHAN BIO-TECH,WANTAI and KHB), then confirmed by CHIRON RIBA HCV 3.0 and PCR qualitative reagents.The samples were tested by nucleic acid quantitative assay and the RNA positive samples were detected by genotyping reagents.
Results
The quality control systems of diagnostic reagents of anti-HCV and HCV RNA were constructed.Each quality control system was consisted of 50 samples, including 20 anti-HCV/HCV RNA positive, 20 anti-HCV/HCV RNA negative and 10 diluted specimens for sensitivity evaluation.The positive samples with dominant HCV genotypes in China contained strong, moderate and weak positive samples.The negative samples involved those S/CO value(signal-to-cutoff ratios)close to threshold.
Conclusion
The quality control systems established in this study are suitable for assessment of the new and improved domestic hepatitis C diagnostic reagents.(Chin J Lab Med, 2012,35:137-140)
Key words:
Hepatitis C; Diagnostic reagents; Evaluation; Quality control system
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