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- W266609158 abstract "Objective To analyze the intra-and inter-reliability as well as its influence to the reagent quality of domestic anti-HCV ELISA kits by analyzing the test results of national reference materials detected by different kits of several manufacturers.Methods The second batch of the third generation national reference materials(including 40 positive sera and 40 negative sera)were used as controls to detect the intra-and inter-reliability of the tested kits.The inter-CV value,standard deviation and standard error were calculated according to the absorbance values of the sera ingray zonedetected by the same reagent of different batches.Results The different domestic reagents had different missing detections of the antibodies to Core or NS3 regions.The CV values of weakly positive serum samples detected by reagents of different batches from the same manufacturer were relatively high.The test results of serum samples ingray zonechanged greatly.Conclusion It is recommended that the reagent manufacturers should establish a threshold for the control serum to control the test results of specimens in thegray zone,and to ensure the inter-reliability of the reagents." @default.
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- W266609158 date "2009-01-01" @default.
- W266609158 modified "2023-09-28" @default.
- W266609158 title "An analysis of intra-and inter-reliability of domestic anti-HCV kits" @default.
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