Objective: To understand the overall quality of Anti-HCV Colloidal Gold-based Immunoassay Kits in the process of production, circulation and use for the benefit of the quality control and supervision. Methods: Sampling reagents were tested according to the national reference material for rapid detection of anti-HCV Colloidal Gold-based Immunoassays stipulated by the trade standard YY/T 1215—2013. Some products were tested with WHO Seroconversion Panel PHV917(M)HCV Genotype 2b and Seroconversion Panel PHV919 (0610-0217)HCV Genotype 1a to compare the sensitivity differences of different sample kits. Results and Conlusion: Of the 34 batches of samples which were produced according to the industry standards, 33 batches met the requirements of industry standard YY/T 1215-2013 although the positive conversion time was different in the serum detection of WHO HCV series. One batch did not meet the requirements due to the inability to add samples, indicating that the overall quality of domestic Anti-HCV Colloidal Gold-based Immunoassay Kits was good, although the sensitivity of the sample reagents was different. This sampling test has involved 20 approvalnumbers, accounting for 50% of the total approval numbers for such enterprises. It is suggest to extend the sampling scope and develop a series of national HCV Seroconversion Panels.
Yu Yang, Li Ying, Zhang Jin, Gu Jinlian, Duan Xinxin, Zhou Cheng
. Analysis and Suggestions on Sampling Test of Anti-HCV Colloidal Gold-based Immunoassays Kits[J]. Chinese Pharmaceutical Affairs, 2021
, 35(3)
: 274
-280
.
DOI: 10.16153/j.1002-7777.2021.03.006
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