YY/T 1581-2018: Translated English of Chinese Standard. (YYT 1581-2018, YY/T1581-2018, YYT1581-2018): Allergy-specific IgE detection kit
https://www.chinesestandard.net, 20.1.2019 - 18 sivua
This Standard specifies the requirements, test methods, label and instructions for use, packaging, transportation, and storage of allergy-specific IgE detection kit. This Standard is applicable to the kit in the medical laboratory for quantitative/semi-
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Label and instructions for use
According to formula allergy detection items allergy items batch numbers Calculate the mean coefficient of variation coincidence rate Detect concentration levels containing total IgE CV is obtained Detect according Detect negative national Detect negative reference detection result different levels enterprise’s reference materials equal to 15 Expiration date stability GB/T IgG sample Inter-batch difference kits least 2 different least 2 levels less than 700 levels of positive linear interval linear regression manufacturing enterprise material coincidence rate material under detection mean value meet the requirements mixed/combined/multivalent allergy detection national reference materials negative national reference Negative reference material numbers to detect positive and weakly positive reference materials reference material coincidence reference materials provided relative deviation repeated detection repetitive reference materials requirements of 3.1.3 result shall meet sample B solution sample containing total sample of 7000 samples for repeated SELECT the product serum or plasma standard deviation SD variation CV weakly positive reference weakly positive samples