YY/T 1247-2014: Translated English of Chinese Standard. (YYT 1247-2014, YY/T1247-2014, YYT1247-2014): Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)
This Standard specifies the technical requirements, test method, marks, labels, instructions, packaging, transportation, and storage of the hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay).
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according to formula Beijing Between-batch difference Calculate the average Calculate the coefficient calibrated by national chemiluminescent immunoassay coefficient of variation Coincidence rate expired-sample to perform GB/T HBsAg or precision hepatitis B virus higher than 0.1 higher than 15 instructions Judge according limit of HBsAg limit USE national manufacturing enterprise material USE national materials 1 IU/mL materials or negative materials or positive materials or precision materials to perform materials to test measurement results meet the requirements Minimum detection limit national reference materials national verification requirement negative reference material Operate according packaging specifications perform the detection perform the test positive reference materials precision reference materials Qualitative determination reagent rate of negative rate of positive reference materials HBsAg Repeatability USE national requirements of 3.1.9 requirements of manufacturing result shall meet sample signal standard deviation SD TAKE the expired-sample test 3 sets test result test the national tested according variation CV virus surface antigen