YY/T 1645-2019Detection kit for IgG antibody to human parvovirus B19 (English PDF)

3.1 Appearance

The appearance should meet the following requirements.

a) The components of the kit should be complete and complete, and the liquid should be free of leakage;

b) Chinese packaging labels should be clear and free of wear.

3.2 Positive reference product compliance rate

Test with a national positive reference or a standardized positive reference, the results should meet the requirements of the corresponding reference.

3.3 Negative reference product compliance rate

Test with a national negative reference or a standardized negative reference, the results should meet the requirements of the corresponding reference.

3.4 Minimum detection limit

Use international reference products, national minimum detection limit reference products or standardized minimum detection limit reference products, no higher than 7IU/mL The concentration of the reference should be detectable as positive.

3.5 Repeatability

Detection with a national repetitive reference product or a standardized repetitive reference product, the results should be human parvovirus B19 IgG antibody positivity Sex, the coefficient of variation (CV, %) of the measured value should be no more than 15.0%, and the chemiluminescence method should be no more than 10.0%.

Note. Measurement values include, but are not limited to, OD value, luminescence value, concentration, and the like.

3.6 Inter-batch difference

National repetitive reference or standardized repetitive reference is tested with 3 batch kits, inter-assay variants of measured values