YY/T 1713-2020 Translated English of Chinese Standard. (YYT 1713-2020, YY/T1713-2020, YYT1713-2020): Diagnostic kit for colloidal gold immunochromatographic assayThis Standard specifies relevant terms and definitions, requirements, test methods, labels and instructions for use, packaging, transportation and storage of diagnostic kit for colloidal gold immunochromatographic assay. This Standard is applicable to diagnostic kit that uses the colloidal gold immunochromatographic assay as the principle to conduct quantitative, semiquantitative, qualitative examinations to human sample. |
Common terms and phrases
according to 5.2.5 Analytical specificity assignment method Batch-to-batch difference Extract caliper to measure certified reference materials clinical sample coefficient of variation coincidence rate colloidal gold concentration/level setting content when applicable cutoff diagnostic kit diluent dose hook effect examination results Examine according Examine the negative expiry date Extract 3 batches Film strip width follow the following following principles High dose hook indicated concentration/level least meet limit of detection limit or deviation Liquid moving speed manufacturer shall specify manufacturer's claim meet the requirements microorganism month for testing negative and weakly negative reference product/sample NOTE number of liquid observation area Opening stability period and place positive reference products/samples preparation method reference product/sample containing reference products relative deviation requirements of 4.1.5 requirements of 4.2.5 Respectively examine result shall meet Rewrite GB/T specificity when applicable specified storage conditions Stability of validity temperature specified Thermal stability Take validity period variation CV Vernier caliper weakly positive reference