Standard Number: YY/T 1664-2019(YY/T1664-2019)
Chinese:甲状旁腺激素测定试剂盒
English:Parathyroid hormone detection kit
Effective Date:2020-08-01
ICS:11.040.30
Standard Applicability:This standard specifies the classification, requirements, test methods, labeling and instructions for use, packaging, transportation and storage of parathyroid hormone (PTH) determination kits. This standard applies to the double antibody sandwich method for the principle of quantitative determination of the whole parathyroid hormone (1-84) kit, including enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescence labeling and other labeling methods of immunoassay kits. This standard does not apply to the reagents for semi-quantitative determination of the whole parathyroid hormone (1-84) labeled with colloidal gold or other methods (e.g., test strips, etc.); and various types of parathyroid hormone radioimmunoassay or immunoradiotherapy kits labeled with radioisotopes such as 125I.
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