YY/T Translated English of Chinese Standard: YY/T PHARMACEUTICAL INDUSTRY STANDARD

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1 Translated English of Chinese Standard: YY/T Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 44 YY/T C-peptide quantitative labelling immunoassay kit C- 肽 (C-P) 定量标记免疫分析试剂盒 Issued on: March 28, 2017 Implemented on: April 1, 2018 Issued by: China Food and Drug Administration of China Buy True-PDF Auto-delivery. Page 1 of 10

2 Table of Contents Foreword Scope Normative references Classification Requirements Test methods Labels and instructions for use Packaging, transport and storage... 9 Bibliography Buy True-PDF Auto-delivery. Page 2 of 10

3 C-peptide quantitative labelling immunoassay kit 1 Scope This Standard specifies the classification, requirements, inspection methods, labels and instructions for use, packaging, transport and storage for C-peptide quantitative labelling immunoassay kit. This Standard is applicable to C-peptide quantitative labelling immunoassay kit (hereinafter referred to as the kit), including the C-peptide quantitative measuring immunoassay kit in Labeling methods such as enzyme labeling, chemiluminescent labeling, time-resolved fluorescent labeling, etc., using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191, Packaging and storage marks GB/T , In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use 3 Classification The kit can be divided into enzyme-linked immunosorbent assay, chemiluminescence assay, time-resolved immunofluorescence assay according to different labeling methods. According to different solid phase carriers, it can be divided into microplate, tube, magnetic particles, microbeads and plastic beads as carriers. According to different operating procedures, it can be divided into manual operation method kit and instrument automatic operation method kit. Buy True-PDF Auto-delivery. Page 4 of 10

4 Determine the human proinsulin at a concentration of 10 ng/ml, the determination result shall be no higher than 0.25 ng/ml. Determine the human insulin at a concentration of 500 μiu/ml, the determination result shall be no higher than 0.25 ng/ml. 4.7 Stability General Verify shelf life stability and thermal stability Shelf life stability The manufacturer shall specify the period of validity of the product. Get the product within a certain period of time after the expiration date to test reagent blank limit, linearity, accuracy, intra-assay precision, specificity. The inspection results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and Thermal stability Place the kit at 37 C for a certain period of time. Test reagent blank limit, linearity, accuracy, intra-assay precision, specificity. The test results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and Stability after lyophilization reagent reconstitution After the lyophilized component in the kit is reconstituted according to the specified conditions, it is allowed to stand at 4 C for a certain period of time. Test reagent blank limit, linearity, accuracy, intra-assay precision, specificity. The test results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and 4.6. NOTE 1: Thermal stability cannot be used to derive the expiration date of a product unless it is based on a derivation formula based on a large number of stability studies. NOTE 2: Generally, a product with a validity of one year is selected for no more than one month, a product with a validity period of no more than half a month for a half year, and so on. However, if the time exceeds the specified time, the product can be accepted when it meets the requirements. NOTE 3: If the kit contains components such as lyophilized calibrators and is stable after being reconstituted for a certain period of time, verification of is required. 5 Test methods 5.1 Appearance Visual inspection with normal or corrected visual acuity under natural light shall comply with the requirements of Buy True-PDF Auto-delivery. Page 6 of 10

5 Where, CV - coefficient of variation; s - standard deviation of 10 measurements; - average of 10 measurements Inter-assay precision Repeat the determination of different concentrations of quality control products 10 times with three different batch kits. Calculate the coefficient of variation of the 30 measurements according to equation (3), which shall meet the requirements of Where, CV - coefficient of variation; s - standard deviation of 30 measurements; - average of 30 measurements. 5.6 Specificity Determine human proinsulin at a concentration of 10 ng/ml and human insulin sample at a concentration of 500 μl/ml, once respectively. The measurement results shall meet the requirements of Stability After the kit is stored in accordance with the conditions specified in 4.7, the items of 5.2, 5.3, 5.4, 5.5.1, 5.6 shall be tested. The test results shall meet the requirements of Labels and instructions for use In accordance with the requirements of GB/T Buy True-PDF Auto-delivery. Page 8 of 10