YY/T 1249-2014 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1249-2014YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD YY/T 1249-2014 Free prostate specific antigen quantitative labelling immunoassay kit Issued on. JUNE 17, 2014 Implemented on. JULY 1, 2015 Issued by. State Food and Drug Administration Table of Contents1 Scope... 4 2 Normative references... 4 3 Classification... 4 4 Requirements... 5 5 Test methods... 7 6 Marks, labels and instructions... 8 7 Packaging, transportation and storage... 10 Bibliography... 11ForewordThis Standard is drafted according to the rules specified in GB/T 1.1-2009. Please note that some contents of this Document may involve patents. The issuing authority of this Document does not undertake the responsibility of identifying these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC 136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China. Drafting organization of this Standard. National Institutes for Food and Drug Control. The main drafters of this Standard. Huang Ying, Zhang Chuntao, Shen Shu, Yu Ting, and Gao Shangxian. Free prostate specific antigen quantitative labelling immunoassay kit1 ScopeThis standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation, and storage of the free prostate specific antigen quantitative labelling immunoassay kit. This standard is applicable to the kit which quantitatively determines the free prostate specific antigen (fPSA) by the principle of double antibody sandwich method (hereinafter referred to as. fPSA kit). It includes the immunoassay kit of quantitative determination of fPSA by using labelling methods such as enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence labelling AS the capture antibody; and using carriers such as microplates, pipes, magnetic particles, microbeads, and plastic beads AS the coated antibody. This standard does not apply to. a) Reagent which is used to qualitatively or semi-quantitatively determine fPSA by colloidal gold or other methods (such as. test paper strip, etc.); b) Various types of fPSA radio-immunity or IRMA kit labelled with 125I and other radioactive isotopes.2 Normative referencesThe articles contained in the following documents have become part of this Document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document. GB/T 191 Packaging - Pictorial marking for handling of goods3 ClassificationAccording to different labelling method, fPSA kit can be divided into enzyme labelling fPSA kit, (electric) chemiluminescence labelling fPSA kit, (time-resolved) fluorescence labelling fPSA kit, etc.4 Requirements4.1 Appearance and physical examination The kits shall be completed in components. The internal and external package shall be intact. The label shall be clear. 4.2 Linearity Within the interval of 0.5 g/L~10 g/L, USE double logarithmic or other appropriate mathematical model for fitting. The linear correlation coefficient (r) of dose-response curve shall not be less than 0.9900. 4.3 Minimum detection limit It shall not be higher than 0.20 g/L. 4.4 Accuracy Calibrator in the kit AND fPSA national (or international) standard materials with corresponding concentrations are tested at the same time. USE double logarithmic or other appropriate mathematical model for fitting. 4.5 Precision 4.5.1 Within-analysis precision Coefficient of variation (CV) of measured results of control material of manual operation kit shall not be more than 15.0%; the coefficient of variation (CV) of measured results of control materials of full-automatic immune analysis system kit shall not be more than 8.0%. 4.6 The measured value of control materials For the kit equipped with fixed-value control materials, its determination result shall be in the range specified by the kit. 4.7 Specificity USE national (or international) standard materials of free prostate specific antigen taken AS the comparison materials. The determination result of national (or international) standard materials prostate specific antigen in this kit shall be consistent with its labelled ratio content. 4.8 Stability 4.8.1 Stability at the end of validity The kit is preserved until the end of the validity under a stated condition. The measured results shall comply with provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6.5 Test methods5.1 Appearance and physical examination The visual inspection under the natural light shall be in compliance with the provisions of 4.1.The redissolving time of freeze-dried products is measured with timer. 5.2 Linearity Dose - response curve linearity of the kit’s calibrator shall be in compliance with the provisions of 4.4.For those kits not equipped with calibrator, USE fPSA national (or international) standard materials (or other high concentration sample); PREPARE the proper concentration points (generally no less than 5 points), according to the linear range specified by the kit instructions. 5.3 Minimum detection limit Repeatedly TEST zero-calibrator (or diluent of sample) for not less than 10 times. Calculate the average value (x) and standard deviation (SD) of reaction volume (A or RLU or CPS, etc.). SUBSTITUTE the reaction volume of (x + 2SD) into dose-response curve. Calculate the corresponding concentration value. It shall comply with provisions of 4.3. 5.5 Precision 5.5.1 Within-analysis precision 2 ~ 3 control materials are set up in different areas of dose-response curves. Within a same-analysis, repeatedly measure each control materials for not be less than 8 times. The coefficient of variation (CV) of the measured results shall comply with provisions of 4.5.1. 5.6 The measured value of control materials Control materials (usually 2-3) are set up in different areas of dose-response curves. The measured results of the kit shall comply with the provisions of 4.6. 5.7 Specificity National (or international) standard materials of free prostate specific antigen (fPSA) AND national (or international) standard materials of prostate specific antigen (fPSA) are prepared to solutions with appropriate series of concentrations. 5.8 Stability After the kit is preserved at conditions specified by provisions of 4.8.1, 4.8.2 or 4.8.3, MEASURE 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6.The results shall comply with related provisions.6 Marks, labels and instructions6.1 Marks, labels of outer package of kit It shall contain at least the following contents. 6.2 Marks and labels of each component package of kit It shall contain at least the following contents. 6.3 Instructions of reagent (kit) It shall generally contain the following contents.7 Packaging, transportation and storage7.1 Packaging The kit shall be packed according to the requirements of product enterprise, and satisfy the requirements of GB/T 191. 7.2 Transportation Reagent (kit) shall be transported according to the requirements of manufacturing enterprise. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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