YY/T 1247-2014 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 1247-2014: Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay) 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 1247-2014: Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)---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/YYT1247-2014 YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD YY/T 1247-2014 Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (Chemiluminescent immunoassay) Issued on. JUNE 17, 2014 Implemented on. JULY 1, 2015 Issued by. State Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Requirements... 4 4 Test methods... 8 5 Marks, labels and instructions... 11 6 Packaging, transportation and storage... 13 Bibliography... 14ForewordThis 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 organizations of this Standard. National Institutes for Food and Drug Control, Beijing Institute of Medical Device Testing, Beijing Chemclin Biotech Co., Ltd, Beijing Yuande Bio-Medical Engineering Co., Ltd, Roche Diagnostics (Shanghai) Ltd., and Abbott Trading (Shanghai) Co., Ltd. The main drafters of this Standard. Zhou Cheng, Wang Ruixia, Du Haiou, Cheng Yinghao, Cai Xiaorong, Wang Yunfeng, and Wang Xuefeng. Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (Chemiluminescent immunoassay)1 ScopeThis Standard specifies the technical requirements, test method, marks, labels, instructions, packaging, transportation, and storage of the hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to the reagent (kit) that utilizes the chemiluminescent analysis technique, and adopts the double antibody sandwich method to qualitatively or quantitatively measure the hepatitis B virus surface antigen (hereinafter referred as “HBsAg”) reagent (kit) in human’s serum and plasma. It includes chemiluminiscence, electrochemiluminescence and time-resolved fluorescence etc. This Standard does not apply to. a) The calibrator of surface antigen of hepatitis B virus that is marketed independently, and the quality control materials of surface antigen of hepatitis B virus; b) Biochip in the principle of chemiluminescent immunoassay.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 21415 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials3 Requirements3.1 Quantitative determination reagent (kit) 3.1.1 Appearance It shall meet the following requirements. 3.1.3 Accuracy When using the national reference materials HBsAg or the standard national reference materials as the sample to take the test, the relative deviation of test result shall be within the range of ±20%. 3.1.4 Coincidence rate of positive reference material USE national reference materials or positive reference materials that has been calibrated by national reference materials to perform the detection. It must not be negative. 3.1.6 Minimum detection limit USE national reference materials HBsAg or reference materials that has been calibrated by national reference materials to perform the detection. 3.1.7 Linearity The linear range specified by the manufacturing enterprise shall at least cover 5.9 IU/mL-100.0 IU/mL. Within the linear range specified by the manufacturing enterprise, the correlation coefficient r shall not be lower than 0.9900. 3.1.8 Precision 3.1.8.1 Repeatability USE national reference materials or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to repeatedly test for 10 times. Its coefficient of variation (CV) shall not be higher than 15%. 3.1.9 Stability The following methods can be used for verification. 3.2 Qualitative determination reagent (kit) 3.2.1 Appearance The following requirements shall be met. 3.2.2 Coincidence rate of positive reference material USE national reference materials or positive reference materials that has been calibrated by national reference materials to perform the test. It must not be negative. 3.2.3 Coincidence rate of negative reference material USE national reference materials or negative reference materials that has been calibrated by national reference materials to perform the test. It must not be positive. 3.2.5 Precision 3.2.5.1 Repeatability USE national reference materials or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to repeatedly test for 10 times. Its coefficient of variation (CV) shall not be higher than 15%. 3.2.6 Stability The following methods can be used for verification.4 Test methods4.1 Quantitative determination reagent (kit) 4.1.1 Appearance Visually inspect with normal vision under the natural light. It shall meet the requirements of 3.1.1. 4.1.5 Coincidence rate of negative reference material TEST 20 sets of national reference materials or negative reference materials that has been calibrated by national reference materials. Operate according to the reagent (kit) instructions’ steps. Judge according to the instructions. The result shall meet the requirements of 3.1.5. 4.1.6 Minimum detection limit TEST the national reference materials HBsAg or sensitivity reference materials that has been calibrated by national reference materials. Operate according to the reagent (kit) instructions’ steps. Judge according to the instructions. The result shall meet the requirements of 3.1.6. 4.1.8 Precision 4.1.9 Stability 4.1.9.1 Stability within the validity. Take the expired-sample to perform the test according to the methods of 4.1.3-4.1.8.1.It shall meet the requirements of 3.1.9 a). 4.1.9.2 Thermal stability test. The sample within the period of validity, according to thermal stability conditions provided by the manufacturing enterprise, shall be tested according to the methods of 4.1.3-4.1.8.1.It shall meet the requirements of 3.1.9 b). 4.2 Qualitative determination reagent (kit) 4.2.1 Appearance Visual inspect with normal vision under the natural light. It shall meet the requirements of 3.2.1. 4.2.2 Coincidence rate of positive reference material USE national reference materials or positive reference materials that has been calibrated by national reference materials to test 3 sets of HBsAg positive reference materials of which the concentration is higher than 5×104 IU/mL. Judge according to the instructions. The result shall meet the requirements of 3.2.2. 4.2.5 Precision 4.2.5.1 Repeatability USE national reference materials HBsAg or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to perform the test. Repeat the test for 10 times. USE the luminescent signal value of the sample OR the ratio (S/CO) of sample signal and Cut-off to calculate the average value (x) and standard deviation (SD) of the 10 times measurement results. Calculate the coefficient of variation (CV) according to formula (2). The result shall meet the requirements of 3.2.5.1. 4.2.6 Stability 4.2.6.1 Stability within the validity. Take the expired-sample to perform the test according to the methods of 4.2.2-4.2.5.1.It shall meet the requirements of 3.2.6 a). 4.2.6.2 Thermal stability test. The sample within the period of validity, according to thermal stability conditions provided by the manufacturing enterprise, shall be tested according to methods of 4.2.2-4.2.5.1.It shall meet the requirements of 3.2.6 b).5 Marks, labels and instructions5.1 Marks and labels for outer packing It shall contain at least the following contents. 5.2 Packaging marks and labels of each component It shall contain at least the following contents. 5.3 Operating instructions It shall contain at least the following contents.6 Packaging, transportation and storage6.1 Packaging It shall be packaged according to the requirements of manufacturing enterprise. 6.2 Transportation It 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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