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YY/T 1160-2021: Carcinoembryonic antigen testing kit
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1160-2021	English	159	Add to Cart	3 days [Need to translate]	Carcinoembryonic antigen testing kit
YY/T 1160-2009	English	135	Add to Cart	0--9 seconds. Auto-delivery	Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)

YY/T 1160-2021: Carcinoembryonic antigen testing kit

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Carcinoembryonic antigen testing kit ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 1160-2009 Carcinoembryonic Antigen (CEA) Assay Kit Published on 2021-12-06 2022-12-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Principles of Standardization Documents" drafted: This document replaces YY/T 1160-2009 "Carcinoembryonic Antigen (CEA) Quantitative Determination Reagent (Kit) (Chemiluminescence Immunoassay)", and Compared with YY/T 1160-2009, in addition to editorial changes, the main technical changes are as follows: --- Changed the standard scope (see Chapter 1, Chapter 1 of the:2009 edition); --- Added normative references GB/T 191, GB/T 29791:2 (see Chapter 2); ---Increase the detection limit, linearity of the measurement system in terms and definitions, delete the minimum detection limit, analysis specificity (see Chapter 3, Chapter 3 of the:2009 edition); --- Changed the requirements for accuracy and the corresponding detection methods (see 5:3 and 6:3, 5:3 and 6:3 of the:2009 edition); --- Changed the detection limit requirements and corresponding detection methods (see 5:4 and 6:4, 5:4 and 6:4 of the:2009 edition); --- Changed the linearity requirements and the corresponding detection methods (see 5:5 and 6:5, 5:5 and 6:5 of the:2009 edition); --- Deleted the product inspection rules (see Chapter 7 of the:2009 edition); --- Changed the provisions of labels and instructions for use (see Chapter 7, Chapter 8 of the:2009 edition); --- Increased packaging should comply with the provisions of GB/T 191 (see 8:1): Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: Beijing Medical Device Inspection Institute, Kemei Diagnostic Technology Co:, Ltd:, Beijing Huaketai Biotechnology Co:, Ltd: Co:, Ltd:, Roche Diagnostics (Shanghai) Co:, Ltd: The main drafters of this document: Sun Li, Zhu Jinsheng, Wang Jianmei, Xiao Yi, Cai Xiaorong: The previous versions of this document and its superseded documents are as follows: ---First published in:2009 as YY/T 1160-2009; ---This is the first revision: Carcinoembryonic Antigen (CEA) Assay Kit

1 Scope

This document specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation of carcinoembryonic antigen (CEA) assay kits and storage, etc: This document is applicable to kits for quantitative determination of carcinoembryonic antigens based on the double-antibody sandwich method, including chemiluminescence, electrochemiluminescence, fluorescence Luminescence immunoassay kits and enzyme-linked immunosorbent assay kits for light and other labeling methods: This document does not apply to various carcinoembryonic antigen radioimmunization or immunoradiation kits labeled with radioisotopes such as 125I:

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 191 Graphical signs of packaging, storage and transportation GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices origin GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 chemiluminescence; CL Because the chemical reaction produces substances whose electronic energy levels are in an excited state, the latter releases energy through transitions to generate photons, resulting in luminescence: Phenomenon: 3:2 chemiluminescentimmunoassay; CLIA A technology that combines chemiluminescence and immunoassay, through a series of immunoreactions between labeled antigens or antibodies and the analyte, the most Then, the content of the analyte is obtained by measuring the luminescence intensity: 3:3 Detection limit detectionlimit; limitofdetection The measured value obtained by a given measurement procedure, for which, given the probability of misjudgment of the presence of a component in the claimed substance is α, the claim The probability of misjudgment in the absence of this component is β: Note 1: The International Union of Pure and Applied Chemistry (IUPAC) recommends that the default values of α and β be equal to 0:05: Note 2: It is used to describe a test procedure with a specific confidence level can be reported as the existence of the lowest measured value, also refers to the minimum detectable concentration: Note 3: It was also called "minimum detection limit", "minimum detection limit" and "detection limit": [Source: GB/T 29791:1-2013, A:3:14] ...