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YY/T 1160-2021: Carcinoembryonic antigen testing kit
Status: Valid YY/T 1160: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1160-2021 | English | 159 |
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Carcinoembryonic antigen testing kit
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YY/T 1160-2021
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| YY/T 1160-2009 | English | 135 |
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Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
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YY/T 1160-2009
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PDF similar to YY/T 1160-2021
Basic data | Standard ID | YY/T 1160-2021 (YY/T1160-2021) | | Description (Translated English) | Carcinoembryonic antigen testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,842 | | Issuing agency(ies) | State Drug Administration | 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]
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