YY/T 1160-2021 (YY/T1160-2021, YYT 1160-2021, YYT1160-2021)
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Carcinoembryonic antigen testing kit
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YY/T 1160-2021
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Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
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YY/T 1160-2009
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Standards related to: YY/T 1160-2021
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 | Classification of International Standard | 11.100.10 | Word Count Estimation | 8,885 | Date of Issue | 2021-12-06 | Date of Implementation | 2022-12-01 | Older Standard (superseded by this standard) | YY/T 1160-2009 | Quoted Standard | GB/T 191; GB/T 21415; GB/T 29791.2 | Drafting Organization | Beijing Medical Device Inspection Institute | Administrative Organization | National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System | Regulation (derived from) | Announcement No. 144 of 2021 of the State Drug Administration | Proposing organization | State Drug Administration | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of carcinoembryonic antigen (CEA) assay kits. This standard applies to kits for quantitative determination of carcinoembryonic antigens based on the double antibody sandwich method, including chemiluminescence, electrochemiluminescence, fluorescence and other labeling methods for luminescence immunoassay kits and enzyme-linked immunosorbent assay kits. This standard does not apply to various types of carcinoembryonic antigen radioimmunization or immunoradiation kits labeled with radioisotopes such as 125I. |
YY/T 1160-2021
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]
YY/T 1160-2009
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Carcinoembryonic Antigen Quantitative Detection
Reagent (Kit)
(Chemiluminescent Immunoassay)
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1,2011
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Classifications ... 6
5 Requirements ... 6
6 Test methods ... 7
7 Product inspection rules ... 9
8 Marks, labels and instructions ... 10
9 Packaging, transportation and storage ... 12
Bibliography ... 13
Foreword
The preparation of this Standard follows the basic regulations of the GB/T 1.1-2000 Directives for
Standardization. Part 1. Rules for the Structure and Preparation of Standards. It is the basis for
evaluating the product quality of carcinoembryonic antigen quantitative determination reagent (kit)
(chemiluminescent immunoassay).
This Standard was proposed by the China Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Medical Clinical Testing Laboratory
and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136).
Participating drafting organizations of this Standard. Beijing Institute of Medical Device Testing,
Beijing Chemclin Biotech Co., Ltd., Beijing Yuande Biomedical Engineering Co., Ltd., Roche
Diagnostic Products (Shanghai) Co., Ltd., and Beckman Coulter Co., Ltd.
Main drafters of this Standard. Zhang Xinmei, Cheng Yinghao, Sun Xudong, Hu Guomao, Ying
Xitang, Cai Xiaorong, and Zhang Jinwen.
Carcinoembryonic Antigen Quantitative Detection Reagent (Kit)
(Chemiluminescent Immunoassay)
1 Scope
This Standard specifies the terms and definitions, classification, requirements, test methods,
inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of
carcinoembryonic antigen (CEA) quantitative determination reagent (kit) (chemiluminescent
immunoassay).
This Standard applies to the quantitative determination of human carcinoembryonic antigen (CEA)
quantitative detection reagent (kit) (hereinafter referred to as "CEA reagent (kit)") based on the
principle of chemiluminescent immunoassay. It includes enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (box) with carriers such as microplates, pipes,
magnetic particles, microbeads, and plastic beads.
The Standard is not applicable to the requirements to the calibration products and quality control
products in the kit.
2 Normative references
The articles contained in the following documents have become part of this Standard when they
are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections)
or revisions made thereafter shall not be applicable to this Standard. For the undated documents
so quoted, the latest editions shall be applicable to this Standard.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and control
materials (ISO 17511.2003, IDT)
3 Terms and definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1
Chemiluminescence, CL
It refers to the luminescence phenomenon – because the chemical reaction can generate the
substances of which the electronic energy level is in the excited state; the electrons can generate
photons and release energy through transition; therefore it causes the luminescence
CALCULATE the mean. USE the Least Square Method to perform the straight-line fitting for the
results’ mean and dilution proportion. CALCULATE the linear correlation coefficient r. The result
shall comply with the requirements of 5.5.
6.6 Repeatability
Each sample of 10ng/mL±2ng/mL and 100ng/mL±20ng/mL is repeatedly tested for 10 times.
CALCULATE the mean M and standard deviation SD of the 10 measurement results. Coefficient of
variation CV is calculated from Equation of CV=SD/M×100%. The results shall comply with the
requirements of 5.6.
6.7 Difference between batches
Repeatedly USE 3 batches of kits to test the same-sample with concentration of
100ng/mL±20ng/mL for 10 times. CALCULATE the mean M and standard deviation SD of 30-times
measurement results. CALCULATE the coefficient of variation CV from Equation CV=SD/M×100%.
The results shall comply with the requirements of 5.7.
6.8 Stability
a) Stability within the validity. TAKE the after-expired sample. PERFORM the detection
according to the methods of 6.3, 6.4, 6.5 and 6.6. It shall comply with the requirements of
5.8 a).
b) Thermal stability test. TAKE the within-validity sample. PLACE for 3 days at 37°C.
PERFORM the detection according to the methods of 6.3, 6.4, 6.5 and 6.6. It shall comply
with the requirements of 5.8 b).
7 Product inspection rules
7.1 General provisions
CEA reagent (kit) must be submitted for inspection in batches. Inspection is divided into ex-factory
inspection and type inspection.
7.2 Reagent (kit) must be delivered to the Quality Inspection Department for inspection. It can be
sold only after inspection is qualified.
7.3 Reagent (kit) must be submitted for ex-factory inspection in batches. Each material-feeding
batch is deemed as 1 batch of products.
7.4 Ex-factory inspection
7.4.1 Amount of sampling
The amount of sampling of ex-factory inspection shall be 3 times of the amount of inspection items,
including the amount of inspection, amount of re-inspection and the amount of retained sample.
b) Name, address and contact information of manufacturing enterprise;
c) Medical device registration certificate number and product standard number;
d) Product batch number;
e) Period of validity;
f) Storage conditions.
8.2 Each constituent of reagent (kit)
It shall contain at least the following contents.
a) Product name and specifications;
b) Name or marks of manufacturing enterprise;
c) Product batch number;
d) Period of validity.
8.3 Operating instructions of reagent (kit)
It shall contain at least the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Inspection principle;
e) Main compositions;
f) Storage conditions and period of validity;
g) Applicable instrument;
h) Sample requirements;
i) Inspection methods;
j) Reference value (reference range);
k) Interpretation of the inspection results;
l) Limitations of inspection methods;
Bibliography
1) GB/T 191 Packaging - Pictorial marking for handling of goods
2) GB/T 9969 General principles for preparation of instructions for use of industrial products
3) YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling
and information to be supplied (ISO 15223-2000, IDT)
4) GB/T 19702-2005 In vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin - Requirements for content and presentation of reference
measurement procedures (ISO 15193.2002, IDT)
5) ISO/DIS 18113-1 Clinical laboratory testing and in vitro diagnostic medical systems -
Information supplied by the manufacturer (labelling) - Part 1. Terms, definitions and general
requirements
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