YY/T 1240-2023 (YY/T1240-2023, YYT 1240-2023, YYT1240-2023)
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(D-dimer assay kit (immunoturbidimetric method))
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YY/T 1240-2023
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Standards related to: YY/T 1240-2023
| Standard ID | YY/T 1240-2023 (YY/T1240-2023) | | Description (Translated English) | (D-dimer assay kit (immunoturbidimetric method)) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 14,132 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2023-07-15 | | Drafting Organization | The First Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing Institute of Medical Device Inspection, Beijing Medical Device Evaluation and Inspection Center, Jilin Provincial Drug Evaluation Center, Shandong Aikeda Biotechnology Co., Ltd., Sysmex Medical Electronics ( Shanghai) Co., Ltd., Beijing Stargao Diagnostic Products Trading Co., Ltd., Beijing Secside Technology Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, signs, labels and instructions for use, packaging, transportation and storage of D-dimer assay kit (immunoturbidimetric method). This standard applies to kit products for the determination of D-dimer by immunoturbidimetric method. | YY/T 1240-2023
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 1240-2014
D-dimer Assay Kit
D-dimer testing kit
Released on 2023-01-13
2023-07-15 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document replaces YY/T 1240-2014 "D-dimer quantitative detection reagent (box)", compared with YY/T 1240-2014, except for the structure
In addition to reconciling editorial changes, the main technical changes are as follows.
a) the name of the standard has been changed;
b) Added blank limit requirements (see 4.2);
c) The test interval is renamed linear, and the deviation is expressed in segments (see 4.3, 4.3 of the.2014 edition);
d) In the precision test method, the concentration range of low-value quality control or plasma sample and high-value quality control or plasma sample is clearly defined (see 5.5,
5.5 of the.2014 edition);
e) In the repeatability, the requirement that the product is used for the exclusion of venous thromboembolism (VTE) in patients with low pretest probability is added (see
4.4.1,.2014 version of 4.4.1);
f) Increased accuracy requirements (see 4.5);
g) Simplified the presentation of the reporting method (see 4.7, 4.6 of the.2014 edition);
h) YY/T 0466.1 is used instead of GB/T 191 for signs and labels (see 7.1, 7.1 of the.2014 edition);
i) The original 4.2 Negative Prediction Rate requirements are deleted and added to the chapter "Signs, Labels and Instructions for Use" (see Chapter 6,.2014 Edition
Chapter 6);
j) According to the performance characteristics of D-dimer reagents in Appendix B "Applicability of D-dimer reagents", its clinical application can be
Will be divided into three categories merged into two categories (see Appendix B, Appendix B of the.2014 edition).
Please note that some contents of this document may refer to patents. 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 Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This document was drafted by. The First Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing Institute of Medical Device Testing, Beijing Medical
Device Evaluation and Inspection Center, Jilin Provincial Drug Evaluation Center, Shandong Aikeda Biotechnology Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd.
Co., Ltd., Beijing Stargao Diagnostic Products Trading Co., Ltd., Beijing Secside Technology Co., Ltd., Shenzhen Mindray Biomedical
electronics co., ltd.
The main drafters of this document. Li Mianyang, Xu Yong, Sun Rong, Liu Liu, Di Ping, Li Jian, Li Tan, Guo Xin, Ding Chonghui, Zhao Yumei.
The release status of previous versions of this document and the documents it replaces are as follows.
---First released in.2014 as YY/T 1240-2014;
--- This is the first revision.
D-dimer Assay Kit
(Immunoturbidimetry)
1 Scope
This document specifies the requirements, test methods, signs, labels and instructions for use of the D-dimer assay kit (immunoturbidimetric method), package
Packing, transportation and storage.
This document is applicable to the kit products for the determination of D-dimer by immunoturbidimetric method (hereinafter referred to as D-dimer reagent).
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2.In vitro diagnostic reagents for professional use
YY/T 0466.1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1.General Requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Uniform latex particles coated with monoclonal antibody and soluble fibrin degradation products with DD epitopes in plasma
The heterosexual combination makes the latex particles stick to each other, and the degree of agglutination is proportional to the concentration of D-dimer in the specimen. At a certain wavelength, the pass
The amount of D-dimer is obtained by measuring the change in transmitted or scattered light caused by agglutination.
4 requirements
4.1 Appearance
Appearance should meet the following requirements.
a) The appearance of the kit should be neat and tidy, and the text and symbols should be clearly marked;
b) The D-dimer latex reagent should be a uniform emulsion (this requirement should be met after the dry powder reagent is reconstituted);
c) The D-dimer buffer is a clear solution without precipitates or flocs.
4.2 Blank limit
The blank limit of the D-dimer reagent should not exceed 0.25 μg/mL.
4.3 Linearity
In the linear range, the linear correlation coefficient should be greater than 0.980.The linear range covers at least that provided by the manufacturer for venous thromboembolism
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