YY/T 1240-2023_English: PDF (YY/T1240-2023)
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(D-dimer assay kit (immunoturbidimetric method))
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| 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. | | Standard ID | YY/T 1240-2014 (YY/T1240-2014) | | Description (Translated English) | D-Dimer reagent (kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 12,193 | | Date of Issue | 2014/6/17 | | Date of Implementation | 2015/7/1 | | Quoted Standard | GB/T 191; GB 3100; GB 3101; GB 3102.1; GB 3102.2; GB 3102.3; GB 3102.4; GB 3102.5; GB 3102.6; GB 3102.7; GB 3102.8; GB 3102.9; GB 3102.10; GB 3102.11; GB 3102.12; GB 3102.13; YY/T 0466.1 | | Drafting Organization | PLA General Hospital | | Administrative Organization | National medical clinical testing laboratory and in vitro diagnostic systems Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to laboratory with immune nephelometry D- dimer quantitative detection reagent (box) products. This Standard specifies the D- dimer quantitative detection reagent (box) of terminology, definitions, requirements, test methods, marking |
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
......
YY/T 1240‐2014
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
D-Dimer reagent (kit)
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
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 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 8
7 Packaging, transportation and storage ... 10
Annex A (Informative) The application of patient assessment and pre-test
probability ... 12
Annex B (Informative) Applicable instructions about D-Dimer ... 13
Bibliography ... 15
Foreword
This 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.
The 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. People’s Liberation Army General Hospital, Beijing
Institute of Medical Device Testing, Beijing Success Technology Development Co., Ltd,
and Werfen Medical Device International Trading (Shanghai) Co., Ltd.
The main drafters of this Standard. Li Jian, Bi Chunlei, Ding Chonghui, and Yu Hui.
D-Dimer reagent (kit)
1 Scope
This Standard specifies the term and definition, requirements, test methods, symbols,
labels and instructions, packing, transportation, and storage of D-Dimer quantitative
detection reagent (kit).
This Standard applies to immunoturbidimetric D-Dimer reagent (kit) (hereinafter referred
to as D-D reagent) used in laboratory.
2 Normative references
The 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 191 Packaging - Pictorial marking for handling of goods
GB 3100 The international system of units and its application
GB 3101 General principles concerning quantities, units and symbols
GB 3102 (All parts) Quantities and Units
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
3 Terms and definitions
For the purpose of this Document, the following terms and definitions apply.
3.1
immunoturbidimetric D-dimer assay
The homogeneous latex particles, coated by monoclonal antibody, COMBINE with the
degradation product’s specificity of the soluble fibrin of D-D antigen determinants in
plasma. So that it makes the latex particles to coagulate each other. The coagulation
degree is proportional to the concentration of D-Dimer in the specimen. At certain
5.7 Report pattern
VERIFY the reporting template. It shall meet the requirements specified in 4.6.
6 Marks, labels and instructions
6.1 General requirements
The general requirements of symbols, labels and instructions are as follows.
a) The form and content of the labels and instructions shall adapt to the expected uses
of the reagent (kit);
b) Use the symbols specified in YY/T 0466.1. If there is no relevant standard or users
fail to understand the symbols used, those symbols and colors shall be explained in
the instructions;
c) The numerical unit provided shall be understood by users. Use the symbols
specified in GB3100-3102;
d) The microbiological status of the product shall be explained when using the product;
e) Unless it is easy to know how to use the reagent (kit), there shall have instructions.
— There shall have relevant instructions or symbols to prompt users to carefully
read the instructions before using the reagent (kit);
— The language used in the instructions shall be understood by the expected
users;
f) Emphasize and prompt users the important changes of the reagent (kit) and the
position of the relevant information;
g) Warn users the possible risks and dangers by words or symbols;
h) The name, letter, number, symbol, color and graph of each component of the
reagent (kit) shall be marked in the same way;
i) The reagent instructions can be put in the packing as separated pages, which can
be on the external surface of the container, in the manual, in the operation manual,
or integrated with the instructions of the instruments or analyzing system.
j) The reagent instructions can be in electronic version.
k) Some of the instructions can be provided in a coded form, and be explained in the
system operation manual;
l) If there is no detailed instructions attached to the reagent (kit), the manufacturing
enterprise shall make sure that users can get a correct version of the reagent (kit)
instructions;
m) The labels of the exterior packing and initial packing shall include the required
information, which shall be described by intelligible words or symbols;
Examples. The quality, font and font size of the printing;
n) The labels and instructions provided with the reagent (kit) shall include how to
handle and store the reagent before using.
6.2 Labels for outer packing
The label in the exterior packing shall provide the following information.
a) Reagent name;
b) Packaging specifications;
c) IVD reagents;
d) Storage conditions;
e) Batch number;
f) Valid period;
g) Registration certificate number;
h) Product standard number;
i) Name and address of manufacturing enterprise.
6.3 Labels for inner packing
The label in the interior packing shall provide the following information.
a) Reagent name;
b) Packaging specifications;
c) Storage conditions;
d) Batch number;
e) Valid period;
f) Name of the manufacturing enterprise.
6.4 Operating instructions
B.2.3.3 When performing clinical assessment, the tested reagent shall be compared with
another D-dimer reagent system that has been confirmed by authentic institution and
possesses the VTE diagnosing function.
B.2.3.4 Negative predictive value (NPV) is 97% and above (lower limit of 95%
confidence interval is not lower than 95%). The auxiliary diagnosis has no specific
requirement to sensitivity.
B.2.4 Used for the exclusion diagnosis of VTE
B.2.4.1 Characteristics. The clinical doctor excludes the VTE through D-dimer
experiment, combining PTP.
B.2.4.2 The VTE-suspected patients are continuously selected in clinical research. It
shall be performed at 3 centers at least. The 3 centers use the same PTP principle. The
sample size possesses the statistical significance (Both incidences of DVT and
PE >10%).
B.2.4.3 The clinical assessment takes the imaging diagnosis result (clinical fact) as the
criterion. If the imaging diagnosis does not confirm VTE, then the patient will be traced for
3 months to confirm the negative result.
B.2.4.4 Negative predictive value (NPV) is 97% and above (lower limit of 95%
confidence interval is not lower than 95%). The sensibility is not lower than 95% (the lower
level of 95% confidence interval is not lower than 90%).
Bibliography
1) Huang Yueqin. Clinical Epidemiology. Beijing. People's Medical Publishing House,
2) Jack Hirsh, Agnes Y. Y. Lee. How we diagnose and treat deep vein thrombosis. Blood,
2002. 99. 3102-3110
3) Wells, P.s.., D.R. Anderson, et al. Evaluation of D-dimer in the diagnosis of suspected
deep-vein thrombosis. N Engl J Med. 2003; 349 (13). 1227-1235.
4) Clinical and Laboratory Standards Institute. Quantitative D-dimer for the Exclusion of
Venous Thromboembolic Disease; Approved Guideline. CLSI document H59-A(ISBN
1-56238-747-2)
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