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YY/T 1741-2021: Antithrombin III testing kit
Status: Valid YY/T 1741: Evolution and historical versions
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Antithrombin III testing kit
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YY/T 1741-2021
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| YY/T 1741-2021 | English | 159 |
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Antithrombin III testing kit
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YY/T 1741-2021
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PDF similar to YY/T 1741-2021
Basic data | Standard ID | YY/T 1741-2021 (YY/T1741-2021) | | Description (Translated English) | Antithrombin III testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.040 | | Word Count Estimation | 8,824 | | Date of Issue | 2021-03-09 | | Date of Implementation | 2023-04-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of antithrombin III assay kits. This standard applies to kits for the determination of antithrombin III activity by the chromogenic substrate method (hereinafter referred to as the kit), and does not apply to kits for the determination of the mass concentration of antithrombin III by turbidimetric methods. | YY/T 1741-2021: Antithrombin III 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.
ICS 11:040
C44
Pharmaceutical Industry Standard of the People's Republic of China
YY 1741-2021
Antithrombin III Assay Kit
Antithrombin III testing kit
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on 2021-03-09
2023-04-01 Implementation
Released by the State Drug Administration
foreword
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee:
This standard was drafted by: General Hospital of the Chinese People's Liberation Army, Beijing Seikexide Technology Co:, Ltd:, Beijing Medical Device Inspection
Institute, Shanghai Changdao Biotechnology Co:, Ltd:, Sysmex Medical Electronics (Shanghai) Co:, Ltd:, Roche Diagnostics (Shanghai) Co:, Ltd:, Mai
Gram Biological Co:, Ltd:
The main drafters of this standard: Li Jian, Ding Chonghui, Xu Yong, Xu Han, Lei Ting, Zhang Shuang, Tian Wei, Chen Qiyun:
YY 1741-2021
Introduction
In 1954, Seegers et al: first divided antithrombin into four types, and since then, the name of antithrombin III has been used: international health organization
(WHO) established the first generation of international reference material (72/1) in 1978, which used the name of antithrombin Ⅲ: by the UK National Biological
The second generation of international reference materials (93/578) prepared by NIBSC and established by WHO in:1994, the third generation of national reference materials in:2010
The international reference product (08/258) no longer uses the nomenclature of "antithrombin III", but uses the nomenclature of "antithrombin": International Thrombosis and Hemostasis
Antithrombin (ISTH) is also the term nomenclature: There are two types of products listed in the domestic market: antithrombin III assay kit and
Antithrombin Assay Kit: Although the terminology and the names of international reference products have been unified internationally, in view of the fact that the names of international products use
According to the actual registration situation of domestic products, antithrombin III is still used in the name of this standard:
The international unit of plasma antithrombin was established through a multi-center joint study based on the assignment of normal pooled plasma from each laboratory
of: Each laboratory's pooled normal plasma was defined as 1 IU, and the public mean was assigned to the standard: Currently, many coagulation diagnostic products
Manufacturers use "%" values in their calibration plasma, where 100% is equivalent to 1 IU, and in their calibration plasma and/or diagnostic kits:
marked in the relevant documentation: Therefore, the use of "%" for plasma calibration or quality control is perfectly acceptable:
YY 1741-2021
Antithrombin III Assay Kit
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of antithrombin III assay kits:
This standard applies to the antithrombin III assay kit (hereinafter referred to as the kit) based on the chromogenic substrate method of heparin cofactor activity, not
A kit suitable for measuring the mass concentration of antithrombin III by turbidimetry:
2 Normative references
The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this
document: For undated references, the latest version (including all amendments) applies 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
3 requirements
3:1 Appearance
Appearance should meet the following requirements:
a) The components of the kit should be complete and complete without leakage, and the labels should be clear and easy to identify;
b) The liquid reagent should be a homogeneous solution;
c) The lyophilized product is a homogeneous solution after reconstitution:
3:2 Capacity
The filling volume of the liquid properties reagent should not be less than the marked value:
3:3 Linearity
The linearity of the kit covers at least 20%~140%: In the linear interval, the slope of the linear regression equation is in the range of 1±0:05, and the correlation
Coefficient r≥0:980:
3:4 Repeatability
The repeatability test uses samples at three concentration levels: high, medium, and low: The coefficient of variation (CV) of high-concentration samples should be ≤10%, and that of medium
The coefficient of variation (CV) should be ≤10%, and the coefficient of variation (CV) for low-concentration samples should be ≤15%:
3:5 Accuracy
Select one of the following substances to repeat the test three times, and calculate the relative deviation respectively, and the relative deviation should not exceed ±15:0%:
a) Adopt recognized reference material or certified reference material (CRM);
b) Adopt corporate reference materials traceable to recognized reference materials or certified reference materials:
3:6 Detection limit
The detection limit should not exceed 20%:
YY 1741-2021
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