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YY/T 1790-2021: (Fibrin/Fibrinogen degradation product determination kit (latex immunoturbidimetric method))
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1790-2021 | English | 199 |
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(Fibrin/Fibrinogen degradation product determination kit (latex immunoturbidimetric method))
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YY/T 1790-2021
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Basic data | Standard ID | YY/T 1790-2021 (YY/T1790-2021) | | Description (Translated English) | (Fibrin/Fibrinogen degradation product determination kit (latex immunoturbidimetric method)) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 9,957 | | Issuing agency(ies) | State Drug Administration | YY/T 1790-2021: (Fibrin/Fibrinogen degradation product determination kit (latex immunoturbidimetric method))
---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.
(Fibrin/Fibrinogen degradation product determination kit (latex immunoturbidimetric method))
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Fibrin/Fibrinogen Degradation Products
Assay Kit
(Latex immunoturbidimetric method)
Published on 2021-09-06
2023-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Requirements 1
4 Test method 2
5 Logos, labels and instructions for use3
6 Packaging, transport and storage3
Reference 4
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This standard was drafted by. Beijing Secex Technology Co., Ltd., Chinese People's Liberation Army General Hospital, Beijing Medical Device Inspection
Institute, Beijing Wantederui Diagnostic Technology Co., Ltd., Shanghai Changdao Biotechnology Co., Ltd., Zhonghan Shengtai Biotechnology Co., Ltd.,
Sammykang Medical Electronics (Shanghai) Co., Ltd., Shanghai Sun Biotechnology Co., Ltd.
The main drafters of this standard. Li Jian, Ding Chonghui, Li Zheng, Yuan Chengbin, Xiong Jiebing, Yan Huawen, Wang Zhong, Zhang Shuang, Xie Yonghua.
Fibrin/Fibrinogen Degradation Products
Assay Kit
(Latex immunoturbidimetric method)
1 Scope
This standard specifies the requirements, test methods, standards for the determination kits for fibrin/fibrinogen degradation products (latex immunoturbidimetry)
labeling, instructions for use, packaging, transportation and storage.
This standard applies to the use of latex-coated antibodies, which immunoreact with fibrin/fibrinogen degradation products in the sample to be tested.
A kit for determining the content of fibrin/fibrinogen degradation products by measuring the change in turbidity (hereinafter referred to as FDP kit).
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
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 Requirements
3.1 Appearance
The 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 buffer should be a homogeneous liquid;
c) The latex particle solution or the reconstituted solution of the lyophilized product is a homogeneous suspension.
3.2 Loading capacity
The amount of liquid reagents should not be less than the value indicated on the label of the reagent bottle.
3.3 Linear
Kit linearity covers at least [4,40] μg/mL. In the linear interval, the slope of the linear regression equation is in the range of 1±0.05, and the correlation
Coefficient r≥0.990.
3.4 Repeatability
Repeat the test for samples with high and low concentration levels, the coefficient of variation (CV) of low-concentration samples should be ≤ 15%, and the coefficient of variation of high-concentration samples should be less than or equal to 15%.
(CV) should be ≤10%.
3.5 Accuracy
The recovery rate was 100%±15%.
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