YY/T 1790-2021Fibrin/fibrinogen degradation products testing kit (latex immunoturbidimetry) (English PDF)
纤维蛋白/纤维蛋白原降解产物测定试剂盒（胶乳免疫比浊法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2023
Scope
YY/T 1790-2021 is the English-translated version of 纤维蛋白/纤维蛋白原降解产物测定试剂盒（胶乳免疫比浊法）.
YY/T 1790-2021 is the Chinese pharmaceutical industry standard for the kit that measures fibrin and fibrinogen degradation products by latex-enhanced immunoturbidimetry, where antibody-coated latex particles react with the FDP in the sample and the change in turbidity is read.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance, the traceability of the calibrator, accuracy, linearity, the detection limit, precision, the prozone effect at high concentrations, interference and stability. Issued on 6 September 2021, it has applied since 1 September 2023.
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Document preview — YY/T 1790-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Requirements
- 4 Test method
- 5 Logos, labels and instructions for use
- 6 Packaging, transport and storage3 Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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%.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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