YY/T 1582-2018Colloidal gold immunochromatography reader (English PDF)
胶体金免疫层析分析仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 24, 2018
Implementation date
March 1, 2019
Scope
YY/T 1582-2018 is the English-translated version of 胶体金免疫层析分析仪.
YY/T 1582-2018 is the Chinese pharmaceutical industry standard for the colloidal gold immunochromatography reader, the instrument that measures the intensity of the lines on a lateral flow strip instead of reading them by eye.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the stability and repeatability of the optical measurement, the accuracy of the quantification against reference cards, the carry-over, the warm-up, and the behaviour of the instrument with its reagent strips. Issued on 24 February 2018, it has applied since 1 March 2019.
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Document preview — YY/T 1582-2018
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Requirements5
- 4 Test method7
- 5 Labels and instructions for use11
- 6 Packaging, transportation and storage12
- Appendix A (Informative) Preparation and measurement calibration method of quality control strip References14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of colloidal gold immunochromatography analyzers.
This standard is applicable to instruments that interpret the results of samples by measuring the reflectivity of the bands in the reaction zone of the colloidal gold reagent card (hereinafter referred to as analyzers).
This standard does not apply to instruments that use fluorescent labels or other labeling methods for rapid immunoassay.
2 Normative references
The following documents are indispensable for the application of this document.
For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
3 Requirements
3.1 Appearance
The following requirements shall be met when applicable.
3.2 Resolution
It may choose one of the following methods.
3.3 Accuracy
According to the following priority order, one of the following methods can be selected.
3.4 Repeatability
It may choose one of the following methods.
3.5 Linearity
It may choose one of the following methods.
3.6 Channel consistency (if applicable)
Test the quality control strip, the relative range (Rp) of the measurement results of each channel shall not be greater than 5%.
3.7 Stability
Test the quality control strip, the relative range (R) shall not exceed 5%.
3.8 Function
At least the following functions shall be included; the enterprise shall also determine other functions according to the characteristics of the product.
3.9 Safety requirements
It shall meet the requirements of applicable clauses in GB 4793.1, GB 4793.9, YY 0648.
4 Test method
4.1 Normal working conditions
4.1.5 The reflectivity of the quality control strip used in the test methods of 4.3, 4.4, 4.5, 4.6, 4.7 shall be traceable with reference to the method described in Appendix A; the preparation and assignment methods shall be clearly defined.
4.2 Appearance
Visual inspection with normal vision or corrected vision under natural light shall meet the requirements of 3.1.
4.4 Accuracy
4.4.1 Relative deviation
Use matching reagents to test certified reference materials. The measured value is recorded as (Xi). Use the formula (1) to respectively calculate the relative deviation B. If the three measurement results meet the requirements of 3.3a), it is deemed qualified. If more than or equal to 2 measurement results do not meet, it is judged as unqualified. If one measurement does not meet the requirements, it shall make 20 tests continuously again; use the formula (1) to calculate the relative deviation. If greater than or equal to 19 measurement results meet the requirements of 3.3a), it is judged as qualified.
4.5 Repeatability
4.5.1 Test quality control strip
Test the 3 quality control strips with high, medium and low reflectivity in the reflectivity range of [0.20, 0.80]; repeat the measurement 10 times; calculate the average (M) and standard deviation (SD) of the 10 measurement results; calculate the coefficient of variation (CV) according to formula (2), which shall meet the requirements of 3.4a).
4.6 Linearity
4.6.1 Test quality control strip
Test at least 5 quality control strips with evenly distributed reflectivity in [0.20, 0.80]; each quality control strip is tested 3 times; use the formula (3) to calculate the correlation coefficient (r) of linear regression, which shall meet the requirements of 3.5a).
4.7 Channel consistency (if applicable)
Test the quality control strip which has a reflectivity range of [0.30, 0.40]; measure the same quality control strip 3 times for each channel. Calculate the arithmetic average () and total average () of the measured values of each channel. Use formula (4) to calculate the relative range (Rp) of the measurement results of each channel, which shall meet the requirements of 3.6.
4.8 Stability
Test the quality control strip which has a reflectivity signal value within the measurement range of the instrument.
4.9 Function
Perform verification in accordance with the instructions and it shall meet the requirements of 3.8.
4.10 Safety requirements
Perform test according to the method specified in GB 4793.1, GB 4793.9, YY 0648, the results shall meet the requirements of 3.9.
4.11 Electromagnetic compatibility
Perform test according to the method specified in GB/T 18268.1 and GB/T 18268.26, the results shall meet the requirements of 3.10.
4.12 Environmental test
Perform test according to the method specified in GB/T 14710, the results shall meet the requirements of 3.11.
5 Labels and instructions for use
5.1 General
It shall meet the requirements of GB/T 29791.3.
5.2 Label
The analyzer's label shall be clearly attached in a prominent position and provide at least the following information.
5.3 Instruction manual
The instruction manual shall meet the requirements of the Provisions on the Administration of Medical Device Instructions and Labels; it shall at least include the following.
6 Packaging, transportation and storage
6.1 Packaging
The packaging shall meet the following requirements.
6.2 Transportation
Transport in accordance with the requirements set by the manufacturer.
6.3 Storage
Store it in accordance with the requirements specified by the manufacturer.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB 4793.9Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 18268.1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
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Related Standards
GB 4793.1-1995 — Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General requirements
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB 4793.9-2013 — Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
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