YY/T 1525-2017 English PDF (YYT1525-2017)

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YY/T 1525-2017: Test kit for methamphetamine (colloidal gold method)
YY/T 1525-2017
Test kit for methamphetamine (colloidal gold method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Methyl amphetamine test kit (colloidal gold method)
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute.
The main drafters of this standard. Zuo Ning, Chen Hua, Nan Nan.
Methyl amphetamine test kit (colloidal gold method)
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels, labels, and instructions for the methamphetamine test kit (colloidal gold method).
Instructions, packaging, transportation and storage.
This standard applies to the qualitative detection of methamphetamine (methamphetamine) in human urine by the principle of colloidal gold immunochromatography.
Detect kit for MET) and a combined test kit containing methamphetamine.
This standard does not apply to.
a) a test kit for non-human urine testing;
b) Kits tested by other methods.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2-2013 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional use for external diagnosis
Broken reagent
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Methamphetamine methamphetamine
CAS number. 537-46-2, molecular formula. C10H15N, also known as methamphetamine, methamphetamine. Including its optical isomers and various types
Salt type.
4 requirements
4.1 Physical properties
4.1.1 Appearance
The appearance should be flat, the material is firmly attached, the content is complete, and the inner package is clean, leak-free and damage-free.
4.1.2 Strip width
The width of the strip should be no less than 3mm.
4.1.3 Liquid migration speed
The liquid migration speed should be no less than 20mm/min.
4.2 Positive reference product compliance rate
Testing with a national positive reference or a standardized positive reference should be positive.
4.3 Negative reference product compliance rate
Tests with a national negative reference or a standardized negative reference should be negative.
4.4 Minimum detection limit
Use the national minimum detection limit reference or the standard minimum detection limit reference, the result should be no more than 1000ng/mL.
4.5 Repeatability
Tests with national repetitive reference or standardized repetitive reference products should be positive.
4.6 Stability
The following methods can be used for verification.
a) Stability of validity
The kit is stored under the specified conditions until the end of the validity period, and the physical properties, positive reference product compliance rate, negative reference product compliance rate, and most
Low detection limits, repeatability, results should meet the requirements of 4.1, 4.2, 4.3, 4.4 and 4.5.
b) Thermal stability test
Place the kit under the specified conditions (usually 37 ° C) for a specified period of time (usually 21d), check the physical properties, positive reference
Combination rate, negative reference product compliance rate, minimum detection limit, repeatability, the results should meet the requirements of 4.1, 4.2, 4.3, 4.4 and 4.5.
Note 1. Thermal stability cannot be used to derive the expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.
Note 2. According to the product characteristics, one of the above methods a) or b) can be selected for verification, but the selected method should be able to verify the stability of the product to ensure the validity period.
Product performance meets standard requirements.
5 Test methods
5.1 Physical properties
5.1.1 Appearance
Visual inspection of normal or corrected visual acuity under natural light shall comply with the requirements of 4.1.1.
5.1.2 Strip width
Randomly take a strip of film in the kit and use a measuring ruler. The result should meet the requirements of 4.1.2.
5.1.3 Liquid migration speed
Follow the instructions, add the sample solution from the sample loading area, and move the liquid to the reaction zone to start timing until the liquid reaches the reaction.
When the end of the zone is stopped, the time used is recorded as t. The length of the reaction zone is measured with a vernier caliper. When it is recorded as L, the L/t is calculated as the migration speed.
Degree, the result meets the requirements of 4.1.3.
5.2 Positive reference product compliance rate
Test with a national positive reference or a standardized positive reference, follow the product instructions, and the results should be consistent with 4.2.
Claim.
5.3 Negative reference product compliance rate
Test once with a national negative reference or a standardized negative reference, follow the product instructions, and the results should be consistent with 4.3.
Claim.
5.4 Minimum detection limit
Use the national minimum detection limit reference or the standard minimum detection limit reference once, follow the product manual, and the result
Should meet the requirements of 4.4.
5.5 Repeatability
Take the same batch of reagents and perform 10 repeated tests with national repetitive reference products or standardized repetitive reference products.
The operation of the book shall be in accordance with the requirements of 4.5.
5.6 Stability
The following methods can be used for verification.
a) Stability of validity
The kit is stored under the specified conditions until the end of the validity period, and the physical properties, positive reference product compliance rate, negative reference product compliance rate, and most
Low detection limit and repeatability, the results should meet the requirements of 4.6a).
b) Thermal stability test
Place the kit under the specified conditions (usually 37 ° C) for a specified period of time (usually 21d), check the physical properties, positive reference
Combination rate, negative reference product compliance rate, minimum detection limit, repeatability, the results should meet the requirements of 4.6b).
Note 1. Thermal stability cannot be used to derive the expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.
Note 2. According to the product characteristics, one of the above methods a) or b) can be selected for verification, but the selected method should be able to verify the stability of the product to ensure the validity period.
Product performance meets standard requirements.
6 logo, label, instruction manual
Should meet the requirements of GB/T 29791.2-2013.
7 Packaging, transportation and storage
7.1 Packaging
The packaging and transportation pictorial signs shall comply with the requirements of GB/T 191. The packaging container should ensure good sealing, completeness, no leakage, no damage.
7.2 Transportation
The kit should be shipped as required by the manufacturer. During transportation, it should be protected from moisture, and heavy objects should be prevented from being piled up, avoiding direct sunlight and rain and snow.
Dip to prevent contact with acid and alkali substances and prevent damage to the inner and outer packaging.
7.3 Storage
The kit should be stored under the conditions specified by the manufacturer.
references
[1] GB/T 1.1-2009 Standardization work guide Part 1. Standard structure and preparation
[2] National Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (3) [M]. Beijing. China Medical Science and Technology Press,.2010.
[3] Biological Products Regulations (2000 Edition),.2002 Supplement.
[4] Department of Health, Ministry of Health, People's Republic of China. National Clinical Laboratory Practices (3rd Edition) [M]. Nanjing. Southeast University Publishing
Society,.2006.
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