YY/T 1656-2020Detection kit for morphine(colloidal gold method) (English PDF)

4.1 Physical properties

4.1.1 Appearance

It should be smooth in appearance, firmly attached to materials, complete in content, clean in appearance, no leakage, and no damage.

4.1.2 Film strip width

The width of the film strip should not be less than 2.5mm.

4.1.3 Liquid moving speed

The liquid moving speed should not be less than 20mm/min.

4.2 Compliance rate of positive reference products

Use national positive reference materials or standardized positive reference materials for testing, and the results should be positive.

4.3 Compliance rate of negative reference products

Use national negative reference material or standardized negative reference material for testing, the result should be negative.

4.4 Minimum detection limit

Use national minimum detection limit reference material or standardized minimum detection limit reference material for detection, should not be higher than 300ng/mL.

4.5 Repeatability

Use national repetitive reference products or standardized repetitive reference products for testing, and the results should all be positive.

4.6 Stability

The validity period stability and thermal stability should be selected according to the product characteristics for verification.

a) Stability of validity period The kit is stored under the specified conditions until the end of the validity period, and the physical properties, the compliance rate of positive reference products, and the compliance of negative reference products are tested Rate, minimum detection limit, repeatability, and the results should meet the requirements of 4.1, 4.2, 4.3, 4.4 and 4.5.

b) Thermal stability test Place the kit at 37°C for 21 days to check the physical properties, positive reference product compliance rate, negative reference product compliance rate, and minimum detection Limit and 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 expiry date of the product, unless it is a derivation formula based on a large amount of stability research data.

Note 2.Choosing 4.6a) or 4.6b) should be able to verify the stability of the product.

Note 3.Generally, when the validity period is 2 years, choose the product not exceeding 2 months, when the validity period is 1 year, choose the product not exceeding 1 month, and so on. But Ruchao After the specified time, the product is acceptable if it meets the requirements.

5.1 Physical properties

5.1.1 Appearance

Visual inspection with normal vision or corrected vision under natural light should meet the requirements of 4.1.1.

5.1.2 Film strip width

Take 1 film strip from the kit at random and use a measuring ruler to test. The result should meet the requirements of 4.1.2.

5.1.3 Liquid moving speed

Operate according to the instructions, add sample liquid from the sample area of the kit, move the liquid to the reaction area and start timing until the liquid reaches the reaction Stop timing at the end of the zone, record the time used as (t), use a vernier caliper to measure the length of the reaction zone, record it as (L), then calculate L/t as shift Travel speed, the result meets the requirements of 4.1.3.

5.2 Compliance rate of positive reference products

Use the national positive reference product or the standardized positive reference product to test once, and operate according to the product manual. The result should meet 4.2 Claim.

5.3 Compliance rate of negative reference products

Use a national negative reference product or a standardized negative reference product to test once, and operate according to the product manual. The result should meet 4.3 Claim.

5.4 Minimum detection limit

Use the national minimum detection limit reference product or the standardized minimum detection limit reference product to test once, and operate according to the product manual, the result Should meet the requirements of 4.4.

5.5 Repeatability

Take the same batch of reagents, use national repetitive reference products or standardized repetitive reference products for 10 repeated tests, according to the product description The operation is carried out in the specified document, and the result should meet the requirements of 4.5.

5.6 Stability

5.6.1 Stability of validity period

The kit is stored under the specified conditions until the end of the validity period, and the physical properties, the compliance rate of positive reference products, the compliance rate of negative reference products, and the most Low detection limit, repeatability, and the results should meet the requirements of 4.6a).

5.6.2 Thermal stability test

Place the kit at 37°C for 21 days to check the physical properties, the compliance rate of positive reference products, the compliance rate of negative reference products, the minimum detection limit, and the weight Refolding, the result should meet the requirements of 4.6b).

7.1 Packaging

The packaging, storage and transportation pictorial signs should meet the requirements of GB/T 191. The packaging container should ensure good sealing, completeness, no leakage, and no damage.

7.2 Transportation

The kit should be transported as required by the manufacturer. During transportation, it should be moisture-proof, heavy objects should be prevented from being piled up, and direct sunlight, rain and snow should be avoided 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.

A.1 Purpose

Used for quality control and evaluation of morphine detection kit (colloidal gold method).

A.2 Specifications

This reference product consists of 23 samples.

A.2.1 Positive reference

3 positive reference products, numbered P1~P3, containing 300ng/mL codeine, 300ng/mL heroin, 300ng/mL Sample of O6-monoacetylmorphine.

A.2.2 Negative reference material

16 negative reference products, numbered N1~N16; the variety and concentration of negative reference products are shown in Table A.1.

A.2.3 Reference material for the lowest detection limit

3 reference products with minimum detection limit, numbered L1~L3, containing 300ng/mL, 150ng/mL, 75ng/mL morphine respectively sample.

A.2.4 Repeatable reference products

One reproducible reference product, numbered R, is a sample containing 300ng/mL morphine.

A.3 Usage and precautions

Shake well and use directly after placing at room temperature. Please use it according to the instructions. If it is used for other purposes, the user needs to prove its applicability.

The current reference product instructions can be found on the website of China Food and Drug Control Institute. The reference product instructions will be imported according to the batch of reference products.

Line changes. references [1] National Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. Three [M]. Beijing. China Medical Science and Technology Press, 2015.

[2] China Biological Products Standardization Committee. Biological Products Regulations (2000 Edition) [M]. Beijing. Chemical Industry Press.

[3] Medical Administration Department of the Ministry of Health of the People's Republic of China. National Clinical Laboratory Practice [M]. 4th edition. Nanjing. Southeast University Press, 2000.

[4] National Reference Manual for Morphine Test Kit (Colloidal Gold Method)