YY/T 1656-2020 in English

VALID

Detection kit for morphine(colloidal gold method)

Issued on:2020-02-25
Implemented on:2021-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	YY/T 1656-2020
Document status:	VALID
Title in English:	Detection kit for morphine(colloidal gold method)
Title in Chinese:	吗啡检测试剂盒（胶体金法）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-02-25
Implemented on:	2021-03-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
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本标准规定了吗啡检测试剂盒（胶体金法）标准的术语和定义、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等。
本标准适用于通过胶体金免疫层析法原理，定性检测人体尿液中吗啡（morphine，MOP）的检测试剂盒及包含吗啡的联合检测试剂盒。
本标准不适用于进行非人尿液检测的吗啡检测试剂盒。

Introduction

Standard Overview and Technical Background

This standard specifies the technical requirements, test methods, labeling and storage conditions of the Morphine Detection Kit (Colloidal Gold Method). As a representative substance of opioid drugs, the rapid detection of morphine (MOP) has important application value in forensic identification, drug control and medical supervision.

Key Technical Indicators

Project	Requirement	Test Method
Detection Limit	≤300ng/mL	Immunochromatography
Precision	CV≤20%	Repeatability Test
Stability	Stored at 37℃ for 21 days	Accelerated Stability Test

Details of Performance Requirements

4.1 Physical indicators

Kit components include: test card, diluent, instructions, etc. The width of the test card reaction membrane should be ≥2.5mm, and the liquid migration speed should be controlled at 20mm/min±5mm.

4.2 Negative reference conformity rate

When using 16 negative samples for testing, the results should meet the negative judgment standard, with a specificity of ≥95%. The standard specifically stipulates the cross-reaction requirements of common interfering substances (such as codeine and papaverine).

Implementation recommendations

Key points for production process control

Colloidal gold particle size should be controlled in the range of 20-40nm
Antibody labeling efficiency should be verified by UV spectrophotometry
Chromatographic membranes should be tested for batch consistency

Quality evaluation methods

Western blot is recommended to verify antibody specificity, and atomic force microscopy (AFM) is used to detect the morphology of the gold-labeled antibody complex to ensure that the detection limit requirements specified in Article 4.4 are met.

Technology Evolution Analysis

Compared with GB/T 29791.2-2013 series standards, this document proposes special requirements for Morphine Colloidal Gold Detection for the first time:

Add high temperature accelerated stability index (37℃21 days)
Clear stability requirements for reconstitution of freeze-dried products
Specify the color uniformity judgment standard of the test line/quality control line

More samples: JJG 21-2008 QC/T 942-2021 GB 50021-2001(2009)

Sample only — not a preview of YY/T 1656-2020

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