GB/T 42080.1-2022 in English

VALID

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1: Isolated RNA

Issued on:2022-12-30
Implemented on:2023-07-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $210.00
$204.00

Standard No:	GB/T 42080.1-2022
Document status:	VALID
Title in English:	Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1: Isolated RNA
Title in Chinese:	分子体外诊断检验冷冻组织检验前过程的规范第1部分：分离RNA
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2022-12-30
Implemented on:	2023-07-01
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	frozen tissues rna isolation rna isolation rna isolation method vitro diagnostic examinations specifications rna introduction
Related Topics:	molecular rna stranded RNA molecular diagnosis Precursor ion front of rna laboratory freezing time rna precursor ion window Outsourcing Equipment Inspection Regulations detect rna gold Tissue Separator Cadmium ion test Analytical Testing In Vitro Diagnostic frozen vial in rna Precursor ion frozen vial diagnostic molecule molecular english Molecular Diagnostic Tests Molecular Diagnosis English molecular diagnosis freeze separation laboratory freezing molecular organization molecular test strand rna Testing of tantalum ions molecular test Single-stranded RNA detection In vitro/be frozen tissue precursor ion mode Cadmium ion test diagnostic ion Precursor ion rna ultraviolet detection Molecular diagnostic cutting-edge technology Tissue primary isolation molecular version UV detection of RNA method of rna detection Testing of silver ions RNA extraction after tissue freezing

《GB/T 42080.1-2022分子体外诊断检验冷冻组织检验前过程的规范第1部分：分离RNA》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药监局。

Introduction

1. Standard background and technological evolution

GB/T42080.1-2022 "Specification for pre-testing procedures of frozen tissues for molecular in vitro diagnostic testing Part 1: Isolation of RNA" is equivalent to ISO201841:2018, which aims to standardize the pre-testing operation steps of RNA in frozen tissues. This standard fills the gap in the standardization of RNA processing procedures in the field of molecular diagnosis, and is particularly suitable for medical laboratories and molecular pathology laboratories.

2. Comparison of standard frameworks

Dimensions	GB/T42080.1-2022	ISO201841:2018	Difference analysis
Scope	Pre-test process for RNA isolation from frozen tissues	RNA isolation in molecular in vitro diagnostics	Equivalent adoption, no substantial changes
Core requirements	Standardize specimen collection, transportation, freezing and RNA extraction processes	Emphasis on quality control of RNA isolation	Add stability study under cold ischemia conditions
Applicable scenarios	Medical laboratories, molecular pathology laboratories	Clinical diagnosis and biomedical research	Expanded specimen handling requirements outside the laboratory

3. Implementation recommendations

Case study:After adopting this standard, a tertiary hospital significantly improved the quality and efficiency of RNA isolation. The following are the specific implementation steps:

Specimen collection:Ensure that patient information, surgical details, and environmental conditions are recorded during the collection process.
Freezing:Use isopentane or liquid nitrogen for rapid freezing to reduce the risk of RNA degradation.
Quality control:Regularly verify the accuracy and stability of the RNA isolation method to ensure that it meets diagnostic requirements.

More samples: GB 18306-2015 GB 50021-2001(2009) YD/T 3934-2021

Sample only — not a preview of GB/T 42080.1-2022

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