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GB/T 42080.2-2022Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

July 1, 2023

Scope

GB/T 42080.2-2022 (Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins) is available as an English-translated PDF.

GB/T 42080.2-2022 is the Chinese standard "Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins".

Its scope clause reads: This document provides guidelines for the handling, documentation, storage of frozen tissue specimens for protein testing in the pre-test phase prior to molecular analysis.

A guide to archiving and retrieving materials. This document is applicable to any molecular in vitro diagnostics performed by medical laboratories and molecular pathology laboratories on proteins extracted from frozen tissues test.

This document is also applicable to laboratory customers, developers and manufacturers of in vitro diagnostics, biobanks, institutions conducting biomedical research and business organizations and regulators.

Note. International, national or regional regulations or requirements can also apply to specific content covered by this document. Its clauses include terms and definitions.

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Document preview — GB/T 42080.2-2022

National Standard of the People's Republic of China

ICS: 11.100.10
Classification: C 30

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 General
5 Lab Exterior
5.1 Specimen collection
5.2 Fresh tissue shipping requirements
6 Inside the laboratory
6.1 Specimen Receiving Information
6.2 Specimen pathological evaluation and sample selection
6.3 Freezing of Specimens or Samples
6.4 Storage requirements
6.5 Separation of total protein
6.6 Qualitative and quantitative evaluation of isolated proteins
6.7 Storage of isolated proteins
Appendix A (informative) Quantitative detection of protein shows the change of protein content during cold ischemia

1 Scope

This document provides guidelines for the handling, documentation, storage of frozen tissue specimens for protein testing in the pre-test phase prior to molecular analysis.

A guide to archiving and retrieving materials.

This document is applicable to any molecular in vitro diagnostics performed by medical laboratories and molecular pathology laboratories on proteins extracted from frozen tissues test. This document is also applicable to laboratory customers, developers and manufacturers of in vitro diagnostics, biobanks, institutions conducting biomedical research and business organizations and regulators.

Note. International, national or regional regulations or requirements can also apply to specific content covered by this document.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements (ISO 15189.2012,

IDT)

3 Terms and Definitions

The following terms and definitions defined in GB/T 22576.1-2018 apply to this document.

The ISO and IEC terminology databases for standardization are maintained at the following addresses.

3.1 aliquot of sample

Assuming that sampling errors are negligible, a portion of a mass of homogeneous substance.

Note 1.This term is usually applied to liquids. Tissues are heterogeneous and so cannot be equally divided.

Note 2.This term is derived from references [17], [18], [19].

3.2 Ambient temperature

The temperature of the unconditioned ambient air.

3.3 Analyte

The component represented by the name of the measurand.

[Source. GB/T 21415-2008, 3.2]

3.4

Measures the accuracy, precision, and sensitivity of an assay for the analyte being measured.

Note. It can also be applied to other detection performance characteristics, such as robustness, repeatability, etc. […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 22576.1-2018Medical laboratories - Requirements for quality and competence - Part 1: General requirements

ISO 15189.2012

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