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JJF 1838-2020 English PDF

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JJF 1838-2020: (Calibration specification for genetic analyzer)
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Basic data

Standard ID JJF 1838-2020 (JJF1838-2020)
Description (Translated English) (Calibration specification for genetic analyzer)
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 14,199
Date of Issue 2020-07-02
Date of Implementation 2021-01-02
Regulation (derived from) Announcement No. 29 (2020) of the State Administration for Market Regulation
Issuing agency(ies) State Administration for Market Regulation

JJF 1838-2020: (Calibration specification for genetic analyzer)

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(Calibration specification for genetic analyzer) National Metrology Technical Specification of the People's Republic of China Genetic Analyzer Calibration Specification Published on 2020-07-02 2021-01-02 Implementation Released by the State Administration for Market Regulation Genetic Analyzer Calibration Specification Focal Point. National Biometric Technology Committee Main drafting unit. China Institute of Metrology Ministry of Public Security Physical Evidence Identification Center This specification is entrusted to the National Biometric Technology Committee to be responsible for the interpretation The main drafters of this specification. Gao Yunhua (China Institute of Metrology) Wang Jing (China Institute of Metrology) Zhao Xingchun (Material Evidence Identification Center of the Ministry of Public Security) Liu Bing (Material Evidence Identification Center of the Ministry of Public Security) Wang Le (Material Evidence Identification Center of the Ministry of Public Security)

content

Introduction (Ⅱ) 1 Scope(1) 2 References (1) 3 Overview(1) 4 Metrology Characteristics(1) 5 Calibration Conditions(1) 5.1 Environmental Requirements(1) 5.2 Standard materials and equipment for calibration (2) 6 Calibration items and calibration methods (2) 6.1 Baseline Drift and Baseline Noise(2) 6.2 Qualitative (quantitative) repeatability (2) 6.3 Channel Difference(3) 6.4 Detection limit(3) 7 Expression of calibration results (3) 8 Recalibration interval(4) Appendix A Example of Uncertainty Evaluation of Detection Limit Measurement Results (5) Appendix B Calibration Raw Record Reference Format(7) Appendix C Calibration Certificate (Inner Page) Reference Format (9)

Introduction

This specification is compiled in accordance with the requirements of JJF 1071-2010 "Rules for the Compilation of National Metrology Calibration Specifications". Tested JJG964-2001 "Capillary Electrophoresis Instrument". This specification is published for the first time. Genetic Analyzer Calibration Specification

1 Scope

This specification applies to the calibration of genetic analyzers based on the principle of capillary electrophoresis. Other types of genetic analyzers may be Follow this specification.

2 Reference documents

This specification references the following documents. JJG964-2001 Capillary Electrophoresis Instrument For dated references, only the dated version applies to this specification; for undated references The latest version (including all amendments) applies to this specification.

3 Overview

The genetic analyzer (hereinafter referred to as the instrument) is mainly composed of capillary electrophoresis equipment, computer engineering for control and data analysis. It is composed of software and data analysis software for platform and sample number input, equipment control and data collection. Polymorphism analysis work, including microsatellite DNA analysis, fragment length analysis (STR), comparative genotyping, Single nucleotide polymorphism (SNP) research can also complete the determination of gene sequence or comparative sequencing. conduct During DNA fragment analysis, the sample genome was amplified by PCR using different labeled primers and subjected to capillary electroporation. Swimming, the amplified products are distinguished according to the molecular weight (fragment length), through the internal standard of molecular weight and the established etc. Automatic comparison of allelic standards, genotyping results are given in digital form, and STR loci are directly reflected The number of repetitions of the core sequence in the allele. During sequencing analysis, the dideoxynucleotide end termination method was used to The four nucleotides of ATCG of different labeled ddNTPs are collected by the detector. The instrument has a more comprehensive The DNA fragment length analysis and gene sequencing functions can provide users with corresponding analysis data for forensic medicine. DNA analysis, clinical diagnostics and research use.

4 Metrology characteristics

4.1 Baseline drift 4.2 Baseline Noise 4.3 Qualitative (quantitative) repeatability 4.4 Channel Differences 4.5 Detection limit

5 Calibration Conditions

5.1 Environmental conditions The instrument uses the allowable environmental conditions, temperature. (15~35) ℃, relative humidity. (10~80)%. Warm up

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