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JJF 1527-2015 English PDF

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JJF 1527-2015: Calibration specification for polymerase chain reaction analyzers
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Basic data

Standard ID JJF 1527-2015 (JJF1527-2015)
Description (Translated English) Calibration specification for polymerase chain reaction analyzers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A61
Classification of International Standard 17.020
Word Count Estimation 20,298
Date of Issue 2015-06-15
Date of Implementation 2015-09-15
Quoted Standard GB/T 6682-2008; YY/T 1173-2010
Regulation (derived from) AQSIQ Announcement 2015 No.72
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine
Summary This Standard applies to heating module polymerase chain reaction (PCR) measurement of performance analyzer calibration for other types of PCR, may refer to this standard.

JJF 1527-2015: Calibration specification for polymerase chain reaction analyzers

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Calibration specification for polymerase chain reaction analyzers People's Republic of China National Metrology Technical Specifications Polymerase chain reaction analyzer calibration specification Issued on. 2015-06-15 2015-09-15 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Polymerase chain reaction analyzer calibration specification zers NFP. National Technical Committee biometric The main drafting units. China Institute of Metrology Participated in the drafting unit. Shanghai Institute of Measurement and Testing Guangdong Provincial Institute of Metrology Tianjin Institute of Supervision and Testing Weighing This specification entrusted to the National Technical Committee is responsible for interpreting biometric The main drafters of this specification. GAO Yun Hua (China Institute of Metrology) Drafters participate. Zhang Liping (Shanghai Institute of Measurement and Testing) Yin Qiang (Guangdong Institute of Metrology) Tian Yun (Tianjin Supervision and Testing Institute of Metrology) Paul Zhijuan (Guangdong Institute of Metrology) Wu Jianying (Shanghai Institute of Measurement and Testing)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 Terms (1) 3.1 Polymerase chain reaction (1) 3.2 Polymerase chain reaction analyzer (1) 4 Overview (1) 5 Metrological characteristics (1) Calibration Condition 6 (2) 6.1 Calibration equipment and reference material (2) 7 calibration items and calibration methods (2) 7.1 Calibration Condition (2) 7.2 Temperature indication error, temperature uniformity calibration (2) 7.3 l cooling rate calibration (4) 7.4 Quantitative PCR instrument indication error sample, sample linear calibration (5) 8 calibration results expression (6) 9 Recalibration interval (6) Appendix A standard preparation and the preparation of material (7) Appendix B PCR reaction system preparation (9) Appendix C shows the temperature calibration error of Uncertainty evaluation model (10) Appendix D shows a sample error of Uncertainty evaluation model (12) Appendix E calibration reference the original record format (14) F calibration certificate (within the page) reference format (15) Appendix

Introduction

The preparation of the specification based on the polymerase chain reaction analyzer main technical parameters of experimental tests, reference is made JJF 1030- 2010 "bath calibration specification", SN/T 2102.1-2008/ISO 22174.2005 "Foodborne pathogens PCR Detection Technical specifications - Part 1. General requirements and definitions ", SN/T 2102.2-2008/ISO 20836.2005 "Foodborne pathogens PCR detection technology specification Part 2. PCR performance test requirements", YY/T 1173- 2010 "polymerase chain reaction analyzer" and other documents. This specification is the first release. Polymerase chain reaction analyzer calibration specification

1 Scope

This instruction applies to polymerase chain reaction module heating (PCR) analyzer calibration measurement of performance, other Types of PCR, can refer to these specifications. 2. References This specification refers to the following documents. GB/T 6682-2008 national standard analytical laboratory use YY/T 1173-2010 polymerase chain reaction analyzer For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.

3 Terms

3.1 Polymerase chain reaction polymerasechainreaction, PCR [YY/T 1173-20103.1] Kind of specific DNA or RNA fragments in vitro method of rapid amplification by denaturation - Annealing - extension Stretched three basic reaction steps constitute. 3.2 Polymerase chain reaction analyzer polymerasechainreactionanalyzer [YY/T 1173-20103.2] Based on PCR (polymerase chain reaction) technology principle, the analog of DNA or RNA replication, the template, Under a primer, polymerase and other conditions of existence, specific amplification of known sequences, its detection and analysis of equipment.

4 Overview

Polymerase chain reaction analyzer is based on replication PCR technology principle, simulate DNA or RNA, in the mold The lower plate, primers, polymerase and other conditions of existence, known sequence specific amplification, detection and analysis of its instruments provided Equipment, including qualitative and quantitative PCR instrument PCR instrument categories. Qualitative PCR usually consists of a sample stage, thermal cycling components, Control and power components with parts and other components. Quantitative PCR instrument consists of a sample stage, thermal cycling part, the control unit Constituent elements, optical detection means, power components, computer and application software components.

5 Metrological characteristics

Metrological characteristics are shown in Table 1. Table 1 polymerase chain reaction analyzer metrological characteristics Project stereotypes PCR quantitative PCR instrument Temperature indication error Temperature uniformity The average heating rate

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