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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. JJF 2055-2023: Calibration Specification for Digital Polymerase Chain Reaction Analyzers Status: Valid
Basic dataStandard ID: JJF 2055-2023 (JJF2055-2023)Description (Translated English): Calibration Specification for Digital Polymerase Chain Reaction Analyzers Sector / Industry: Metrology & Measurement Industry Standard Word Count Estimation: 26,286 Date of Issue: 2023-06-30 Date of Implementation: 2023-12-30 Issuing agency(ies): State Administration for Market Regulation JJF 2055-2023: Calibration Specification for Digital Polymerase Chain Reaction Analyzers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.National Metrology Technical Specifications of the People's Republic of China Calibration Specifications for Digital Polymerase Chain Reaction Analyzers Published on 2023-06-30 Implemented on 2023-12-30 Released by the State Administration for Market Regulation Digital polymerase chain reaction analysis Instrument calibration specifications Focal point. National Biometrics Technical Committee Main drafting unit. China Institute of Metrology Unit participating in the drafting. Nanjing Institute of Metrology Supervision and Inspection China Institute of Testing Technology The National Biometrics Technical Committee is entrusted with the interpretation of this specification. The main drafters of this specification. Dong Lianhua (China Institute of Metrology) Wang Jing (China Institute of Metrology) Gao Yunhua (China Institute of Metrology) Participating drafters. Wang Shangjun (Nanjing Metrology Supervision and Inspection Institute) Chen Hongfei (Nanjing Metrology Supervision and Inspection Institute) Zhou Lihua (China Institute of Testing Technology) Table of contentsIntroduction(Ⅱ) 1 Scope(1) 2 Cited documents(1) 3 Terminology and units of measurement(1) 3.1 Digital PCR (1) 3.2 Digital PCR instrument(1) 3.3 Number of copies(1) 3.4 Copy number concentration(1) 4 Overview(2) 5 Measuring characteristics(2) 6 Calibration conditions(3) 6.1 Environmental conditions(3) 6.2 Measurement standards and other equipment(3) 7 Calibration items and calibration methods (3) 7.1 Calibration conditions(3) 7.2 Temperature indication error and temperature uniformity calibration (3) 7.3 Heating and cooling rate calibration(5) 7.4 Relative error calibration of copy number concentration indication (6) 7.5 Copy number concentration repeatability calibration (7) 7.6 Fluorescence intensity repeatability(8) 7.7 Repeatability of the number of reaction units (8) 8 Calibration result expression(8) 8.1 Calibration result processing(8) 8.2 Calibration certificate(8) 8.3 Measurement uncertainty of calibration results(9) 9 Recalibration time interval(9) Appendix A Preparation and use of standard materials and fluorescent solutions (10) Appendix B Preparation of reaction system (11) Appendix C Calibration original record reference format (12) Appendix D Calibration Certificate (Inside Pages) Reference Format (14) Appendix E Example of Uncertainty Assessment of Relative Error of Copy Number Concentration Indication (16) Appendix F Example of uncertainty evaluation of temperature indication error calibration results (19)IntroductionJJF 1071 "Rules for Writing National Measurement Calibration Specifications", JJF 1001 "General Measurement Terms and Definitions" and JJF 1059.1 "Evaluation and Expression of Measurement Uncertainty" together constitute the basic series supporting the formulation of this specification. specification. Calibration methods and measurement characteristics mainly refer to JJF 1527 "Polymerase Chain Reaction Analyzer Calibration Specifications", YY/T 1173 "Polymerase Chain Reaction Analyzer" and ISO 20395.2019 "Biotechnology - Nucleic acid target sequence determination" dPCR). This specification is released for the first time. Calibration Specifications for Digital Polymerase Chain Reaction Analyzers1 ScopeCalibration of measurement performance can be performed with reference to this specification for other types of digital PCR instruments.2 cited documentsThis specification references the following documents. JJF 1527 Polymerase Chain Reaction Analyzer Calibration Specification YY/T 1173 Polymerase Chain Reaction Analyzer ISO 20395.2019 Biotechnology - Requirements for performance evaluation of methods for quantification of nucleic acid target sequences - qPCR methods and For dated references, only the dated version applies to this specification; for undated references, only the dated edition applies. The latest version (including all modification orders) shall apply to this specification.3 Terminology and units of measurement3.1 Digital PCR digitalPCR, dPCR Distribute the nucleic acid template into multiple reaction units of equal volume, each reaction unit may or may not contain one or more copy of the target sequence (nucleic acid template), perform PCR amplification of the target sequence, and detect the specific PCR product After testing, the concentration or copy number of the target sequence is calculated based on the proportion of positive droplets and the principle of Poisson distribution. Note 1.It is assumed that during the segmentation process, the nucleic acid target sequences are randomly and independently distributed in each reaction unit. Note 2.The counting of positive and negative segments is usually done in the end-point detection of PCR products after the thermal cycle reaction, and there are also some The dPCR platform can perform real-time qPCR monitoring of PCR products. [ISO 20395.2019,3.10] 3.2 Digital PCR analyzer digitalPCRanalyzer Based on the principle of PCR technology, it simulates the DNA or RNA replication process, in nucleic acid templates, primers, polymerase, etc. Under the conditions that exist, the nucleic acid template is distributed in multiple reaction units to specifically amplify the known sequence, and the amplified fluorescence Instruments and equipment for detecting and analyzing optical signals. 3.3 copiesnumber copiesnumber The number of molecules containing a specific nucleic acid sequence. [ISO 20395.2019,3.6] The number of molecules containing a specific nucleic acid sequence per unit volume. Note. The unit of measurement is copies/μL. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of JJF 2055-2023_English be delivered?Answer: Upon your order, we will start to translate JJF 2055-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of JJF 2055-2023_English with my colleagues?Answer: Yes. The purchased PDF of JJF 2055-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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