JJF 1874-2020Calibration Specification for (Automatic) Nucleic Acid Extractors (English PDF)

1 Scope (1)

2 Reference documents (1)

3 Overview (1)

4 Measurement characteristics (1)

4.1 Temperature indication error (1)

4.2 Temperature uniformity (1)

4.3 Temperature stability (1)

4.4 Vibration frequency indication error (1)

4.5 Vibration frequency stability (1)

4.6 Indication error of liquid withdrawal (1)

4.7 Repeatability of liquid withdrawal (1)

4.8 Consistency of liquid withdrawal (1)

4.9 Consistency of nucleic acid extraction recovery rate (1)

4.10 Repeatability of nucleic acid extraction recovery rate (1)

4.11 Recovery rate of nucleic acid extraction (1)

5 Calibration conditions (1)

5.1 Environmental conditions (1)

5.2 Calibration equipment and reference materials (2)

6 Calibration items and calibration methods (2)

6.1 Temperature indication error (2)

6.2 Temperature uniformity (2)

6.3 Temperature stability (3)

6.4 Vibration frequency indication error (3)

6.5 Stability of vibration frequency (3)

6.6 Indication error of liquid withdrawal (4)

6.7 Repeatability of liquid withdrawal (4)

6.8 Consistency of the amount of liquid taken (4)

6.9 Consistency of nucleic acid extraction recovery rate (5)

6.10 Repeatability of nucleic acid extraction recovery rate (5)

6.11 Recovery rate of nucleic acid extraction (6)

7 Expression of calibration results (6)

8 Recalibration interval (6)

Appendix A Calibration Raw Record Format (Reference) (7)

Appendix B Format of Calibration Certificate (Inner Page) (10)

Appendix C Example of Uncertainty Evaluation for Calibration Results of Temperature Indication Error (12)

Appendix D Examples of Uncertainty Evaluation of Vibration Indication Error Calibration Results (14)

Appendix E Example of Uncertainty Evaluation of Calibration Results for Indication Error of Liquid Amount (16)

Appendix F Example of Uncertainty Evaluation for Calibration Results of Nucleic Acid Extraction Recovery Rate (18)

Appendix G Pure Water Density Table (20)

Introduction

JJF 1071-2010 "Rules for the Compilation of National Metrology and Calibration Specifications", JJF 1001-2011 "General Metrology Terms and Definition" and JJF 1059.1-2012 "Evaluation and Expression of Measurement Uncertainty" together constitute the support for the revision of calibration specifications the basic series of specifications for work: This specification is based on the experimental test results of the main technical parameters of the (automatic) nucleic acid extractor Based on the preparation, refer to JJF 1527-2015 "Polymerase Chain Reaction Analyzer Calibration Specification":

This specification is released for the first time:

(Automatic) Calibration Specification for Nucleic Acid Extractor

1 Scope

This specification applies to the calibration of automatic nucleic acid extractor and semi-automatic nucleic acid extractor:

2 Reference documents this specification refers to the following documents:

JJF 1059.1-2012 Measurement Uncertainty Evaluation and Expression JJF 1101-2019 Environmental test equipment temperature and humidity calibration specification JJF 1527-2015 Polymerase Chain Reaction Analyzer Calibration Specification for dated reference documents, only the dated version applies to this specification; for undated references the latest version (including all amendments) is applicable to this specification:

3 overview

(Automatic) Nucleic Acid Extractor (hereinafter referred to as the Extractor) is the application of nucleic acid extraction reagents to complete the sample nucleic acid extraction A type of nucleic acid extraction and purification equipment, the principle of which is to lyse and extract samples under certain temperature, vibration and other conditions and purification: The extractor is composed of a temperature control system, an oscillation system, a liquid extraction system and a separation and purification system in whole or in part:

4 Measurement characteristics

4.1 Temperature indication error

4.2 Temperature uniformity

4.3 Temperature stability

4.4 Vibration frequency indication error

4.5 Vibration frequency stability

4.6 Indication error of liquid withdrawal

4.7 Repeatability of liquid withdrawal

4.8 Consistency of liquid withdrawal

4.9 Consistency of nucleic acid extraction recovery rate

4.10 Repeatability of nucleic acid extraction recovery rate

4.11 Recovery rate of nucleic acid extraction

5 Calibration conditions

5.1 Environmental conditions

5.1.1 Ambient temperature: (10~30)°C:

5.1.2 Relative humidity: <=80%:

5.1.3 The room where the extractor is located shall not have obvious mechanical vibration or electromagnetic interference: