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JJF 2057-2023 English PDF

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JJF 2057-2023: Calibration Specification for C-reactive Protein Analyzers
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JJF 2057-2023English339 Add to Cart 4 days [Need to translate] Calibration Specification for C-reactive Protein Analyzers Valid JJF 2057-2023

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Basic data

Standard ID JJF 2057-2023 (JJF2057-2023)
Description (Translated English) Calibration Specification for C-reactive Protein Analyzers
Sector / Industry Metrology & Measurement Industry Standard
Word Count Estimation 16,111
Date of Issue 2023-06-30
Date of Implementation 2023-12-30
Issuing agency(ies) State Administration for Market Regulation

JJF 2057-2023: Calibration Specification for C-reactive Protein 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 C-reactive protein analyzer calibration specifications Published on 2023-06-30 Implemented on 2023-12-30 Released by the State Administration for Market Regulation C-reactive protein analyzer calibration specifications Focal point. National Biometrics Technical Committee Drafting unit. Nanjing Metrology Supervision and Inspection Institute China Institute of Metrology The National Biometrics Technical Committee is entrusted with the interpretation of this specification. Drafter of this specification. Hu Ning (Nanjing Metrology Supervision and Inspection Institute) Song Dewei (China Institute of Metrology) Xu Sheng (Nanjing Metrology Supervision and Inspection Institute) Wu Liqing (China Institute of Metrology) Chen Hongfei (Nanjing Metrology Supervision and Inspection Institute)

Table of contents

Introduction(Ⅱ) 1 Scope(1) 2 Cited documents(1) 3 Terminology and units of measurement(1) 4 Overview(1) 5 Metrology characteristics(1) 6 Calibration conditions(2) 6.1 Environmental conditions(2) 6.2 Standard materials and other equipment for calibration (2) 7 Calibration items and calibration methods (2) 7.1 Preparation and inspection before calibration (2) 7.2 Measurement indication error (2) 7.3 Measurement repeatability(2) 7.4 Measuring linear dependence(3) 8 Calibration result expression(3) 8.1 Calibration result processing(3) 8.2 Calibration certificate(3) 8.3 Measurement uncertainty of calibration results(3) 9 Recalibration time interval (4) Appendix A Contents of Calibration Records and Calibration Certificates (5) Appendix BC Reactive Protein Analyzer Indication Error Measurement Uncertainty Evaluation (8) Appendix C Preparation method of linear correlation calibration solution (10)

Introduction

JJF 1071-2010 "Rules for Writing National Measurement Calibration Specifications", JJF 1001-2011 "General Measurement Terminology and Definition" and JJF 1059.1-2012 "Evaluation and Expression of Measurement Uncertainty" jointly support the formulation of this specification basic series of specifications. The formulation of this specification mainly refers to GB/T 26124-2011 "Clinical Chemistry In Vitro Diagnostic Reagents (Kit)", CLSIEP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures. Statistical Methods; Approval Guide" (Evaluation of the Guideline) and current technical documents related to C-reactive protein analyzers. This specification is released for the first time. C-reactive protein analyzer calibration specifications

1 Scope

This specification is applicable to the measurement of C-reactive protein test items in C-reactive protein analyzers and specific protein analyzers. Calibration of performance.

2 cited documents

This specification references the following documents. JJF 1001-2011 General measurement terms and definitions JJF 1265-2022 Biometric terms and definitions GB/T 26124-2011 Clinical chemistry in vitro diagnostic reagents (box) 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 measurement

The following terms and definitions defined in JJF 1001-2011 and JJF 1265-2022 apply to this specification. 3.1 C-reactive protein, CRP Some proteins (acute proteins) that rise sharply in the plasma when the body is infected or tissue damaged. The protein It contains 224 amino acids and has a relative molecular mass of 25106.It is composed of 5 unglycosylated polypeptide subunits with the same structure. Connected.

4 Overview

The C-reactive protein analyzer is a biometric instrument used to measure the concentration of C-reactive protein in human blood. The measurement methods of C-reactive protein in the C-reactive protein analyzer mainly include immunoturbidimetry, immunofluorescence, and gold standard Law etc. The immunoturbidimetric method uses C-reactive protein specific antibodies to bind to C-reactive protein in human blood to form an antigen. For antibody complexes, the concentration of C-reactive protein can be obtained by detecting its scattered light or transmitted light intensity; immunofluorescence method is The fluorescently labeled anti-C-reactive protein antibody is used to combine with the C-reactive protein antigen in the blood to form an antigen-antibody complex. The complex is captured by the anti-C-reactive protein antibody fixed on the detection plate, and C-reactive protein is obtained by detecting the fluorescence intensity. The concentration of reactive protein; the gold labeling method uses C-reactive protein to bind to specific monoclonal antibodies fixed on the membrane. form a complex, and then the complex is combined with the added colloidal gold antibody conjugate, and the luminescence intensity of the colloidal gold is detected. Obtain the concentration of C-reactive protein. The C-reactive protein analyzer mainly consists of a sampling system, a detection system, a display system and supporting reagents and calibrators. composition.

5 Metering characteristics

The main measurement performance indicators of the C-reactive protein analyzer are shown in Table 1.

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