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JJF 2035-2023 English PDF

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JJF 2035-2023: Calibration Specification for Enzyme-linked Immunospot Analyzers
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JJF 2035-2023English379 Add to Cart 4 days [Need to translate] Calibration Specification for Enzyme-linked Immunospot Analyzers Valid JJF 2035-2023

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Basic data

Standard ID JJF 2035-2023 (JJF2035-2023)
Description (Translated English) Calibration Specification for Enzyme-linked Immunospot Analyzers
Sector / Industry Metrology & Measurement Industry Standard
Word Count Estimation 17,114
Date of Issue 2023-03-15
Date of Implementation 2023-09-15
Issuing agency(ies) State Administration for Market Regulation

JJF 2035-2023: Calibration Specification for Enzyme-linked Immunospot 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 JJF 2035-2023 Calibration specification for dot enzyme immunoassay analyzer Released on 2023-03-15 2023-09-15 Implementation Released by the State Administration for Market Regulation Dot ELISA Calibration specification Responsible Unit: National Biometric Technology Committee Main drafting unit: Shanghai Institute of Metrology and Testing Technology Participating in the drafting unit: China Institute of Metrology This specification entrusts the National Biometric Technology Committee to be responsible for interpretation The main drafters of this specification: Li Lanying (Shanghai Institute of Metrology and Testing Technology) Wang Lele (Shanghai Institute of Metrology and Testing Technology) Liu Gang (Shanghai Institute of Metrology and Testing Technology) Participating drafters: Mi Wei (National Institute of Metrology) Wu Liqing (National Institute of Metrology)

Table of contents

Introduction (Ⅱ) 1 Scope(1) 2 References(1) 3 terms(1) 4 Overview(1) 5 Metrological characteristics(1) 6 Calibration conditions(1) 6:1 Environmental conditions (1) 6:2 Reference materials (2) 7 Calibration Items and Calibration Methods(2) 7:1 Indication error of spot count (2) 7:2 Repeatability(2) 8 Calibration result expression(2) 9 Recalibration interval(3) Appendix A Schematic Diagram of Simulated Spot Counting Standard Substances and Screens in Wells (4) Appendix B Calibration Original Record Reference Format (6) Appendix C Recommended Format for the Inside Page of the Calibration Certificate (7) Appendix D Example of Uncertainty Assessment of Measurement Results of Indication Error of Spot Counting (9)

Introduction

JJF 1071-2010 "Rules for Compilation of National Metrology Calibration Standards", JJF 1001-2011 "General Metrology Terminology and "Definition" and JJF 1059:1-2012 "Assessment and Expression of Measurement Uncertainty" jointly constitute the support for the formulation of this specification The basic series of specifications: This specification is published for the first time: Calibration specification for dot enzyme immunoassay analyzer

1 Scope

This specification is applicable to the calibration of the dot enzyme-linked immunosorbent analyzer, and the calibration of other plate types (48-well plate or 24-well plate, etc:) The spot enzyme-linked immunosorbent analyzer can be calibrated according to this specification:

2 References

This specification references the following documents: ANSI/SLAS4-2004 Microwell reaction plate: Well position (Microplates-WelPositions) For dated references, only the dated version applies to this specification; for undated references document, its latest version (including all amendments) applies to this specification:

3 terms

By coating antibodies on special microwell reaction plates, cells secreting specific cytokines are captured, and then enzyme-linked technology It is an analytical instrument that automatically microscopically counts the colored spots to form tiny spots corresponding to the cells:

4 Overview

The dot enzyme-linked immunosorbent analyzer (hereinafter referred to as the analyzer) is mainly composed of an imaging system, a motion system, and a control processing system: system and display system: During the analysis, the imaging system acquires the spot images in the wells on the microwell reaction plate, and then displays the The system performs spot statistics to obtain the total number of spots in the hole:

5 Metrological characteristics

The metering characteristics and metering characteristic indicators of the analyzer are shown in Table 1: Table 1 Quantitative characteristics of dot enzyme-linked immunosorbent analyzer Measuring characteristics Measuring characteristic indicators Spot count indication error ±5:0% Repeatability≤2:0% Note: The above technical indicators are not applicable to qualification judgment and are for reference only:

6 Calibration conditions

6:1 Environmental conditions 6:1:1 Temperature: (15~30)℃;

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