GB/T 33260.5-2018Capability of detection -- Part 5: Methodology in the linear and nonlinear calibration cases (English PDF)
检出能力 第5部分:非线性校准情形检出限的确定方法
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
June 7, 2018
Implementation date
January 1, 2019
Scope
GB/T 33260.5-2018 is the English-translated version of 检出能力 第5部分:非线性校准情形检出限的确定方法.
GB/T 33260.5-2018 is the Chinese standard "Capability of detection -- Part 5: Methodology in the linear and nonlinear calibration cases". Its scope clause reads: This part of GB/T 33260 is mainly applicable to the case where the calibration function is non-linear and can also be used for linear cases.
The basic methods given in this section are used to. --- Construct a precision profile function of the response variable, a function of the net state variable, using the standard deviation (SD) or variation of the response variable Different coefficient (CV) representation; --- Using the calibration function, the precision profile function of the response variable is transformed into the precision profile function of the net state variable; --- Use the precision profile function of the net state variable to estimate the critical value and the minimum detectable value of the net state variable.
When the method given in GB/T 33260.2-2018 is not effective for the detection of various types of measurement methods (measurement equipment) The methods presented in this section are very useful when evaluating.
This includes measuring the loop by competitive ELISA (enzyme-linked immunosorbent assay) Persistent organic pollutants (POPs, such as dioxin, pesticides and hormonal chemicals) and bacterial toxins that cause high fever.
GB/T 33260.1-2016 and GB/T 33260.2-2018 describe the threshold value of the net state variable and the minimum detectable value Righteousness and applicability.
This section extends the concept in GB/T 33260.2 to a non-linear calibration scenario. Both the critical value xc and the minimum detectable value xd are given in units of net state variables.
If xc and x are defined based on the distribution of response variables Xd, then this definition should include a calibration function that transforms the response variable into a net state variable.
The xc and xd defined in this section are based on the net shape The distribution of state variables is independent of the form of the calibration function. Therefore, this definition applies regardless of whether the function form is linear or non-linear.
The calibration function should be continuous, divisible, and monotonically increasing or decreasing. This section further gives a description of how SD or CV is known only in the neighborhood of the smallest detectable value.
Some examples are given in Chapter 6. Its clauses include terms and definitions.
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Document preview — GB/T 33260.5-2018
National Standard of the People's Republic of China
- ICS
- 03.120.30
- Classification
- A 41
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Precision profile function of the net state variable
- 5 Determination of the critical value of the net state variable and the minimum detectable value
- 5.1 General
- 5.2 Calculation based on probability alpha
- 5.3 Calculation based on probability beta
- 5.4 Differential Method
- 6 Example
- 6.1 Overview
- 6.2 Transmission of uncertainty
- 6.3 Model fitting
- 6.4 Application to Competitive ELISA
- Appendix A (Normative) Symbols and abbreviations in this section
- Appendix B (informative appendix) Derivation of formula (9)
- Appendix C (informative) Derivation of formula (13)
1 Scope
This part of GB/T 33260 is mainly applicable to the case where the calibration function is non-linear and can also be used for linear cases.
The basic methods given in this section are used to.
--- Construct a precision profile function of the response variable, a function of the net state variable, using the standard deviation (SD) or variation of the response variable
Different coefficient (CV) representation;
--- Using the calibration function, the precision profile function of the response variable is transformed into the precision profile function of the net state variable;
--- Use the precision profile function of the net state variable to estimate the critical value and the minimum detectable value of the net state variable.
When the method given in GB/T 33260.2-2018 is not effective for the detection of various types of measurement methods (measurement equipment)
The methods presented in this section are very useful when evaluating. This includes measuring the loop by competitive ELISA (enzyme-linked immunosorbent assay)
Persistent organic pollutants (POPs, such as dioxin, pesticides and hormonal chemicals) and bacterial toxins that cause high fever.
GB/T 33260.1-2016 and GB/T 33260.2-2018 describe the threshold value of the net state variable and the minimum detectable value
Righteousness and applicability. This section extends the concept in GB/T 33260.2 to a non-linear calibration scenario.
Both the critical value xc and the minimum detectable value xd are given in units of net state variables. If xc and x are defined based on the distribution of response variables
Xd, then this definition should include a calibration function that transforms the response variable into a net state variable. The xc and xd defined in this section are based on the net shape
The distribution of state variables is independent of the form of the calibration function. Therefore, this definition applies regardless of whether the function form is linear or non-linear.
The calibration function should be continuous, divisible, and monotonically increasing or decreasing.
This section further gives a description of how SD or CV is known only in the neighborhood of the smallest detectable value.
Some examples are given in Chapter 6.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only dated versions apply.
This document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 3358.1-2009 Statistical vocabulary and symbols - Part 1. General statistical terms and terms for probabilities (ISO 3534-1.2006, IDT)
GB/T 3358.2-2009 Statistical vocabulary and symbols - Part 2. Application statistics (ISO 3534-2.2006, IDT)
GB/T 3358.3-2009 Statistical vocabulary and symbols - Part 3. Experimental design (ISO 3534-3..1999, IDT)
GB/T 6379.1-2004 Accuracy of measurement methods and results (accuracy and precision) Part 1. General and definition (ISO 5725-1.1994, IDT)
GB/T 33260.1-2016 Detection capability Part 1. Terms and definitions (ISO 11843-1.1997, MOD)
GB/T 33260.2-2018 Detection capability Part 2. Methods for determining the ability to detect linear calibrations (ISO 11843-2.
2000, MOD)
3 Terms and definitions
GB/T 2829 | GB/T 6379.6 | GB/T 2828.2 | GB/T 33260.4 | GB/T 33260.3 | GB/T 33260.2 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 3358.1-2009Statistics -- Vocabulary and symbols -- Part 1: General statistical terms and terms used in probability
- GB/T 3358.2-2009Statistics -- Vocabulary and symbols -- Part 2: Applied statistics
- GB/T 3358.3-2009Statistics -- Vocabulary and symbols -- Part 3: Design of experiments
- GB/T 6379.1-2004Accuracy (trueness and precision) of measurement methods and results -- Part 1: General principles and definitions
- GB/T 33260.1-2016Capability of detection -- Part 1: Terms and definitions
- GB/T 33260.2-2018Capability of detection -- Part 2: Methodology in the linear calibration case
ISO 3534 · ISO 5725 · ISO 11843
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Related Standards
GB/T 33260.1-2016 — Capability of detection -- Part 1: Terms and definitions
GB/T 33260.2-2018 — Capability of detection -- Part 2: Methodology in the linear calibration case
GB/T 3358.1-2009 — Statistics -- Vocabulary and symbols -- Part 1: General statistical terms and terms used in probability
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GB/T 33260.5-2018
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