YY/T 1789.1-2021In vitro diagnostic test systems-Performance evaluation method - Part 1: Precision (English PDF)
体外诊断检验系统 性能评价方法 第1部分：精密度
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
March 1, 2023
Scope
YY/T 1789.1-2021 is the English-translated version of 体外诊断检验系统 性能评价方法 第1部分：精密度.
YY/T 1789.1-2021 is the Chinese pharmaceutical industry standard that gives the method by which a manufacturer evaluates the precision of an in vitro diagnostic test system.
It is the first part of the YY/T 1789 series and sets out the experimental design - the samples, the number of runs and days, the replicates - and the calculation of repeatability and within-laboratory precision from the results, together with the acceptance of the figures obtained.
It applies to quantitative systems, and not to those whose result is nominal or ordinal, such as blood cell identification, microbial typing, nucleic acid sequence identification or urine particle identification, or results reported as negative, positive or 1, 2, 3. Issued on 6 September 2021, it has applied since 1 March 2023.
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Document preview — YY/T 1789.1-2021
National Standard of the People's Republic of China
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Symbols and Abbreviations
- 5 General
- 5.1 General Requirements
- 5.2 Precision Type
- 5.3 Sample Requirements
- 5.4 Products to be evaluated
- 5.5 Evaluation Process
- 5.5.1 Flowchart
- 5.5.2 Analysis of Influencing Factors
- 5.5.3 Evaluation scheme design
- 5.5.4 Precautions for testing
- 5.5.5 Data Analysis
- 5.5.6 Results report
- 6 Evaluation of Repeatability and Intralaboratory Precision
- 6.1 Test
- 6.2 Data Inspection and Analysis
- 6.2.1 Outlier test
- 6.2.2 Calculation of SS, MS
- 6.2.3 Computing s and CV
- 6.2.4 Computing confidence intervals
- 6.2.5 Example
- 7 Interlaboratory Precision Evaluation
- 7.1 Test
- 7.2 Data Inspection and Analysis
- 7.2.1 Outlier tests
- 7.2.2 Calculation of SS, DF, MS
- 7.2.3 Computing s and CV
- 7.2.4 Computing confidence intervals
- 7.2.5 Example
- Appendix A (informative) Example of data analysis for repeatability and intra-laboratory precision evaluation (in the case of data balance)
- Appendix B (Informative Appendix) Example of Interlaboratory Precision Evaluation Data Analysis (In the case of data balance)
- Reference
Foreword
YY/T 1789 "In Vitro Diagnostic Test System Performance Evaluation Method", consists of the following parts.
--- In vitro diagnostic test system performance evaluation method Part 1: Precision;
--- In vitro diagnostic test system performance evaluation method Part 2: Accuracy;
--- In vitro diagnostic test system performance evaluation method Part 3.detection limit and quantification limit;
--- In vitro diagnostic test system performance evaluation method Part 4: Linear interval and reportable interval;
--- In vitro diagnostic test system performance evaluation method Part 5: Analysis specificity;
---In vitro diagnostic test system performance evaluation method Part 6: Precision of qualitative reagents, diagnostic sensitivity and specificity, predictive measured value. This part is Part 1 of YY/T 1789.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This part of YY/T 1789 specifies the method for evaluating the precision performance of in vitro diagnostic testing systems.
This section applies to the manufacturer's evaluation of the precision of in vitro diagnostic test systems for quantitative testing.
This section does not apply to the performance evaluation of in vitro diagnostic test systems with results reported as nominal and ordinal scales, such as for blood cells Cell identification, microbial typing, nucleic acid sequence identification, urine particle identification, and the results are reported as negative, positive or in vitro diagnosis of 1, 2, 3 Inspection system.
This section does not apply to medical laboratory precision performance verification, nor does it apply to product type inspection.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 4883-2008 Statistical processing and interpretation of data Judgment and processing of outliers in normal samples
GB/T 6379.2 Accuracy (correctness and precision) of measurement methods and results - Part 2: Determining repetition of standard measurement methods Basic Methods of Reproducibility and Reproducibility
YY/T 1441 General requirements for performance evaluation of in vitro diagnostic medical devices
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 IVD medical device
Devices used alone or in combination, intended by the manufacturer for the in vitro testing of human specimens, solely or primarily for the purpose of providing diagnosis, monitoring or compatibility information, devices including reagents, calibrators, control substances, sample containers, software and related instruments or devices or other thing. [GB/T 29791.1-2013, definition 3.27]
3.2 IVD Instrument
A device or device intended by the manufacturer for use as an in vitro diagnostic medical device. [GB/T 29791.1-2013, definition 3.26]
3.3 IVD reagent
A chemical, biological or immunological component, solution or preparation intended by the manufacturer for use as an in vitro diagnostic medical device.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 4883-2008Statistical interpretation of data - Detection and treatment of outliers in the normal sample
- GB/T 6379.2Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
- YY/T 1441General requirements of performance evaluation of in vitro diagnostic medical devices
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Related Standards
GB/T 4883-2008 — Statistical interpretation of data - Detection and treatment of outliers in the normal sample
GB/T 6379.2-2004 — Measurement methods and results -- Accuracy (trueness and precision) -- Part 2: Determine the standard methods of measurement repeatability and reproducibility of the basic method
GB/T 6379.2-2026 — Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
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