|
US$479.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1789.2-2021: In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1789.2-2021 | English | 479 |
Add to Cart
|
5 days [Need to translate]
|
In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
| Valid |
YY/T 1789.2-2021
|
PDF similar to YY/T 1789.2-2021
Basic data | Standard ID | YY/T 1789.2-2021 (YY/T1789.2-2021) | | Description (Translated English) | In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 25,262 | | Issuing agency(ies) | State Drug Administration | YY/T 1789.2-2021: In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
---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.
In vitro diagnostic test systems -- Performance evaluation method -- Part 2: Trueness
ICS 11:100:10
C30
People's Republic of China Pharmaceutical Industry Standard
Performance evaluation method of in vitro diagnostic test system
Part 2: Correctness
Part 2:Trueness
Published on 2021-12-06
2023-05-01 Implementation
Released by the State Drug Administration
content
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 General 2
4:1 General Requirements 2
4:2 Correctness evaluation method 2
4:3 Products to be evaluated 3
4:4 Test Notes 3
4:5 Data Analysis 3
5 Evaluation of the correctness of the use of reference substances 3
5:1 Reference material requirements3
5:2 Test time and number of tests 3
5:3 Data Analysis 3
5:3:1 Bias Estimation 3
5:3:2 Calculating confidence intervals 3
5:3:3 Example 4
6 Evaluation of correctness using patient samples4
6:1 Sample Requirements 4
6:2 Choice of Comparison Method 4
6:3 Test time and number of tests 4
6:4 Data Analysis 4
6:4:1 Scatter or Deviation Plot 4
6:4:2 Outlier Test 5
6:4:3 Preliminary estimates of bias 5
6:4:4 Regression Analysis 5
6:4:5 Bias at the medical decision level 5
6:4:6 Data Analysis Example 6
7 Recovery test 7
7:1 Applicable conditions 7
7:2 Test method 7
7:3 Data Analysis 7
Appendix A (Informative Appendix) Example of Data Analysis for Correctness Evaluation Using Reference Substances 8
Appendix B (Informative) Example of Data Analysis for Correctness Assessment Using Patient Samples 10
Reference 20
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 testing system performance evaluation method Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents:
This part is Part 2 of YY/T 1789:
This section is drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents:
This part is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136):
This section is drafted by: Beijing Medical Device Inspection Institute, Meikang Biotechnology Co:, Ltd:, Sysmex Medical Electronics (Shanghai)
Co:, Ltd:, Shanghai Clinical Testing Center, Beijing Medical Device Technology Review Center, China National Institute for Food and Drug Control, Mike Biotechnology Co:, Ltd:
Co:, Ltd:, Zhengzhou Antu Biological Engineering Co:, Ltd:, Aiwei Technology Co:, Ltd:, Beckman Coulter Trading (China) Co:, Ltd:
Company, Soling Diagnostic Medical Equipment (Shanghai) Co:, Ltd:
The main drafters of this section: Wang Jun, Shen Min, Yang Zongbing, Wang Hualiang, Sun Rong, Qu Shoufang, Sun Keqi, Li Zhongxin, Zhou Fengliang, Yang Yuejuan,
Wang Chengmei:
Introduction
In the performance evaluation of in vitro diagnostic medical device products, in vitro diagnostic instruments, reagents, calibrators, etc:
Therefore, this series of standards adopts the concept of system to describe the performance of the measurement system composed of instruments, reagents, calibrators, etc:
Evaluation of analytical performance refers to an estimate of the reliability of a measurement system to detect patient samples: Analytical performance of in vitro diagnostic test systems
Including precision, correctness, accuracy, detection limit and quantification limit, linear interval and reportable interval, analytical specificity, etc:
Measurement correctness is a performance characteristic that evaluates systematic measurement error in a series of measurements of a homogeneous sample: Correctness is a qualitative
notion, but measurement bias can be assessed: Assessment of bias requires an appropriate reference substance or reference measurement procedure that can be used to determine the value of the reference quantity being measured:
sequence: Correctness is to be distinguished from "accuracy": Accuracy is the difference between a measured quantity and the true quantity being measured:
The error includes the systematic measurement error component estimated by the measurement bias and the random measurement error component estimated by the standard deviation, and the accuracy is the correctness and precision:
combination of densities:
In general, the accuracy evaluation is carried out only after the precision evaluation of the measurement system and the requirements are met: This section provides three positive
Accuracy evaluation methods, the first method is to analyze an appropriate reference material with the value of the reference quantity to be measured, and the second method is to use patient samples for
The third method is to use the recovery test: Evaluate the correctness and estimate the bias, the purpose of which is to know the magnitude of the bias:
small and correct as needed:
Performance evaluation method of in vitro diagnostic test system
Part 2: Correctness
1 Scope
This part of YY/T 1789 specifies the method for evaluating the correctness performance of in vitro diagnostic test systems:
This section applies to the manufacturer's evaluation of the correctness of in vitro diagnostic test systems for quantitative testing:
This section does not apply to in vitro diagnostic test systems in which results are reported as nominal and ordinal scales, such as for blood cell identification, microbiological
Characterization of the in vitro diagnostic test system for genotyping, nucleic acid sequence identification, urine particle identification, and results reported as negative, positive, or 1, 2, and 3
can evaluate: This section also does not apply to qualitative in vitro diagnostic test systems (such as enzyme-linked immunosorbent assays) that are based on quantitative measurements and judge the results by thresholds:
The performance evaluation of the pathogenic microorganism antigen or antibody detection kit by immunosorbent method:
This section does not apply to medical laboratory accuracy 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 article
pieces: For undated references, the latest edition (including all amendments) applies to this document:
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
measurementsbias
bias
An estimate of the systematic measurement error:
Note 1: Bias is inversely related to accuracy:
Note 2: The estimate of bias is the mean of a series of measurements minus the reference value:
[GB/T 29791:1-2013, Definition A:3:25]
3:2
measurementtrueness
trueness
The degree of agreement between the mean value of an infinite number of repeated measurements and a reference value:
Note 1 to entry: Measurement accuracy is not a quantity and therefore cannot be expressed numerically: A measure of the degree of conformity is given in GB/T 6379:3:
Note 2: The measurement accuracy is inversely related to the systematic measurement error, but not to the random measurement error:
Note 3: The term measurement accuracy should not be used to measure correctness, and vice versa:
[GB/T 29791:1-2013, Definition A:3:34]
3:3
referencemeasurementprocedure
Accepted as a measurement procedure that provides measurement results suitable for its intended use including the evaluation of other methods of measuring the same quantity
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1789.2-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1789.2-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 1789.2-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1789.2-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|