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WS/T 409-2024: Evaluation of analytical total error for quantitative clinical laboratory methods
Status: Valid
WS/T 409: Evolution and historical versions
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| WS/T 409-2024 | English | 289 |
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Evaluation of analytical total error for quantitative clinical laboratory methods
| Valid |
| WS/T 409-2013 | English | 639 |
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Estimation of total analytical error for clinical laboratory methods
| Obsolete |
Basic data
| Standard ID | WS/T 409-2024 (WS/T409-2024) |
| Description (Translated English) | Evaluation of analytical total error for quantitative clinical laboratory methods |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Classification of International Standard | 11.020 |
| Word Count Estimation | 13,148 |
| Date of Issue | 2024-05-09 |
| Date of Implementation | 2024-11-01 |
| Older Standard (superseded by this standard) | WS/T 409-2013 |
| Issuing agency(ies) | National Health Commission |
| Summary | This standard specifies the method for evaluating the total error of analysis of clinical quantitative detection methods. This standard is applicable to the evaluation of the total error of analysis of quantitative detection methods by clinical laboratories, instrument or reagent manufacturers in the process of establishing detection methods. |
WS/T 409-2013: Estimation of total analytical error for clinical laboratory methods
---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.
Estimation of total analytical error for clinical laboratory methods
ICS 11.020
C50
People's Republic of China health industry standards
Determination of the total analysis error of clinical testing methods
2013-06-03 released
2013-12-01 Implementation
People's Republic of China National Health and Family Planning Commission released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Capital Medical University Beijing Chaoyang Hospital, Ministry of Health Clinical Laboratory, Beijing Aerospace General Hospital.
The main drafters of this standard. Wang Qingtao, Tong Qing, Li Xiaopeng, Wang Zhiguo, Shen Ziyu, Yang Zhenhua, Zhang Jianping, Chen Baorong.
Determination of the total analysis error of clinical testing methods
1 Scope
This standard specifies the clinical testing methods to determine the total analysis of error, expression, monitoring and examples.
This standard applies to all clinical testing quantitative analysis.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Allow interval toleranceinterval
At the specified level of confidence, the overall proportion of the sampling area specified.
2.2
Total analysis error totalanalyticalerror
Between detection methods and reference methods, the concentration differences are distributed over the ranges encompassed by the specified ratio (usually 90%, 95% or 99%).
2.3
Confirm the validation
Identification of requirements that have been met by providing objective evidence of a specific intended use or application.
[ISO 9000..2000, definition 3.8.5]
3 Data collection
3.1 Samples should come from healthy people or patients, the sample should be representative of routine testing samples, and should be determined within the medical level
Uniform distribution. All extracted samples should be included in the analysis.
3.2 The minimum sample size used in clinical laboratories should be 40 cases. Each analysis should be the appropriate number of samples tested, using the same batch determination
The one-time result determined the total analysis error. Repeated measurements can also be performed to reduce the impact of the reference method imprecision on the overall analysis error assessment.
The sample size used by the manufacturer should be 120, it is advisable to analyze more samples and use all the data to determine the total analysis error.
3.3 It is advisable to use fresh samples, which can also be used if the stored samples have no effect on the analysis. The sample concentration should cover the analytical measurement range; for
Different concentration ranges set different total analysis error targets.
3.4 Before determining the total analysis error should be checked deviation of the observed value (outliers) is wrong, if you confirm this error can be deleted, or should
Keep.
4 total analysis of the error is determined
4.1 Non-parametric analysis method
Nonparametric analysis did not make any assumptions about the overall distribution of the difference.
The non-parametric analysis method is used to determine the total analysis error. n pairs of observations are obtained from the measurement results of the candidate method and the comparison method,
And get the difference of n pairs of observations, that is, the number of samples is n. Will be n difference in ascending order, the difference after sorting to x1, xn said;
Calculate the rank of each xn; then divide the rank by (sample number 1) to get the percentile for each rank; for all percentiles that exceed 0.5
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