WS/T 228-2002
Preliminary evaluation of quantitative clinical laboratory methods (English Version)

Standard No.

WS/T 228-2002

Language

Chinese, Available in English version

Release Date

2002

Published By

中华人民共和国国家卫生和计划生育委员会

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WS/T 228-2002

Scope

Before a new method, new reagent, or new instrument is used for in vitro diagnostics, it is often necessary to make a preliminary decision on its acceptability. This preliminary method performance check is neither a rigorous evaluation of the long-term performance of the method nor an evaluation of the many factors that influence the results produced by the equipment. The primary goal of this standard is to help identify problems and require immediate correction, consultation with the manufacturer, or further evaluation. This standard specifies a method for preliminary evaluation of linearity, bias, linear drift, sample cross-contamination and precision of clinical testing methods. A preliminary evaluation must be performed before a new method is used to test patient samples, or after any modifications to the method are made. These tests are intended for the evaluation of automated instruments but may also be used for the evaluation of kits, manual methods, or other in vitro diagnostic devices. Only repeat experiments on 10 samples. By plotting the experimental points and making some simple calculations, the performance characteristics can be evaluated. Using multiple linear regression analysis statistical techniques, further information on factors affecting imprecision (such as sample cross-contamination and linear drift) can be obtained. No computer is required because instructions for simple data analysis are provided. This test is used for a preliminary estimate of the instrument's performance characteristics to determine the final acceptability of the device. The test results can only determine whether the device has serious unacceptable performance. The materials and methods used are briefly described in the standard. There may be many changes to this basic experiment (such as extending the experimental days, removing problematic samples). Varies with the complexity of the device, the nature of the method, and the resources available to the user.

WS/T 228-2002 history

• 2002 WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods