Standards

WS/T 489-2016 Replaced

WS/T 489-2016 Laboratory diagnosis of urinary tract infections

This standard specifies the technical requirements for the clinical microbiological examination of urine samples.
This standard is applicable to microbiological laboratories that conduct bacterial culture, identification, and drug sensitivity tests on urine samples.

Publish Date: 2016-07-07

WS/T 491-2016 Replaced

WS/T 491-2016 Guideline of test method of non-specific antibodies for treponemal pallidum infection

This standard specifies the methods for detecting non-specific antibodies to syphilis, the steps of the test operation, the description and presentation of the results, quality control, etc.
This standard is applicable to all types of laboratories that conduct non-specific antibody detection for syphilis.

Publish Date: 2016-07-07

WS/T 492-2016 Replaced

WS/T 492-2016 Verification of performance for precision and trueness of quantitative measurements in clinical laboratories

This standard specifies the procedures for evaluating the precision and accuracy of quantitative measurement items in clinical laboratories.
This standard is applicable to clinical laboratories.

Publish Date: 2016-07-07

WS/T 478-2015 Replaced

WS/T 478-2015 Operating guidelines for measurement of serum 25-hydroxyvitamin D3—Isotope dilution liquid chromatography tandem mass spectrometry

This standard specifies the technical requirements for the routine method of detecting 25-hydroxyvitamin D3 in serum - isotope dilution liquid chromatography-tandem mass spectrometry, including reagent preparation, sample preparation, instrument detection, data analysis, and other aspects.
This standard is applicable to routine laboratory detection of 25-hydroxyvitamin D3 in serum using isotope dilution liquid chromatography-tandem mass spectrometry.

Publish Date: 2015-11-06

WS/T 461-2015 Replaced

WS/T 461-2015 Measurement of Hemoglobin A1c

This standard specifies the detection and quality assurance of glycated hemoglobin.
This standard is applicable to clinical laboratories and laboratories engaged in epidemiological research for the detection of glycated hemoglobin. Reagent or instrument manufacturers may refer to it for use.

Publish Date: 2015-06-23

WS/T 458-2014 Replaced

WS/T 458-2014 General guidelines for rapid detection of health supervision

This standard specifies the requirements for the organization, systems, personnel, facilities, equipment, methods, reagents and consumables, quality assurance, work planning and preparation, on-site testing, and result reporting for rapid on-site detection work in health supervision.
This standard applies to the rapid on-site detection work conducted by health supervision agencies at all levels.

Publish Date: 2014-09-24

WS/T 416-2013 Replaced

WS/T 416-2013 Guide to interference testing in clinical chemistry

This standard specifies the method for evaluating the impact of interfering substances on the detection system.
This standard is applicable to manufacturers of in vitro diagnostic medical devices and clinical laboratories for evaluating the interference of clinical laboratory quantitative methods.

Publish Date: 2013-07-16

WS/T 418-2013 Replaced

WS/T 418-2013 Guidelines for the selection of referral clinical laboratories

This standard specifies the management and technical requirements for the selection of entrusted clinical laboratories.
This standard applies to the activities of entrusted laboratories or clinical testing applicants in selecting and evaluating the services of entrusted clinical laboratories. Entrusted clinical laboratories may also refer to it for internal management purposes.

Publish Date: 2013-07-16

WS/T 420-2013 Replaced

WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

This standard specifies the methods for clinical laboratories to verify the analytical performance of commercial quantitative reagent kits.
This standard applies to the verification of the analytical performance of commercial quantitative reagent kits in clinical laboratories. For some commercial quantitative reagent kits, this standard may not be fully applicable, and appropriate modifications can be made based on this standard.
This standard is not applicable to a comprehensive and systematic evaluation of the analytical performance of commercial quantitative reagent kits. If clinical laboratories have made significant modifications to the operating steps, dosages, calculations, etc. of commercial quantitative reagent kits, it is not sufficient to conduct only verification. In this case, more comprehensive and complex validation methods should be used.

Publish Date: 2013-07-16

WS/T 409-2013 Replaced

WS/T 409-2013 Estimation of total analytical error for clinical laboratory methods

This standard specifies the determination, expression, monitoring, and examples of total analytical errors in clinical detection methods.
This standard applies to all quantitative analysis methods in clinical detection.

Publish Date: 2013-06-03

WS/T 413-2013 Replaced

WS/T 413-2013 Reference mesurement method for serum creatinine—Isotope dilution liquid chromatography tandem mass spectrometry

This standard specifies the technical requirements for the reference method of serum creatinine measurement, including sample collection and processing, instrument measurement, data analysis, and uncertainty analysis.
This standard is applicable to the measurement of serum creatinine in laboratories.

Publish Date: 2013-06-03

WS/T 414-2013 Replaced

WS/T 414-2013 Guideline for application of the results from external quality assessment

This standard specifies the application of inter-laboratory quality evaluation results in improving the work of clinical laboratories.
This standard is applicable to clinical laboratories in medical institutions.

Publish Date: 2013-06-03