WS/T 459-2018 in English

VALID

Common used serum tumor marker tests:clinical practice and quality management

Issued on:2018-12-11
Implemented on:2019-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $370.00
$359.00

Standard No:	WS/T 459-2018
Document status:	VALID
Title in English:	Common used serum tumor marker tests:clinical practice and quality management
Title in Chinese:	常用血清肿瘤标志物检测的临床应用和质量管理
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-12-11
Implemented on:	2019-06-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Topics:	serum the tumor Clinical application for clinical chemistry control serum landmark food serum testing Clinical application Marker detection Tumor markers serum concentration Clinically tested in milliliters tumor tumor test serum tumor antigen Tumor Two Quantification Serum by Flow Cytometry broad spectrum of tumor markers Tumor markers Tumor surgery broad-spectrum tumors test serum double serum test Physical Measurement - Applied Physics Seven tumor markers cancer screening cancer screening commonly used detection clinical tumor antigen serum test multiple tumor markers Clinical application of exosomes medullary carcinoma Tumor markers 20 times clinical dosage serum indicators Bedside testing quality management Separate serum 14 tumor markers clinical serum non-routine blood tests detection clinical 17 tumor markers Tumor marker 50 Abnormal biomarkers broad-spectrum tumor markers neuronal enolase WS/T404-2018 Antu Bioclinical Mass Spectrometry Detection Detecting markers of angiogenesis Normal saline for serum Development history of clinical application of mass spectrometry Tumor marker cutoff value Clinical application of test tube agglutination reaction Clinical method for determination of serum inorganic phosphorus neuron-specific enolase Which test is used to detect serum IL8? Lewis blood type NB/70K tumor marker WS T 586 2018 Instruments for measuring tumor markers Clinical significance of serum magnesium determination Tumor vascular experiment Clinical mass spectrometry related Hematoma detection equipment Clinical mass spectrometry related detection Commonly used quantitative detection methods What are the commonly used biomass detection methods? Tumor microbial detection methods Quality control serum and standard serum Tumor antigen detection methods Clinical use of commonly used ototoxic drugs Serum selenium detection standard document Tumorsphere detection method Serum mass spectrometry clinical standard method Tumor marker analysis and detection methods Tumor marker research methods Detection method tumor marker range Standard serum quality requirements Principles and methods of clinical detection of blood lithium

本标准规定了常用血清肿瘤标志物检测的临床应用和质量管理要求。
本标准适用于临床实验室以及研制和生产肿瘤标志物试剂的单位。

Introduction

Analysis of the core content of the standard

Markers	Main application tumors	Diagnostic cut-off value	Recommendation for combined detection
AFP	Primary liver cancer	400μg/L for 1 month	Ultrasound examination
CEA	Colorectal cancer/lung cancer	Method dependence	Imaging examination
NSE	Small cell lung cancer	Method dependence	ProGRP combined

Key technical requirements

Pre-analytical quality control: Avoid hemolysis (especially NSE detection requires centrifugation within 60 minutes), prevent sweat contamination (affects SCC), pay attention to physiological increases during pregnancy (AFP can exceed 1000μg/L)

Detection system validation: Need to verify precision (intra-batch CV <5%), accuracy (recovery rate 90-110%) and measurement range (including medical decision levels)

Clinical application warnings

ProGRP detection needs to exclude renal function interference (false positive rate increases when GFR <60)
CA19-9 has no diagnostic value in Lewis antigen-negative individuals (3-7%).
Transient NSE elevation may occur 24-72 hours after chemotherapy (tumor lysis).

Implementation recommendations

Establish laboratory-specific reference intervals (variation between different methods can reach 30%).
Screening plan for high-risk groups: HBV carriers should undergo combined monitoring with AFP and ultrasound every 6 months.
Frequency of recurrence monitoring: Every 3 months within 2 years after surgery, and every 6 months for 3-5 years.

More samples: JC/T 2453-2018 DL/T 368-2010 YD/T 3934-2021

Sample only — not a preview of WS/T 459-2018

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

WS/T 573-2018 in English

Algorithm and report of immunological testing for infectious diseases
2018-04-27
WS/T 493-2017 in English

Guide to the estimation of the measurement uncertainty of reference methods in enzymology reference laboratiories
2017-09-06
WS/T 472-2015 in English

Oral health survey―Examination methods
2015-09-17
WS/T 645.1-2018 in English

Reference intervals for common clinical immunology tests Part 1:Serum immunoglobulin G, immunoglobulin A,immunoglobulin M, Complement 3,Complement 4
2018-12-12
WS/T 505-2017 in English

Guideline for evaluation of qualitative test performance
2017-09-06
WS/T 407-2012 in English

Guideline for comparability verification of quantitative results within one health care system
2012-12-25
WS/T 404.3-2012 in English

Reference intervals for common clinical biochemistry tests—Part 3:Serum potassium,sodium and chloride
2012-12-25