WS/T 645.2-2018 in English

VALID

Reference intervals for common clinical immunology tests Part 2: Serum a-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 19-9，carbohydrate antigen 15-3, carbohydrate antigen 125

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

Price(USD)： $190.00
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Standard No:	WS/T 645.2-2018
Document status:	VALID
Title in English:	Reference intervals for common clinical immunology tests Part 2: Serum a-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 19-9，carbohydrate antigen 15-3, carbohydrate antigen 125
Title in Chinese:	临床常用免疫学检验项目参考区间第2部分:血清甲胎蛋白、癌胚抗原、糖链抗原19-9、糖链抗原15-3、糖链抗原125(发布稿)
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-12-12
Implemented on:	2019-06-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Keywords:	carcinoembryonic antigen carbohydrate antigen 19-9，carbohydrate antigen standard item unit upper reference limit key reference intervals
Related Topics:	sugar antigen Carbon Spectrum of Sugar Chains Secondary Antibody Single Chain Antibody antigen ca Secondary Antigen protein antigen sugar chain sugar chains in glycoproteins Immunization test items Antigen detection flow cytometry sugar chain energy protein antigen Carcinoembryonic antigen non-collagenous glycoprotein collagen glycoprotein Glycoprotein chain collagen glycoprotein Non-collagen Glycoprotein+ antigenic peptide antigen Glycoprotein abnormalities heavy chain secondary antibody Glycoprotein sugar chain Antigen+ Antigen analysis glycan chain sugar chains in glycoproteins Glycoprotein sugar chain immunological test afp alpha-fetoprotein heavy chain secondary antibody serum test Antigen a Antigen analysis flow detection antibody antigen flow antigen detection Antigen Antibody Conditions cea carcinoembryonic antigen antigen immune peptide Separate serum immunodominant antigen antigenic protein Sugar Chains and Glycosylation alpha-fetoprotein afp hapten carcinoembryonic antigen sugar chain mass spectrometry carbohydrate antigen 50 carbohydrate antigen 15-3 anti-collagen antiserum antigen sugar chains and peptide chains in glycoproteins carbohydrate antigen 19- cea carcinoembryonic antigen carbohydrate antigen 50 and More than 90,000 surface antigens WS/T404-2018 WS T 586 2018 Chain code principle Antigen labeled SDS The difference between antigenicity and immunogenicity Immunogenicity Reference Principles and methods of clinical detection of blood lithium

本部分规定了中国成人（≥18 岁）血清甲胎蛋白、癌胚抗原、糖链抗原 19-9、糖链抗原 15-3、糖链抗原 125 的参考区间及其应用。
本部分适用于医疗卫生机构临床实验室对血清甲胎蛋白、癌胚抗原、糖链抗原 19-9、糖链抗原 15-3、糖链抗原 125 检验结果的报告，相关体外诊断产品生产厂商可参照使用。

Introduction

Analysis of the core content of the standard

Item	Unit	Upper reference limit	Key differences
Alpha-fetoprotein (AFP)	ng/mL	≤7	Harmonized standard (Traceable to WHO 72/225)
Carcinoembryonic antigen (CEA)	ng/mL	≤5	Harmonized standard (Traceable to WHO 73/601)
CA19-9	U/mL	25-43	Significant differences between systems (Roche/Beckman, etc.)

Background of Technical Evolution

This standard establishes multi-center data of the Chinese population for the first time (six regions including Northeast China, North China, and East China), achieving the following breakthroughs:

Screening of 18,000 healthy people: strictly excluding confounding factors such as abnormal BMI and chronic diseases

CA125 was double-grouped by sex + age for the first time (the threshold difference between pre- and post-menopausal women was 47→25 U/mL)

Parallel validation by four mainstream detection systems (Roche/Beckman/Siemens/Abbott)

Key Points of Clinical Application

Case Comparison: Interpretation of Abnormal CA125

52-year-old female patient with a test value of 28U/mL:

Using System a (Roche): Within the reference interval (≤25U/mL)

Using System d (Abbott): Exceeding the threshold (＞22U/mL)

Handling Suggestions: Must be judged in combination with the type of detection system, and methodological comparison should be performed when necessary

Implementation of Validation Specifications

Sample Requirements: ≥20 healthy controls (balanced in gender and age)

Outlier Handling: Use the Dixon method (eliminate cases with D/R ≥1/3)

Passing criteria: Outliers ≤ 10% (n ≥ 20) or ≤ 2 (n = 20)

More samples: JGJ 94-2008 GB 50021-2001(2009) JC/T 2453-2018

Sample only — not a preview of WS/T 645.2-2018

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