WS/T 573-2018 in English

VALID

Algorithm and report of immunological testing for infectious diseases

Issued on:2018-04-27
Implemented on:2018-11-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $130.00
$127.00

Standard No:	WS/T 573-2018
Document status:	VALID
Title in English:	Algorithm and report of immunological testing for infectious diseases
Title in Chinese:	感染性疾病免疫测定程序及结果报告
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-04-27
Implemented on:	2018-11-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Topics:	disease Infect immunity Infectious disease Sequencing results immunity to infection immunity? Test immunity Qualitative test report dna disease Organic Qualitative Test Report disease instrument How to combine the sequencing results with the original results autoimmune disease Autoimmune Disease+ Methodology for Reporting Qualitative Results Test Report Results Test data and results Sequencing result peak Result test report Determination method report Type IV immune disease result report autoimmune disease Infectious Disease Detection Colocalization results Autoimmune Disease Flow Cytometry disease product Infectious Disease Detection Methods 14 autoimmune diseases systemic immune disease innate immunity Infectious Diseases immune engineering detect infection infection and immunity detect infection autoimmune infection immunity Pathogen infection immune engineering Infectious Diseases infectious disease Diseases and Infections During Pregnancy idiopathic disease report first results nuts report Sensor Test Results Calibration result Quarantine report Fruit test report innate immune system Fourteen autoimmune diseases test result procedure Equipment test result report Results and conclusions 12 immune diseases congenital disease Secondary Results Report Three types of immune diseases low immunity immunity to infectious diseases Peptide sequencing results Sequencing result nesting immunofluorescence immunofluorescence WS/T404-2018 Can the test report result be reported as 0? Immunofluorescence staining results analysis Analysis of illumina sequencing results TMAO and immune diseases tunel staining results Analysis of monoclonal antibody sequencing results Optical rotation and its measurement experiment report dapi staining results WS T 586 2018 Result announcement thermo U3000 Immunofluorescence result determination method Quantitative Immunology Industry Norovirus infection cluster epidemic

本标准规定了感染性疾病免疫测定的临床检测程序、结果报告及解释。
本标准适用于开展各种感染性疾病免疫测定的医学实验室。

Introduction

Analysis of the Standard's Core Content

This standard systematically regulates the three core aspects of infectious disease immunoassays: Clinical Testing Procedure Establishment, Result Reporting Standards, and Clinical Interpretation Key Points. It is applicable to all medical laboratories conducting tests such as enzyme-linked immunosorbent assays and chemiluminescent immunoassays.

Specifications for establishing detection procedures

Test type	Sensitivity requirement	Specificity requirement	Typical method
Screening test	≥95%	Depending on clinical impact	ELISA, immunochromatography
Diagnostic test	≥90%	≥85%	Chemiluminescence, fluorescent immunoassay
Confirmatory test	Not mandatory requirement	≥98%	Western Blot, nucleic acid detection

Key technical points

1. Processing flow for positive screening test

When a positive result is detected by chemiluminescence analyzer:

Positive predictive value > 95%: Direct report is allowed but the risk of false positive must be noted
Positive predictive value < 95%: Confirmation by protein immunoblotting is required
Hemolyzed/contaminated samples: Strictly implement the resampling system

2. Processing plan for indeterminate results

Taking HCV detection as an example:

When the first WB test is indeterminate, a follow-up visit should be arranged after 3 months
Combined with HCV

Daily testing volume for screening tests ≥ 200 samples
Confirmatory test turnaround time ≤ 3 working days

2. Key Quality Control Points

Establish a three-level quality control system:

Daily operation of commercial quality control products
Monthly external quality assessment
Quarterly method comparison

3. Report Template Specifications

 [Test Item] HIV Antibody Screening Test [Test Method] Chemiluminescence [Test result] Positive (COI=18.6) [Clinical recommendation] Western Blot confirmation test is recommended. If the confirmation test is still inconclusive, follow-up after 3 months is recommended [Lower limit of detection] 0.5 IU/mL

More samples: QC/T 942-2021 JJG 21-2008 DL/T 368-2010

Sample only — not a preview of WS/T 573-2018

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