WS/T 834-2024 in English

VALID

Clinical application of tests for Toxoplasma gondii

Issued on:2024-04-02
Implemented on:2024-09-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	WS/T 834-2024
Document status:	VALID
Title in English:	Clinical application of tests for Toxoplasma gondii
Title in Chinese:	刚地弓形虫试验临床应用
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2024-04-02
Implemented on:	2024-09-01
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Keywords:	toxoplasma infection specimen management basic collection requirements gondii introduction core changes clinical application occurrence clinical significance igm specimens detection technology conventional pcr new next-generation
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本标准规定了临床实验室刚地弓形虫试验及其临床应用，主要包括生物安全、标本的采集转运和处理、检验方法、质量控制和免疫学试验的临床应用。
本标准适用于临床实验室开展刚地弓形虫的检测。

Introduction

Core changes in the standard revision

Revision dimensions	2013 version	Current standard
Terminology	2 core terms	New definition of Toxoplasma infection
Specimen management	Basic collection requirements	Detailed processing specifications for 5 types of specimens
Detection technology	Conventional PCR	New Next-generation sequencing technology

Key detection technical specifications

1. Etiological examination

Direct microscopic examination Note: After Giemsa staining, tachyzoites are crescent-shaped (3-7×2-4μm), with blue cytoplasm and purple-red nuclei. The thickness of tissue sections should be controlled at 7-10μm.

2. Nucleic acid detection

Recommended target gene priority: B1 gene＞AF146527＞SAG1. When the real-time fluorescence PCR cycle threshold (Ct value) is ＞35, it should be interpreted with caution.

3. Antibody Testing

Antibody Type	Time of Occurrence	Clinical Significance
IgM	1 week after infection	A marker of the acute phase, may continue to have false positives
IgG	1-2 weeks	Avidity testing can distinguish recent/past infection

Laboratory Grading Implementation Plan

Required Capabilities of Initial Screening Laboratories

At least conduct IgG/IgM combined testing
Chemiluminescence assay (CLIA) is preferred
Suspicious samples should be sent to the confirmation laboratory

Additional requirements for confirmation laboratories

Need to have the ability to pathological examination
Nucleic acid detection specificity>>98%
Tissue culture (optional)

Special population testing strategy

Pregnant screening:IgG/IgM screening should be completed in early pregnancy, and IgG affinity testing should be performed if IgM is positive. Amniotic fluid PCR is recommended to be performed after 18 weeks of pregnancy.

HIV-infected people:When CD4+<100/μL, IgG positive indicates the risk of reactivation, and regular monitoring of blood nucleic acid is recommended.

More samples: DL/T 368-2010 NB/T 47013.2-2015 JC/T 2453-2018

Sample only — not a preview of WS/T 834-2024