WS/T 269-2019 in English
VALIDDiagnosis for brucellosis
- Issued on:2019-01-02
- Implemented on:2019-07-01
- File Format:PDF
- Delivery:Via email within 5 business days
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$466.00
Introduction
Core changes in the standard revision
| Dimensions | WS 269-2007 | WS 269-2019 |
|---|---|---|
| Detection technology | Only traditional agglutination test | Five new technologies including colloidal gold immunochromatography (GICA), ELISA, and nucleic acid detection |
| Diagnostic process | Two-stage diagnosis | New clinical diagnosis stage (suspected case + initial screening positive) |
| Biosafety | Undefined classification | BSL-2/3 laboratory requirements clarified according to the list of pathogenic microorganisms |
Analysis of key technology updates
1. Molecular detection technology
Newly added BCSP31-PCR and AMOS-PCR methods:
- BCSP31-PCR: 224bp fragment detects genus-specific genes with a sensitivity of 10^3 CFU/mL
- AMOS-PCR: Can distinguish between bovine (498bp), ovine (731bp), porcine (285bp) and other bacterial species
2. Serological testing optimization
| Method | Detection window period | Clinical application value |
|---|---|---|
| GICA | Acute phase 3-7 days | Rapid screening at the grassroots level (results in 15 minutes) |
| IgG-ELISA | 2 weeks after infection | Quantitative analysis (＞12U/mL is positive) |
Implementation recommendations
- Diagnostic pathway: Suspected case → GICA/RBT initial screening → ELISA/SAT confirmation → PCR/culture identification
- Biosafety: Live bacteria operations require a BSL-3 laboratory, serological testing can be performed in a BSL-2 laboratory
- Quality Control: Each batch must include positive and negative controls, and SAT tests require turbidimetric tubes.
Background of Standard Development
The 2019 standard primarily addresses emerging characteristics of brucellosis in my country: annual reported cases exceeding 50,000, and a rising prevalence of Brucella suis (B. suis) infections reaching 12%. The revision process took three years and was jointly validated by eight CDCs. Technological advancements have increased diagnostic sensitivity from 82% to 95%.
Sample only — not a preview of WS/T 269-2019
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