WS 588-2018 in English
VALIDDiagnosis for hand, foot and mouth disease
- Issued on:2018-03-06
- Implemented on:2018-08-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
Price(USD)：
$430.00
$418.00
$418.00
本标准规定了手足口病的诊断依据、诊断原则、诊断和鉴别诊断。
本标准适用于全国各级各类医疗卫生机构及其医务人员对手足口病的诊断。
Introduction
Interpretation of the core content of the standard
| Diagnostic elements | Common type standard | Severe type standard | Critical type standard |
|---|---|---|---|
| Main clinical manifestations | Rash + oral herpes ± fever | Central nervous system symptoms | Respiratory/circulatory failure |
| Laboratory indicators | - | Increased white blood cell count/blood sugar | Multiple organ dysfunction |
| Etiology confirmation | Required to meet: EV-A71/CV-A16 IgM positive or IgG 4-fold increase or nucleic acid positive or virus isolation | ||
Analysis of key technical points
1. Pathogen detection method
The standard specifies four diagnosis methods:
- ELISA to detect specific IgM antibodies (Appendix A)
- Neutralization test to detect IgG antibodies ≥ 4-fold increase
- RT-PCR to detect viral nucleic acid (Appendix B)
- RD/HEp-2 cell virus isolation (Appendix C)
2. Key points for the implementation of clinical typing
Typical case: A 3-year-old child had fever and rash on his hands. Nystagmus developed within 48 hours. Laboratory tests showed a white blood cell count of 12×10⁹/L and a positive EV-A71 nucleic acid test. He should be diagnosed with severe hand, foot and mouth disease.
Standard Evolution and Innovation
Compared with the 2008 version, the 2018 version has the following major updates:
- Added a CV-A16-specific detection method
- Refine the critical severity determination criteria
- Standardize the Ct value determination threshold for nucleic acid detection
Implementation Suggestions
1. Diagnostic process optimization
Recommended hierarchical detection strategy:
- First perform enterovirus universal PCR screening
- Positive specimens are then typed for EV-A71/CV-A16
- Add serological dynamic monitoring for severe cases
2. Key points of quality control
| Detection link | Key control indicators |
|---|---|
| Virus isolation | CPE determination requires double review |
| Nucleic acid detection | Internal standard gene Ct value ≤32 |
| Serological test | Negative control OD value ≤0.1 |
Sample only — not a preview of WS 588-2018
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