WS/T 807-2022 in English
VALIDPerformance verification of clinical microbial culture, identification and antimicrobial susceptibility testing systems
- Issued on:2022-11-02
- Implemented on:2023-05-01
- File Format:PDF
- Delivery:Via email within 5 business days
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$379.00
本标准规定了临床微生物形态学检查、培养、鉴定、药敏、分子即时检测等系统性能验证的要求。
本标准适用于开展临床微生物检验的医学实验室。
Introduction
Analysis of the core content of the standard
Scope of application and technical framework
This standard is applicable to medical laboratories that conduct clinical microbiological testing, and specifies the performance verification requirements for the entire process from morphological examination to molecular testing.
- Basic verification module: staining method, culture medium evaluation
- System verification module: automated inoculator, blood culture system
- Advanced verification module: MALDI-TOF MS identification, drug sensitivity detection system
Key performance indicator verification requirements
| Test items | Verification indicators | Strain requirements | Acceptable criteria |
|---|---|---|---|
| Gram stain | Compliance rate | 5 strains (positive and negative control) | 100% |
| Blood Culture System | Detection Rate | 5 strains/bottle type (aerobic/anaerobic) | ≥80% |
| MALDI-TOF MS | Accuracy | 30 strains/category | ≥90% |
| Drug Susceptibility System | Classification Consistency (CA) | 30 strains/drug | ≥90% |
Implementation Points and Case Studies
Example of a typical validation scheme (drug susceptibility system)
- Strain selection: including special drug-resistant phenotypes such as MRSA and ESBL-positive strains
- Comparison method: broth dilution method as reference method
- Data collection: record MIC values and S/I/R classification
- Result analysis: calculate VME≤3%, ME≤3%
Case: When a tertiary hospital validated the VITEK 2 system, 30 strains of Pseudomonas aeruginosa (including 8 resistant strains) were used for imipenem, with a CA of 93.3% and an EA of 96.7%, which met the standard requirements.
Technology Evolution and Risk Management
Highlights of Standard Updates
- New requirements for molecular POCT system validation
- Refine the MALDI-TOF MS database validation scheme
- Introduce a risk assessment matrix (Table 1)
Common Risk Control Measures
- False Sensitivity Risk: Add additional tests (such as mecA gene testing)
- Cross-contamination: Regularly verify the sterilization procedure of the automated inoculator
- Software Update: Revalidate the expert system rules when the version changes
Sample only — not a preview of WS/T 807-2022
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