欧洲疾控中心-2024年欧盟_欧洲经济区和欧盟扩大国家沙门氏菌分型的第十四次外部质量评估（英）_76页_2mb

报告摘要

Objective: To assess the performance of National Public Health Reference Laboratories (NPHRLs) in EU/EEA and enlargement countries for serotyping Salmonella and performing molecular-based cluster analysis. This supports surveillance and outbreak detection.
Context: Salmonella causes significant zoonotic disease burden (~77,000 EU cases in 2023). Serotypes like Typhimurium and Enteritidis are common and often associated with outbreaks. Newer methods like WGS are increasingly replacing traditional techniques.

30 countries invited; 29 laboratories participated (≥1 serotyping isolate).
29 laboratories completed serotyping (~55% using traditional phenotyping).
24 laboratories completed the molecular typing part (all used WGS; some also used MLVA).

Serotyping: Involving 12 isolates with carefully selected, challenging serovars (some not S. enterica).
Cluster Analysis: Involving 10 isolates from a simulated monophasic S. Typhimurium outbreak; additional food isolate sequencing tests for WGS participants. PFGE was not used.

High Performance: About half of the participating labs achieved 100% correct serovar reporting (48%), with overall high scores.
Methods: Phenotypic (O/H agglutination) and WGS-predictive methods were used. Combining both methods showed overall performance similar to single methods (not statistically significant).
Challenges: Low performance was linked partly to phenotypic method use (especially for Salmonella non-enterica) and common notation errors. Rare serovars like IIIb:47:k:z35 remained challenging.
Recommendation: Minimum suitability level for cluster analysis is WGS-based. PFGE is discouraged due to inferior resolution and limited use.

Widespread Use: WGS is the dominant technique (~100%).
High Performance: Excellent cluster assignment performance overall (88% correct assignment). Multiple methods and approaches did not impact performance.
WGS Quality: High average quality of WGS data submitted. Good coverage and contamination control were achieved by many labs.
Challenges: Insufficient quality assessment for datasets was a concern for some labs. Strengths were maintained through higher coverage labs.
Recommendation: WGS is strongly recommended (as minimum for outbreaks). MLVA is suitable for specific serovars (Typhimurium, Enteritidis) but transition to WGS is desirable as MLVA usage decreases. PFGE is obsolete for international collaboration.

Documentation: All responding labs (31%) used results for accreditation/licensure.
Action Taken: 78% of responding labs had all analytical results conform; 22% took corrective actions (e.g., adjusting SOPs) demonstrating value.
Suggestions: Guidance on cluster cut-offs and inclusion of more rare serovars for EQAs were mentioned.

Laboratories generally perform well for serotyping (S. Typhimurium, Enteritidis, Infantis are consistently well-typed).
High performance in molecular typing (WGS, SNP) supports timely detection, especially of zoonotic diseases like salmonellosis.
The valuable trend is increasing capability with molecular methods, improving multinational outbreak detection potential.

ECDC/FWD-Net: St Continue ECDC-FWDNet support for WGS transition and harmonization. Provide education on cut-off selection.
Countries: Ensure continuous participation in EQAs to monitor performance. Submit high-quality WGS data in real-time.
Laboratories: Participate in ECDC/FWDNet EQAs, utilize feedback for improvement, and maintain robust methods for both serotyping and cluster analysis.

展开完整摘要