Readiness Level of Spanish Labs to Detect Mpox Clade Ib: A Nationwide EQA
To assess the preparedness and diagnostic capacity of Spanish clinical microbiology laboratories to detect the emerging monkeypox virus (MPXV) Clade Ib through a nationwide external quality assessment. A blinded 16‐sample panel (serum and DNA eluates) containing MPXV Clade Ib, Clade II, vaccinia, an...
| Autores: | , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2026 |
| País: | España |
| Institución: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:dnet:docusalut___::92ab4fd4b25536a1c36414256f9d9ef4 |
| Acceso en línea: | https://hdl.handle.net/20.500.13003/27491 |
| Access Level: | acceso abierto |
| Palabra clave: | Humans Laboratories, Clinical Monkeypox virus Mpox (monkeypox) Quality Assurance, Health Care Sensitivity and Specificity Spain Humanos Laboratorios Clínicos Mpox Garantía de la Calidad de Atención de Salud España Clade Ib MPXV PCR external quality assessment |
| Sumario: | To assess the preparedness and diagnostic capacity of Spanish clinical microbiology laboratories to detect the emerging monkeypox virus (MPXV) Clade Ib through a nationwide external quality assessment. A blinded 16‐sample panel (serum and DNA eluates) containing MPXV Clade Ib, Clade II, vaccinia, and negatives was distributed. Of 36 laboratories submitting results, 25 with clade‐level capability were included. Performance versus reference was adjudicated as full, partial, or discordant concordance; species‐level and clade‐specific metrics were estimated, and inter‐laboratory agreement summarized with simple and weighted kappa (Wilson 95% CIs; bootstrap for kappa CIs). Species‐level MPXV detection was consistently strong (mean sensitivity 85%, specificity 95%). Agreement was substantial (simple kappa 0.70; weighted 0.81). For Clade Ib, mean sensitivity was 50% (range: 0%–100%) with high but variable specificity (100%). For clade II, mean sensitivity averaged 70% (25%–100%) and specificity 98% (66.7%–100%). Methodologies varied across centers: 68% used independent extraction plus commercial PCR, 20% mixed commercial extraction with in‐house PCR, and 12% integrated extraction‐PCR platforms. In conclusion, Spanish laboratories maintain good capacity for MPXV species‐level detection, but clade discrimination—particularly for emerging Clade Ib—remains heterogeneous and suboptimal across participating centers. Expanding QC panels to include new clades and updating/validating assays should enhance national readiness for future transmission events. |
|---|