Asunto(s)
COVID-19/inmunología , Leucemia Linfocítica Crónica de Células B/inmunología , Subgrupos Linfocitarios/inmunología , Vacunación/métodos , Adulto , Agammaglobulinemia Tirosina Quinasa/antagonistas & inhibidores , Anciano , Anciano de 80 o más Años , Vacuna BNT162/administración & dosificación , COVID-19/diagnóstico , COVID-19/prevención & control , COVID-19/virología , Estudios de Casos y Controles , ChAdOx1 nCoV-19/administración & dosificación , Humanos , Inmunidad/inmunología , Inmunoterapia Adoptiva/métodos , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Leucemia Linfocítica Crónica de Células B/virología , Modelos Logísticos , Subgrupos Linfocitarios/metabolismo , Persona de Mediana Edad , SARS-CoV-2/genética , SARS-CoV-2/inmunología , Glicoproteína de la Espiga del Coronavirus/inmunologíaRESUMEN
OBJECTIVES: This study aimed to compare the performance of the NeuMoDx™ SARS-CoV-2 Assay, implemented on the NeuMoDx 96 Molecular System, with that of the ThermoFisher TaqPath™ COVID-19 CE-IVD RT-PCR Kit (reference method). METHODS: Overall, 450 nasopharyngeal swab samples, previously tested using the reference method, were tested by the NeuMoDx Assay, and the clinical sensitivity and specificity of the assay were analyzed. RESULTS: By retrospective statistical analysis of all valid results, the NeuMoDx Assay had a clinical specificity of 100% (95% confidence interval [CI]: 98.65-100.00) and a clinical sensitivity of 98.73% (95% CI: 95.47-99.85). CONCLUSIONS: The NeuMoDx SARS-CoV-2 Assay demonstrated comparable analytical and clinical performance to the ThermoFisher TaqPath COVID-19 CE-IVD RT-PCR Kit. The NeuMoDx 96 Molecular System is well suited for automating medium-throughput routine SARS-CoV-2 testing or as an addition to high-throughput systems to allow fast-tracking for highly urgent clinical samples.