Assuntos
COVID-19/imunologia , Leucemia Linfocítica Crônica de Células B/imunologia , Subpopulações de Linfócitos/imunologia , Vacinação/métodos , Adulto , Tirosina Quinase da Agamaglobulinemia/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Vacina BNT162/administração & dosagem , COVID-19/diagnóstico , COVID-19/prevenção & controle , COVID-19/virologia , Estudos de Casos e Controles , ChAdOx1 nCoV-19/administração & dosagem , Humanos , Imunidade/imunologia , Imunoterapia Adotiva/métodos , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Leucemia Linfocítica Crônica de Células B/virologia , Modelos Logísticos , Subpopulações de Linfócitos/metabolismo , Pessoa de Meia-Idade , SARS-CoV-2/genética , SARS-CoV-2/imunologia , Glicoproteína da Espícula de Coronavírus/imunologiaRESUMO
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.