Sensibility and Specificity of the VitaPCR™ SARS-CoV-2 Assay for the Rapid Diagnosis of COVID-19 in Older Adults in the Emergency Department

(1) Background: During the COVID-19 pandemic, rapid and reliable diagnostic tools are needed for detecting SARS-CoV-2 infection in urgent cases at admission to the hospital. We aimed to assess the performances of the rapid molecular VitaPCR™ test (Menarini Diagnostics) in a sample of older adults ad...

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Main Authors: Francesco Piacenza, Antonio Cherubini, Roberta Galeazzi, Maurizio Cardelli, Robertina Giacconi, Elisa Pierpaoli, Francesca Marchegiani, Fiorella Marcheselli, Rina Recchioni, Tiziana Casoli, Elisabetta Farnocchia, Beatrice Bartozzi, Belinda Giorgetti, Pierpaolo Stripoli, Anna Rita Bonfigli, Massimiliano Fedecostante, Fabio Salvi, Adolfo Pansoni, Mauro Provinciali, Fabrizia Lattanzio
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Viruses
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Online Access:https://www.mdpi.com/1999-4915/15/1/189
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Summary:(1) Background: During the COVID-19 pandemic, rapid and reliable diagnostic tools are needed for detecting SARS-CoV-2 infection in urgent cases at admission to the hospital. We aimed to assess the performances of the rapid molecular VitaPCR™ test (Menarini Diagnostics) in a sample of older adults admitted to the Emergency Department of two Italian hospitals (2) Methods: The comparison between the rapid VitaPCR™ and the RT-PCR was performed in 1695 samples. Two naso-pharyngeal swab samplings from each individual were obtained and processed using the VitaPCR™ and the RT-PCR for the detection of SARS-CoV-2 (3) Results: VitaPCR™ exhibited good precision (<3% CV) and an almost perfect overall agreement (Cohen’s K = 0.90) with the RT-PCR. The limit of detection of the VitaPCR™ was 4.1 copies/µL. Compared to the RT-PCR, the sensitivity, the specificity, and the positive and negative predictive values of VitaPCR™ were 83.4%, 99.9%, 99.2% and 98.3%, respectively (4) Conclusions: The VitaPCR™ showed similar sensitivity and specificity to other molecular-based rapid tests. This study suggests that the VitaPCR™ can allow the rapid management of patients within the Emergency Department. Nevertheless, it is advisable to obtain a negative result by a RT-PCR assay before admitting a patient to a regular ward.
ISSN:1999-4915