AimsTo date, reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs is the ‘gold standard’ approach for the diagnosis of COVID-19. The need to develop easy to use, rapid, robust and with minimal hands-on time approaches are warranted. In this setting, the Idylla SARS-CoV-2 Test may be a valuable option. The aim of our study is to evaluate the analytical and clinical performance of this assay on previously tested SARS-CoV-2 people by conventional RT-PCR based approach in different settings, including initial diagnosis and clinical follow-up.MethodsTo evaluate the sensitivity and specificity of the Idylla SARS-CoV-2 Test, we retrieved 55 nasopharyngeal swabs, previously analysed by a fully validated assay, from symptomatic patients or from people who have been in close contact with COVID-19 positive cases. Discordant or high discrepant cases were further analysed by a third technique. In addition, a second subset of 14 nasopharyngeal swab samples with uncertain results (cycle threshold between 37 and 40), by using the fully validated assay, from patients with viral infection beyond day 21, were retrieved.ResultsOverall, Idylla showed a sensitivity of 93.9% and a specificity of 100.0%. In addition, in the additional 14 nasopharyngeal swab samples, only five (35.7%) featured a positive result by the Idylla SARS-CoV-2 Test.ConclusionsWe demonstrated that the Idylla SARS-CoV-2 Test may represent a valid, fast, highly sensitive and specific RT-PCR test for the identification of SARS-CoV-2 infection.
Background: Healthcare workers were at high risk of contracting COVID-19 during the pandemic due to their frontline commitment. This risk was higher than in the general population because they were exposed to the virus both at work and outside the hospital. Healthcare workers suffered from physical and psychological stress, which could lead to mental health problems. Aims: The aim of the study was to evaluate the effectiveness of four proactive interventions implemented to protect workers' health during the COVID-19 pandemic at the “Federico II” University Hospital in Naples, Italy. The study aimed to prevent both clinical and non-clinical risks, such as infections contagion and work-related stress. Methods: A prospective observational study was conducted between April 9 and May 21, 2020, at the “Federico II” University Hospital. Healthcare personnel, who worked during the study period, were subject to four proactive interventions: (I) Classification based on the risk of exposure to SARS-Cov-2; (II) Healthcare surveillance: diagnostic surveillance (nasopharyngeal swabs for SARS-Cov-2, rapid antigen tests and serological for the detection of IgM/IgG antibodies against SARS-Cov-2), clinical and epidemiological surveillance (physical examination and contact tracing), individual psychological support; (III) Contacts-tracing;(IV) Constant training and information. The study analysed the number of positive swabs in healthcare workers and hospitalised patients during the same period, comparing the incidence of cases with international data. Feedback from psychologists and occupational doctors was also collected to evaluate the impact on non-clinical risks. Results: The study found a low correlation between positive swabs in healthcare workers and patients, suggesting that the preventive measures in place were effective. Furthermore, feedback from psychologists and occupational doctors did not report an increase in stress-related sick leaves, thanks to the proactive actions. Conclusions: The considered proactive interventions proved to be useful to protect healthcare workers during the pandemic. The study highlights the importance of a proactive approach instead of a reactive one, and the necessity to contemplate both the protection from biological risks and the psychological support.
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