Accurate and rapid molecular diagnosis of COVID-19 is a crucial step to tackle the ongoing pandemic. The primary objective of this study was to estimate the real-world performance of the novel RT-PCR STANDARD M10 SARS-CoV-2 assay in a large number of nasopharyngeal (NP) specimens eluted in universal transport medium. The secondary objective was to evaluate the compatibility of this kit in testing NP samples eluted in an inactivated transport medium (essential for point-of-care testing) and lower respiratory tract (LRT) specimens, which are commonly collected in critical care. A total of 591 samples were analyzed. Compared with the standard extraction-based RT-PCR Allplex 2019-nCoV (time-to-result of 270 min), the sensitivities of the STANDARD M10 were 100% (95% CI: 98.1–100%), 95.5% (95% CI: 91.7–97.6%), and 99.5% (95% CI: 97.2–99.9%) for ≥1 gene, the ORF1ab gene, and the E gene, respectively, while the specificity was 100% (95% CI: 98.7–100%). The diagnostic accuracy was 100% in testing both NP samples eluted in an inactivated transport medium and LRT specimens. STANDARD M10 reliably detects SARS-CoV-2 in 60 min, may be used as a POC tool, and is suitable for testing LRT specimens in the critical care setting.
Certain professional categories are at a high occupational exposure to COVID-19. The aim of this survey was to quantify the seroprevalence of SARS-CoV-2 among police officers in Italy and identify its correlates. In this cross-sectional study, a nationally representative sample of State police employees was tested for IgG and IgM before the start of the National vaccination campaign. A total of 10,535 subjects (approximately 10% of the total workforce) participated in the study. The overall seroprevalence was 4.8% (95% CI: 4.4–5.3%). However, seropositivity was unevenly distributed across the country with a clear (p < 0.001) North–South gradient. In particular, the seroprevalence was 5.6 times higher in northern regions than in southern regions (9.0% vs. 1.6%). Most (71.2%) seropositive subjects reported having no recent symptoms potentially attributable to SARS-CoV-2 infection. Previous dysosmia, dysgeusia, and influenza-like illness symptoms were positive predictors of being seropositive. However, the prognostic value of dysosmia depended (p < 0.05) on both sex and prior influenza-like illness. The baseline seroprevalence of SARS-CoV-2 in police employees is considerable. A significant risk of occupational exposure, frequent asymptomatic cases and the progressive waning of neutralizing antibodies suggest that the police workers should be considered among the job categories prioritized for the booster COVID-19 vaccine dose.
Highly accurate lateral flow immunochromatographic tests (LFTs) are an important public health tool to tackle the ongoing COVID-19 pandemic. The aim of this study was to assess the comparative diagnostic performance of the novel ND COVID-19 LFT under real-world conditions. A total of 400 nasopharyngeal swab specimens with a wide range of viral loads were tested in both reverse-transcription polymerase chain reaction and ND LFT. The overall sensitivity and specificity were 85% (95% CI: 76.7–90.7%) and 100% (95% CI: 98.7–100%), respectively. There was a clear association between the false-negative rate and sample viral load: the sensitivity parameters for specimens with cycle threshold values of <25 (>3.95 × 106 copies/mL) and ≥30 (≤1.29 × 105 copies/mL) were 100% and 50%, respectively. The performance was maximized in testing samples with viral loads ≥1.29 × 105 copies/mL. These findings suggest that the ND LFT is sufficiently accurate and useful for mass population screening programs, especially in high-prevalence and resource-constrained settings or during periods when the epidemic curve is rising. Other public health implications were also discussed.
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