Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
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Respiratory tract infections are a common cause of visits to emergency departments and outpatient settings. Infections with influenza viruses A and B in particular, are responsible for significant morbidity and mortality in both pediatric and adult populations worldwide. ⋯ In the United States, several of these new tests are approved by the Food and Drug Administration as CLIA-waived tests. In this report, we review the data on the analytical and clinical performance of RIDTs and CLIA-waived molecular tests, present and discuss potential key challenges and opportunities for implementation of CLIA-waived molecular tests at or near point of care in the emergency departments and outpatient settings.
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The Influenza-like Illness Surveillance Network (ILINet) can indicate the presence of novel, widespread community pathogens. Comparing week-to-week reported influenza-like illness percentages may identify the time of year a novel pathogen is introduced. However, changes in health-seeking behavior during the COVID-19 pandemic call in to question the reliability of 2019-2020 ILINet data as a comparison to prior years, potentially rendering this system less reliable as a novel pathogen surveillance tool. Corroboration of trends seen in the 2019-2020 ILINet data lends confidence to the validity of those trends. This study compares predicted versus reported influenza and influenza-like illnesses in vaccinated adults as a surrogate measure of novel pathogen surveillance. ⋯ Flu and flu-like illness in this sample of flu-vaccinated U.S. adults is significantly higher than predicted, consistent with substantially higher ILI's in 2019-20 compared to ILI's from 2018-19, suggesting that the ILI values reported during the COVID-19 pandemic may be appropriate for comparison to prior years.
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The clinical significance of high crossing threshold (Ct) detection of SARS-CoV-2 by RT-PCR is inadequately defined. In the course of universal admission screening with the Cepheid Xpert Xpress SARS-CoV-2 assay at our institution, we observed that 3.9 % (44/1123) of SARS-CoV-2 positive results were negative for the envelope (E) gene target but positive for the nucleocapsid (N2) target. The overall SARS-CoV-2 positivity rate during the three-month study period was 15.4 % (1123/7285), spanning April-June 2020. ⋯ Critically, E-negative, N2-positive results were observed in 8 symptomatic patients with a new diagnosis of COVID-19. Thus, though concerns remain about extended SARS-CoV-2 RT-PCR positivity in some patients, the ability of clinical laboratories to detect patients with high Ct values (including E-negative, N2-positive results) is vital for retaining maximal sensitivity for diagnostic purposes. Our data show that a finding of E-positive, N2-negative SARS-CoV-2 should not be used to rule out the presence of subclinical infection.
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Molecular detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is key in the diagnosis of coronavirus disease 2019 (COVID-19) and has been widely used for followup of cases as a proxy for contagiousness. The persistence of SARS-CoV-2 RNA shedding in the context of clinical features and comorbidities is understudied. ⋯ The cumulative CVS rate at 3 weeks from symptom-onset is 44 % in our entire cohort. The findings of our study highlight the low yield of repeating a SARS-CoV-2 NP PCR test within 21 days of a laboratoryconfirmed COVID-19 diagnosis.
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Comparative Study
Diabetic patients with COVID-19 infection are at higher risk of ICU admission and poor short-term outcome.
The prognostic significance of diabetes mellitus (DM) in patients with coronavirus 2019 disease (COVID-19) remains unknown. ⋯ Diabetic patients with COVID-19 patients are at higher risk of ICU admission and show an higher mortality risk.