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Introduction The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7?days of symptom onset for COVID-19 if tested within 1?h of specimen collection. Gap statement Clinical data on t...
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Introduction The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7?days of symptom onset for COVID-19 if tested within 1?h of specimen collection. Gap statement Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size. Aim In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing. Methodology Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene. Results In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95?% confidence intervals was 89.1?% (82.0–94.1%) and 91.6?% (85.1–95.9%), respectively. When analysing individuals with symptom duration ≤7?days and who had the ID NOW performed within 1?h ( n =62), ID NOW PPA increased to 98.2?%. Conclusion Results from the ID NOW were reliable, especially when adhering to the manufacturer’s recommendations for testing.
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An ultra-sensitive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antigen assay (S-PLEX, MesoScale Diagnostics) was evaluated in 250 retrospective and 200 prospective upper respiratory specimens. In samp...
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An ultra-sensitive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antigen assay (S-PLEX, MesoScale Diagnostics) was evaluated in 250 retrospective and 200 prospective upper respiratory specimens. In samples with cycle threshold <35, there was 95%-98% positive and 93%-96% negative percent agreement with reverse transcription-polymerase chain reaction. S-PLEX may provide a high-throughput alternative to nucleic acid-based testing for coronavirus disease 2019 (COVID-19) diagnosis.
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Background Vaccine effectiveness against COVID-19 needs to be assessed in diverse real-world population settings. Methods A cohort study of 805,741 residents in Skane county, Southern Sweden, aged 18-64 years, of whom 26,587 recei...
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Background Vaccine effectiveness against COVID-19 needs to be assessed in diverse real-world population settings. Methods A cohort study of 805,741 residents in Skane county, Southern Sweden, aged 18-64 years, of whom 26,587 received at least one dose of the BNT162b2 vaccine. Incidence rates of COVID-19 were estimated in sex- and age-adjusted analysis and stratified in two-week periods with substantial community spread of the disease. Results The estimated vaccine effectiveness in preventing infection >= 7 days after second dose was 86% (95% CI 72-94%) but only 42% (95% CI 14-63%) >= 14 days after a single dose. No difference in vaccine effectiveness was observed between females and males. Having a prior positive test was associated with 91% (95% CI 85-94%) effectiveness against new infection among the unvaccinated. Conclusion A satisfactory effectiveness of BNT162b2 after the second dose was suggested, but with possibly substantially lower effect before the second dose.
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Switzerland is among the countries with the highest number of coronavirus disease-2019 (COVID-19) cases per capita in the world. There are likely many people with undetected SARS-CoV-2 infection because testing efforts are current...
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Switzerland is among the countries with the highest number of coronavirus disease-2019 (COVID-19) cases per capita in the world. There are likely many people with undetected SARS-CoV-2 infection because testing efforts are currently not detecting all infected people, including some with clinical disease compatible with COVID-19. Testing on its own will not stop the spread of SARS-CoV-2. Testing is part of a strategy. The World Health Organization recommends a combination of measures: rapid diagnosis and immediate isolation of cases, rigorous tracking and precautionary self-isolation of close contacts. In this article, we explain why the testing strategy in Switzerland should be strengthened urgently, as a core component of a combination approach to control COVID-19.
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Background. Identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections during peripartum hospitalizations is important to guide care, implement prevention measures, and understand infection burden. Methods...
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Background. Identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections during peripartum hospitalizations is important to guide care, implement prevention measures, and understand infection burden. Methods. This cross-sectional analysis used electronic health record data from hospitalizations during which pregnancies ended (peripartum hospitalizations) among a cohort of pregnant persons at 3 US integrated healthcare networks (sites 1-3). Maternal demographic, medical encounter, SARS-CoV-2 testing, and pregnancy and neonatal outcome information was extracted for persons with estimated delivery and pregnancy end dates during March 2020-February 2021 and >=1 antenatal care record. Site-stratified multivariable logistic regression was used to identify factors associated with testing and compare pregnancy and neonatal outcomes among persons tested.
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Background: It is not definitively known if persons with HIV (PWH) are more likely to be SARS-CoV-2 tested or test positive than persons without HIV (PWoH). We describe SARS-CoV-2 testing and positivity in 6 large geographically a...
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Background: It is not definitively known if persons with HIV (PWH) are more likely to be SARS-CoV-2 tested or test positive than persons without HIV (PWoH). We describe SARS-CoV-2 testing and positivity in 6 large geographically and demographically diverse cohorts of PWH and PWoH in the United States. Setting: The Corona Infectious Virus Epidemiology Team comprises 5 clinical cohorts within a health system (Kaiser Permanente Northern California, Oakland, CA; Kaiser Permanente Mid-Atlantic States, Rockville, MD; University of North Carolina Health, Chapel Hill, NC; Vanderbilt University Medical Center, Nashville, TN; and Veterans Aging Cohort Study) and 1 interval cohort (Multicenter AIDS Cohort Study/Women's Interagency HIV Study Combined Cohort Study). Methods: We calculated the proportion of patients SARS-CoV-2 tested and the test positivity proportion by HIV status from March 1 to December 31, 2020. Results: The cohorts ranged in size from 1675 to 31,304 PWH and 1430 to 3,742,604 PWoH. The proportion of PWH who were tested for SARS-CoV-2 (19.6%-40.5% across sites) was significantly higher than PWoH (14.8%-29.4%) in the clinical cohorts. However, among those tested, the proportion of patients with positive SARS-CoV-2 tests was comparable by HIV status; the difference in proportion of SARS-CoV-2 positivity ranged from 4.7% lower to 1.4% higher. Conclusions: Although PWH had higher testing proportions compared with PWoH, we did not find evidence of increased positivity in 6 large, diverse populations across the United States. Ongoing monitoring of testing, positivity, and COVID-19-related outcomes in PWH are needed, given availability, response, and durability of COVID-19 vaccines; emergence of SARS-CoV-2 variants; and latest therapeutic options.
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SARS-CoV-2 is a newly-discovered positive-sense RNA virus, the cause of coronavirus disease 2019 (COVID-19) currently spreading worldwide. The SARS-CoV-2 S glycoprotein is considered a main target for neutralizing antibodies. In o...
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SARS-CoV-2 is a newly-discovered positive-sense RNA virus, the cause of coronavirus disease 2019 (COVID-19) currently spreading worldwide. The SARS-CoV-2 S glycoprotein is considered a main target for neutralizing antibodies. In order to better understand the kinetics of the antibody response, we evaluated the relation between two consecutive antibody titers determined over an average period of four months. A total of 628 subjects were included in the study. A significant reduction of the antibody titers over time was found: Ab Titer 1: 8.1 Arbitrary Units (AU)/mL (IQR: 4.8-29.3); Ab Titer 2: 6.2 AU/mL (IQR: 0-28.5); p<0.0001. A Receiver Operator Characteristic curve analysis showed an Area Under the Curve (AUC) of 0.973 (95% CI: 0.962-0.984; p<0.0001) with an Ab titer 1 threshold of 110 AU/mL to predict an Ab Titer 2 >= 50 AU/mL with 100% specificity. Likewise, an AUC of 0.952 (95% CI: 0.930-0.974; p<0.0001) with an Ab titer 1 threshold of 185 AU/mL was found to predict an Ab Titer 2 >= 100 AU/mL. This study showed that the SARS-CoV-2 S1/S2 IgG median titer declined over an average period of four months and that the first IgG determination thresholds found can help predict IgG values after the same interval.
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Objective To determine the diagnostic yield of repeat testing for SARS-CoV-2. Methods A retrospective analysis was performed of all SARS-CoV-2 test results within the UCLA Health System between March 9th and April 29th, 2020. All ...
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Objective To determine the diagnostic yield of repeat testing for SARS-CoV-2. Methods A retrospective analysis was performed of all SARS-CoV-2 test results within the UCLA Health System between March 9th and April 29th, 2020. All patients with repeat test results were identified, and those with discordant results were reviewed. Results Between March 9th and April 29th, there were 10,165 SARS-CoV-2 test results, of which 630 (6.2%) were positive. Among the 904 patients with repeat test results, 808 (89.4%) were initially negative, and 96 (10.6%) were initially positive. Among the 808 patients with an initial negative test, 15 (1.9%) subsequently tested positive. Eleven cases with an initial negative SARS-CoV-2 test and without a known prior positive SARS-CoV-2 test were reviewed; 6 were employed as healthcare workers, and 10 were positive on the second test. Conclusions We found a low diagnostic yield of repeat testing for SARS-CoV-2 in our health system. Repeat testing might prove useful in certain clinical scenarios, such as in healthcare workers, when symptoms develop after a negative test, and in hospitalized patients with a high clinical suspicion of COVID-19.
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