Corpus overview


MeSH Disease

Human Phenotype

Fever (35)

Pneumonia (24)

Cough (16)

Anosmia (11)

Falls (7)


    displaying 1 - 10 records in total 685
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    Population-based prevalence SERO surveys during the COVID-19 pandemic: a systematic review

    Authors: Vinicius Bonetti Franceschi Jr.; Andressa Schneiders Santos Jr.; Andressa Barreto Glaeser Jr.; Janini Cristina Paiz Jr.; Gabriel Dickin Caldana Jr.; Carem Luana Machado Lessa Jr.; Amanda de Menezes Mayer Jr.; Julia Goncalves Kuchle Jr.; Paulo Ricardo Gazzola Zen Sr.; Alvaro Vigo Sr.; Ana Trindade Winck Sr.; Liane Nanci Rotta Sr.; Claudia Elizabeth Thompson Sr.; Andres F. Henao-Martinez; Leland Shapiro

    doi:10.1101/2020.10.20.20216259 Date: 2020-10-22 Source: medRxiv

    Population-based prevalence SERO surveys of COVID-19 contribute to establish the burden and epidemiology of infection MESHD, the role of asymptomatic TRANS and mild infections MESHD in transmission TRANS, and allow more precise decisions about reopen policies. We performed a systematic review to evaluate qualitative aspects of these studies, their reliability, and biases. The available data described 37 surveys from 19 countries, mostly from Europe and America and using antibody testing SERO. They reached highly heterogeneous sample sizes and prevalence SERO estimates. Disproportional prevalence SERO was observed in minority communities. Important risk of bias was detected in four domains: sample size, data analysis with sufficient coverage, measurements in standard way, and response rate. The correspondence analysis showed few consistent patterns for high risk of bias. Intermediate risk of bias was related to American and European studies, blood SERO samples and prevalence SERO >1%. Low risk of bias was related to Asian studies, RT-PCR tests and prevalence SERO <1%.

    Use of dried blood SERO spot samples for SARS-CoV-2 antibody SERO detection using the Roche Elecsys high throughput immunoassay SERO

    Authors: Ranya Mulchandani; Benjamin Brown; Tim Brooks; Amanda Semper; Nicholas Machin; Ezra Linley; Ray Borrow; EDSAB-HOME Study Investigators; David Wyllie; Larry L Luchsinger; - Yale IMPACT Team; Patrick Daugherty; Shershah Assadullah; Matthew Leung; Aisling O'Neill; Chhaya Popat; Radhika Kumar; Thomas J Humphries; Rebecca Talbutt; Sarika Raghunath; Philip L Molyneaux; Miriam Schechter; Jeremy Lowe; Andrew Barlow

    doi:10.1101/2020.10.19.20215228 Date: 2020-10-21 Source: medRxiv

    Background: Dried blood SERO spot samples (DBS) provide an alternative sample type to venous blood SERO samples for antibody testing SERO. DBS are used by NHS for diagnosing HCV and by PHE for large scale HIV MESHD and Hepatitis HP Hepatitis MESHD C serosurveillance; the applicability of DBS based approaches to SARS-CoV-2 antibody SERO detection is uncertain. Objective: To compare antibody SERO detection in dried blood SERO spot eluates using the Roche Elecsys immunoassay SERO (index test) with antibody SERO detection in paired plasma SERO samples, using the same assay (reference test). Setting: One Police and one Fire & Rescue facility in England. Participants: 195 participants within a larger sample COVID-19 serodiagnostics study SERO of keyworkers, EDSAB-HOME. Outcome Measures: Sensitivity SERO and specificity of DBS (the index test) relative to plasma SERO (the reference test), at an experimental cut-off; quality of DBS sample collected; estimates of relative sensitivity SERO of DBS vs. plasma SERO immunoassay SERO in a larger population. Results: 18/195 (9.2%) participants tested positive using plasma SERO samples. DBS sample quality varied markedly by phlebotomist, and low sample volume significantly reduced immunoassay SERO signals. Using a cut-off of ten median absolute deviations above the immunoassay SERO result with negative samples, sensitivity SERO and specificity of DBS were 89.0% (95% CI 67.2, 96.9%) and 100.0% (95% CI 97.9, 100%) respectively compared with using plasma SERO. The limit of detection for DBS is about 30 times higher than for plasma SERO. Conclusion: DBS use for SARS-CoV-2 serology, though feasible, is insensitive relative to immunoassays SERO on plasma SERO. Sample quality impacts on assay performance SERO. Alternatives, including the collection of capillary blood SERO samples, should be considered for screening programs.

    Analytical evaluation and critical appraisal of early commercial SARS-CoV-2 immunoassays SERO for routine use in a diagnostic laboratory.

    Authors: Amanda Cramer; Nigel Goodman; Timothy Cross; Vanya A Gant; Magdalena Dziadzio; Izabella Bezerra; Raiana Barbosa; Tais Hanae Kasai Brunswick; Glauber Monteiro Dias; Aurora Issa; Antonio Carlos Campos de Carvalho; Louise Perrin de Facci; Marie-Noelle Ungeheuer; Lucie Leon; Yvonnick Guillois; Laurent Filleul; Pierre Charneau; Daniel Levy-Bruhl; Sylvie van der Werf; Harold Noel; Eran Friedler; Yael Gilboa; Sara Sabach; Yuval Alfiya; Uta Cheruti; Nadav Davidovitch; Natalya Bilenko; Jacob Moran-Gilad; Yakir Berchenko; Itay Bar-Or; Ariel Kushmaro; Timothy Spector; Claire J Steves

    doi:10.1101/2020.10.20.20215970 Date: 2020-10-21 Source: medRxiv

    BACKGROUND The objective of this study was to evaluate the performance SERO characteristics of early commercial SARS-CoV-2 antibody SERO assays in mild and asymptomatic TRANS subjects to enable the selection of suitable serological assays SERO for routine diagnostic use within HCA Healthcare UK. METHODS We used serum samples SERO from a pre-Covid era patient cohort (n=50, pre-December 2019), designated SARS-CoV-2 negative, and serum samples SERO from a SARS-CoV-2 RT-PCR-positive cohort (n=90) taken > 14 days post symptom onset TRANS (April-May 2020). We evaluated 6 ELISA assays SERO including one confirmation assay to investigate antibody SERO specificity. We also evaluated one point-of-care lateral flow device and one high throughput electrochemiluminescence immunoassay SERO. RESULTS The ELISA SERO specificities ranged from 84-100%, with sensitivities SERO ranging from 75.3-90.0%. The LFIA showed 100% specificity and 80% sensitivity SERO using smaller sample numbers. The Roche CLIA immunoassay SERO showed 100% specificity and 90.7% sensitivity SERO. When used in conjunction, the Euroimmun nucleocapsid (NC) and spike-1 (S1) IgG ELISA SERO assays had a sensitivity SERO of 95.6%. The confirmation IgG assay showed 92.6% of samples tested contained both NC and S1 antibodies SERO, 32.7% had NC, S1 and S2 and 0% had either S1 or S2 only. CONCLUSIONS These first generation assays were not calibrated against reference material and the results are reported qualitatively. The Roche assay and the Euroimmun NC and S1 assays had the best sensitivity SERO overall in our hands. Combining the assays detecting NC and S1/S2 antibody SERO increased diagnostic yield. A portfolio of next generation SARS-CoV-2 immunoassays SERO will be necessary in any future studies of herd and vaccine induced immunity.


    Authors: Valeria Oliveira Silva; Elaine Lopes de Oliveira; Marcia Jorge Castejon; Rosemeire Yamashiro; Cintia Mayumi Ahagon; Giselle Ibette Lopez-Lopes; Edilene Peres Real da Silveira; Marisa Ailin Hong; Maria do Carmo Timenetsky; Carmem aparecida de Freitas Oliveira; Luis Fernando de Macedo Brigido; Satish Lakkakula; Oren Miron; Ehud Rinott; Ricardo Gilead Baibich; Iris Bigler; Matan Malul; Rotem Rishti; Asher Brenner; Yair E. Lewis; Eran Friedler; Yael Gilboa; Sara Sabach; Yuval Alfiya; Uta Cheruti; Nadav Davidovitch; Natalya Bilenko; Jacob Moran-Gilad; Yakir Berchenko; Itay Bar-Or; Ariel Kushmaro; Timothy Spector; Claire J Steves

    doi:10.1101/2020.10.19.20213421 Date: 2020-10-21 Source: medRxiv

    Background: Covid-19 Serology may document exposure and perhaps protection to the virus, and serological test SERO may help understand epidemic dynamics. To evaluate previous exposure to the virus we estimated the prevalence SERO of antibodies SERO against-SARS-CoV-2 among HPs in Adolfo Lutz Institute, State of Sao Paulo, Brazil. Methods: This study was performed among professionals of Adolfo Lutz Institute in Sao Paulo, Brazil and some administrative areas of the Secretary of Health that shares common areas with the institute. We used a lateral flow immunoassay SERO ( rapid test SERO) to detect IgG and IgM for SARS-CoV-2; positive samples were further evaluated using Roche Electrochemiluminescence assay and SARS-CoV-2 RNA by real time reverse transcriptase polymerase chain reaction (RT-PCR) was also offered to participants. Results: A total of 406 HPs participated. Thirty five (8.6%) tested positive on rapid test SERO and 32 these rapid test SERO seropositive cases were confirmed TRANS by ECLIA.. 43 HPs had SARS-CoV-2 RNA detected at a median of 33 days, and the three cases not reactive at Roche ECLIA had a previous positive RNA. Outsourced professionals (34% seropositive), males TRANS (15%) workers referring COVID-19 patients at home (22%) and those living farther form the institute tended to have higher prevalence SERO of seropositivity, but in multivariable logistic analysis only outsourced workers and those with COVID patients at home remained independently associated to seropositivity. We observed no relation of seropositivity to COVID samples handling. Presence of at least one symptom was common but some clinical manifestations as anosmia HP anosmia MESHD/dysgeusia. Fatigue HP, cough HP cough MESHD and fever HP fever MESHD were associated to seropositivity. Conclusions: We documented a relatively high (8.6%) of anti-SARS-CoV-2 serological reactivity in this population, with higher rates among outsourced workers and those with referring cohabitation with COVID-19 patients. COVID samples handling was not related to increased seropositivity. Some symptoms how strong association to COVID-19 serology and may be used in scoring tools for screening or diagnosis in resort limited settings.

    From multiplex serology to serolomics: A novel approach to the antibody SERO response against the SARS-CoV-2 proteome

    Authors: Julia Butt; Rajagopal Murugan; Theresa Hippchen; Sylvia Olberg; Monique van Straaten; Hedda Wardemann; Erec Stebbins; Hans-Georg Kraeusslich; Ralf Bartenschlager; Hermann Brenner; Vibor Laketa; Ben Schoettker; Barbara Mueller; Uta Merle; Tim Waterboer; James Watmough; Jude Dzevela Kong; Iain Moyles; Huaiping Zhu

    doi:10.1101/2020.10.19.20214916 Date: 2020-10-21 Source: medRxiv

    Background: The emerging SARS-CoV-2 pandemic entails an urgent need for specific and sensitive high-throughput serological assays SERO to assess SARS-CoV-2 epidemiology. We therefore aimed at developing a fluorescent-bead based SARS-CoV-2 multiplex serology assay for detection of antibody SERO responses to the SARS-CoV-2 proteome. Methods: Proteins of the SARS-CoV-2 proteome and protein N of SARS-CoV-1 and common cold Coronaviruses (ccCoVs) were recombinantly expressed in E. coli or HEK293 cells. Assay performance SERO was assessed in a Covid-19 case cohort (n=48 hospitalized patients from Heidelberg) as well as n=85 age TRANS- and sex-matched pre-pandemic controls from the ESTHER study. Assay validation included comparison with home-made immunofluorescence and commercial Enzyme-linked immunosorbent ( ELISA) assays SERO. Results: A sensitivity SERO of 100% (95% CI: 86%-100%) was achieved in Covid-19 patients 14 days post symptom onset TRANS with dual sero-positivity to SARS-CoV-2 N MESHD and the receptor-binding domain of the spike protein. The specificity obtained with this algorithm was 100% (95% CI: 96%-100%). Antibody SERO responses to ccCoVs N were abundantly high and did not correlate with those to SARS-CoV-2 N MESHD. Inclusion of additional SARS-CoV-2 proteins as well as separate assessment of immunoglobulin (Ig) classes M, A, and G allowed for explorative analyses regarding disease progression and course of antibody SERO response. Conclusion: This newly developed SARS-CoV-2 multiplex serology assay achieved high sensitivity SERO and specificity to determine SARS-CoV-2 sero-positivity. Its high throughput ability allows epidemiologic SARS-CoV-2 research in large population-based studies. Inclusion of additional pathogens into the panel as well as separate assessment of Ig isotypes will furthermore allow addressing research questions beyond SARS-CoV-2 sero- prevalence SERO.

    Prevalence SERO of antibodies to SARS-CoV-2 SERO in healthy blood SERO donors in New York

    Authors: Kathy Kamath; Elisabeth Baum-Jones; Gregory Jordan; Winston Haynes; Rebecca Waitz; John Shon; Steve Kujawa; Lyn Fitzgibbons; Debra Kessler; Larry L Luchsinger; - Yale IMPACT Team; Patrick Daugherty; Shershah Assadullah; Matthew Leung; Aisling O'Neill; Chhaya Popat; Radhika Kumar; Thomas J Humphries; Rebecca Talbutt; Sarika Raghunath; Philip L Molyneaux; Miriam Schechter; Jeremy Lowe; Andrew Barlow

    doi:10.1101/2020.10.19.20215368 Date: 2020-10-21 Source: medRxiv

    ABSTRACT Despite the high level of morbidity and mortality worldwide, there is increasing evidence for asymptomatic TRANS carriers TRANS of the novel coronavirus SARS-CoV-2. We analyzed blood SERO specimens from 1,559 healthy blood SERO donors, collected in the greater New York metropolitan area between the months of March and July 2020 for antibodies to SARS-CoV-2 SERO virus. Using our proprietary technology, SERA ( Serum SERO Epitope Repertoire Analysis), we observed a significant increase in SARS-CoV-2 seropositivity rates over the four-month period, from 0% [95% CI: 0 - 1.5%] (March) to 11.6% [6.0 - 21.2%] (July). Follow-up ELISA SERO tests using S1 and nucleocapsid viral proteins confirmed most of these results. Our findings are consistent with seroprevalence SERO studies within the region and with reports that SARS-COV-2 infections MESHD can be asymptomatic TRANS or cause only mild symptoms. IMPORTANCE The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, has caused vast morbidity and mortality worldwide, yet several studies indicate that there may be a significant number of infected people MESHD who are asymptomatic TRANS or exhibit mild symptoms. In this study, samples were collected from healthy blood SERO donors in a region of rapidly increasing disease burden (New York metropolitan area) and we hypothesized that a subset would be seropositive to SARS-CoV-2. People who experienced mild or no symptoms during SARS-CoV-2 infection MESHD may represent a source for convalescent plasma SERO donors.

    Prevalence SERO of SARS-CoV-2 IgG antibodies SERO in a population from Veracruz (Southeastern Mexico).

    Authors: Jose Maria Remes-Troche; Antonio Ramos-de-la-Medina; Marisol Manriquez-Reyes; Laura Martinez-Perez Maldonado; Maria Antonieta Solis-Gonzalez; Karina Hernandez-Flores; Hector Vivanco-Cid; Graham Cooke; Timothy B Hallett; Katharina D Hauck; Peter J White; Mark R Thursz; Shevanthi Nayagam; Brendan Flannery; Ricardo Gilead Baibich; Iris Bigler; Matan Malul; Rotem Rishti; Asher Brenner; Yair E. Lewis; Eran Friedler; Yael Gilboa; Sara Sabach; Yuval Alfiya; Uta Cheruti; Nadav Davidovitch; Natalya Bilenko; Jacob Moran-Gilad; Yakir Berchenko; Itay Bar-Or; Ariel Kushmaro; Timothy Spector; Claire J Steves

    doi:10.1101/2020.10.19.20215558 Date: 2020-10-21 Source: medRxiv

    Introduction/Aim: Recent studies have shown that seroprevalence SERO is quite variable depending on the country, the population and the time of the pandemic in which the serological tests SERO are performed. Here, we investigated the prevalence SERO of IgG antibodies SERO against SARS-CoV-2 in a population living in Veracruz City, Mexico. Methods: From of June 1 to July 31, 2020, the consecutive adult TRANS patients that attended 2 ambulatory diagnostic private practice centers for testing were included. Samples were run on the Abbott Architect instrument using the commercial Abbott SARS-CoV-2 IgG assay. The main outcome was seroprevalence SERO. Demographics, previous infection MESHD to SARS-CoV-2 (according to a previous positive polymerase-chain reaction nasopharyngeal swab), self-suspicious of virus of infection MESHD (according to have in the previous 4 weeks either fever HP fever MESHD, headache HP headache MESHD, respiratory symptoms but not a confirmatory PCR) or no having symptoms were also evaluated. Results: A total of 2174 subjects were tested, included 53.6% women (mean age TRANS 41.8, range 18-98 years). One thousand and forty-one (52.5%) subjects were asymptomatic TRANS, 722 (33.2%) had suspicious of infection MESHD and 311 (14.3%) had previous infection MESHD. Overall, 642 of 2174 (29.5% [95% CI 27.59%-31.47%]) of our population were seropositive. Seropositivity among groups was 21.3% in asymptomatic TRANS, 23.4% in self-suspicious patients and 73.9% in previous infection MESHD patients. Conclusions: We found one of the highest seroprevalences SERO reported for SARS-CoV-2 worldwide in asymptomatic TRANS subjects (21.3%) as well in subjects with self-suspicious of COVID-19 (23.4%). The number of infected subjects in our population is not encouraging and it should be interpreted with caution.

    Prevalence SERO of SARS-CoV-2 antibodies SERO in France: results from nationwide serological surveillance

    Authors: Stephane Le Vu; Gabrielle Jones; Francois Anna; Thierry Rose; Jean-Baptiste Richard; Sibylle Bernard-Stoecklin; Sophie Goyard; Caroline Demeret; Olivier Helynck; Corinne Robin; Virgile Monnet; Louise Perrin de Facci; Marie-Noelle Ungeheuer; Lucie Leon; Yvonnick Guillois; Laurent Filleul; Pierre Charneau; Daniel Levy-Bruhl; Sylvie van der Werf; Harold Noel; Eran Friedler; Yael Gilboa; Sara Sabach; Yuval Alfiya; Uta Cheruti; Nadav Davidovitch; Natalya Bilenko; Jacob Moran-Gilad; Yakir Berchenko; Itay Bar-Or; Ariel Kushmaro; Timothy Spector; Claire J Steves

    doi:10.1101/2020.10.20.20213116 Date: 2020-10-21 Source: medRxiv

    Background Assessment of cumulative incidence of SARS-CoV-2 infections MESHD is critical for monitoring the course and the extent of the epidemic. As asymptomatic TRANS or mild cases were typically not captured by surveillance data in France, we implemented nationwide serological surveillance. We present estimates for prevalence SERO of anti- SARS-CoV-2 antibodies SERO in the French population and the proportion of infected individuals who developed potentially protective neutralizing antibodies SERO throughout the first epidemic wave. Methods We performed serial cross-sectional sampling of residual sera over three periods: prior to (9-15 March), during (6-12 April) and following (11-17 May) a nationwide lockdown. Each sample was tested for anti-SARS-CoV-2 SERO IgG antibodies SERO targeting the Nucleoprotein and Spike using two Luciferase-Linked ImmunoSorbent Assays, and for neutralising antibodies SERO using a pseudo-neutralisation assay. We fitted a general linear mixed model of seropositivity in a Bayesian framework to derive prevalence SERO estimates stratified by age TRANS, sex and region. Findings In total, sera from 11 021 individuals were analysed. Nationwide seroprevalence SERO of SARS-CoV-2 antibodies SERO was estimated at 0.41% [0.05;0.88] mid-March, 4.14% [3.31;4.99] mid-April and 4.93% [4.02;5.89] mid-May. Approximately 70% of seropositive individuals had detectable neutralising antibodies SERO. Seroprevalence SERO was higher in regions where circulation occurred earlier and was more intense. Seroprevalence SERO was lowest in children TRANS under 10 years of age TRANS (2.72% [1.10;4.87]). Interpretation Seroprevalence SERO estimates confirm that the nationwide lockdown substantially curbed transmission TRANS and that the vast majority of the French population remains susceptible to SARS-CoV-2. Low seroprevalence SERO in school age TRANS children TRANS suggests limited susceptibility and/or transmissibility TRANS in this age group TRANS. Our results show a clear picture of the progression of the first epidemic wave and provide a framework to inform the ongoing public health response as viral transmission TRANS is picking up again in France and globally.

    Temporal course of SARS-CoV-2 antibody SERO positivity in patients with COVID-19 following the first clinical presentation

    Authors: Martin Risch; Myriam Weber; Sarah Thiel; Kirsten Grossmann; Nadia Wohlwend; Thomas Risch; Dorothea Hillmann; Michael Ritzler; Francesca Ferrara; Susanna Bigler; Konrad Egli; Thomas Bodmer; Mauro Imperiali; Yacir Salimi; Felix Fleisch; Alexia Cusini; Harald Renz; Philipp Kohler; Pietro Vernazza; Christian R Kahlert; Matthias Paprotny; Lorenz Risch; Fanping Meng; Yanning Song; Yongpei Yu; Jiqiu Wen; Qi Li; Qing Mao; Markus Maeurer; Alimuddin Zumla; Chen Yao; Weifen Xie; Fu-Sheng Wang; Anthony Atala; Ali Ghodsizad; Joshua M Hare

    doi:10.1101/2020.10.17.20214445 Date: 2020-10-20 Source: medRxiv

    Knowledge of the sensitivities SERO of severe acute respiratory syndrome coronavirus-2 MESHD ( SARS-CoV-2) antibody SERO tests beyond 35 days after the clinical onset of COVID-19 is insufficient. We aimed to describe positivity rate of SARS-CoV-2 assays employing three different measurement principles over a prolonged period. Two hundred sixty-eight samples from 180 symptomatic patients with COVID-19 and a reverse transcription polymerase chain reaction (RT-PCR) test followed by serological investigation of SARS-CoV-2 antibodies SERO were included.. We conducted three chemiluminescence (including electrochemiluminscence, ECLIA), four enzyme linked immunosorbent assay SERO ( ELISA SERO), and one lateral flow immunoassay SERO (LFIA) test formats. Positivity rates, as well as positive (PPV) and negative predictive values SERO (NPV) were calculated for each week after the first clinical presentation for COVID-19. Furthermore, combinations of tests were assessed within an orthogonal testing approach employing two independent assays and predictive values were calculated. Heat maps were constructed to graphically illustrate operational test characteristics. During a follow-up period of more than 9 weeks, chemiluminescence assays and one ELISA IgG SERO test showed stable positivity rates after the third week. With the exception of ECLIA, the PPVs of the other chemiluminescence assays were [≥]95% for COVID-19 only after the second week. ELISA SERO and LFIA had somewhat lower PPVs. IgM exhibited insufficient predictive characteristics. An orthogonal testing approach provided PPVs [≥]95% for patients with a moderate pretest probability (e.g., symptomatic patients), even for tests with a low single test performance SERO. After the second week, NPVs of all but IgM assays were [≥]95% for patients with low to moderate pretest probability. The confirmation of negative results using an orthogonal algorithm with another assay provided lower NPVs than the single assays. When interpreting results from SARS-CoV-2 tests, the pretest probability, time of blood SERO draw and assay characteristics must be carefully considered. An orthogonal testing approach increases the accuracy of positive, but not negative, predictions.

    FebriDx point-of-care test in patients with suspected COVID-19: a pooled diagnostic accuracy study

    Authors: Samuel G Urwin; B Clare Lendrem; Jana Suklan; Kile Green; Sara Graziadio; Peter Buckle; Paul M Dark; Adam L Gordon; Daniel S Lasserson; Brian Nicholson; D Ashley Price; Charles Reynard; Mark H Wilcox; Graham Prestwich; Valerie Tate; Tristan W Clark; Raja V Reddy; Richard Body; A Joy Allen; Alejandro B Balazs; Hong Han; Laurence Pelletier; Jeffrey L Wrana

    doi:10.1101/2020.10.15.20213108 Date: 2020-10-20 Source: medRxiv

    Background: Point-of-care ( POC) tests SERO for COVID-19 could relieve pressure on isolation resource, support infection MESHD prevention and control, and help commence more timely and appropriate treatment. We aimed to undertake a systematic review and pooled diagnostic test accuracy study of available individual patient data (IPD) to evaluate the diagnostic accuracy of a commercial POC test SERO (FebriDx) in patients with suspected COVID-19. Methods: A literature search was performed on the 1st of October 2020 to identify studies reporting diagnostic accuracy statistics of the FebriDx POC test SERO versus real time reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Studies were screened for risk of bias. IPD were sought from studies meeting the inclusion and exclusion criteria. Logistic regression was performed to investigate the study effect on the outcome of the RT-PCR test result in order to determine whether it was appropriate to pool results. Diagnostic accuracy statistics were calculated with 95% confidence intervals (CIs). Results: 15 studies were screened, and we included two published studies with 527 hospitalised patients. 523 patients had valid FebriDx results for Myxovirus resistance protein A (MxA), an antiviral host response protein. The FebriDx test produced a pooled sensitivity SERO of 0.920 (95% CI: 0.875-0.950) and specificity of 0.862 (0.819-0.896) compared with RT-PCR, where there was an estimated true COVID-19 prevalence SERO of 0.405 (0.364-0.448) and overall FebriDx test yield was 99.2%. Patients were tested at a median of 4 days [interquartile range: 2:9] after symptom onset TRANS. No differences were found in a sub-group analysis of time tested since the onset of symptoms TRANS. Conclusions: Based on a large sample of patients from two studies during the first wave of the SARS-CoV-2 pandemic, the FebriDx POC test SERO had reasonable diagnostic accuracy in a hospital setting with high COVID-19 prevalence SERO, out of influenza season. More research is required to determine how FebriDx would perform in other healthcare settings with higher or lower COVID-19 prevalence SERO, different patient populations, or when other respiratory infections MESHD are in circulation.

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MeSH Disease
Human Phenotype

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