Corpus overview


Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    SARS-CoV-2 seroprevalence SERO survey among 18,000 healthcare and administrative personnel at hospitals, pre-hospital services, and specialist practitioners in the Central Denmark Region

    Authors: Sanne Jespersen; Susan Mikkelsen; Thomas Greve; Kathrine Agergaard Kaspersen; Martin Tolstrup; Jens Kjaergaard Boldsen; Jacob Dvinge Redder; Kent Nielsen; Anders Moensted Abildgaard; Henrik Albert Kolstad; Lars Oestergaard; Marianne Kragh Thomsen; Holger Jon Moeller; Christian Erikstrup

    doi:10.1101/2020.08.10.20171850 Date: 2020-08-12 Source: medRxiv

    Objectives: The objective of this study was to perform a large seroprevalence SERO survey on severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) among Danish healthcare workers to identify high risk groups. Design: Cross-sectional survey. Setting: All healthcare workers and administrative personnel at the seven hospitals, pre-hospital services and specialist practitioner clinics in the Central Denmark Region were invited by e-mail to be tested for antibodies SERO against SARS-CoV-2 by a commercial SARS-CoV-2 total antibody SERO enzyme-linked immunosorbent assay SERO ( ELISA SERO, Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing, China). Participants: A total of 25,950 participants were invited. Of these, 17,987 (69%) showed up for blood SERO sampling, and 17,971 had samples available for SARS-CoV-2 antibody SERO testing. Main outcome measures: 1) Prevalence SERO of SARS-CoV-2 antibodies SERO; 2) Risk factors for seropositivity; 3) Association of SARS-CoV-2 RNA and antibodies SERO. Results: After adjustment for assay sensitivity SERO and specificity, the overall seroprevalence SERO was 3.4% (CI: 2.5%-3.8%). The seroprevalence SERO was higher in the western part of the region than in the eastern part (11.9% vs 1.2%, difference: 10.7 percentage points, CI: 9.5-12.2). In the high prevalence SERO area, the emergency MESHD departments had the highest seroprevalence SERO (29.7%) while departments without patients or with limited patient contact had the lowest seroprevalence SERO (2.2%). Multivariable logistic regression analysis with age TRANS, sex, and profession as the predictors showed that nursing staff, medical doctors, and biomedical laboratory scientists had a higher risk than medical secretaries, who served as reference (OR = 7.3, CI: 3.5-14.9; OR = 4., CI: 1.8-8.9; and OR = 5.0, CI: 2.1-11.6, respectively). Among the total 668 seropositive participants, 433 (64.8%) had previously been tested for SARS-CoV-2 RNA, and 50.0% had a positive RT-PCR result. A total of 98% of individuals who had a previous positive viral RNA test were also found to be seropositive. Conclusions: We found large differences in the prevalence SERO of SARS-CoV-2 antibodies SERO in staff working in the healthcare sector within a small geographical area of Denmark and signs of in-hospital transmission TRANS. Half of all seropositive staff had been tested positive by PCR prior to this survey. This study raises awareness of precautions which should be taken to avoid in-hospital transmission TRANS. Additionally, regular testing of healthcare workers for SARS-CoV-2 should be considered to identify areas with increased transmission TRANS. Trial registration: The study is approved by the Danish Data Protection Agency (1-16-02-207-20).

    Low awareness of past SARS-CoV-2 infection MESHD in healthy adults TRANS

    Authors: Katja van den Hurk; Eva-Maria Merz; Femmeke J. Prinsze; Marloes L.C. Spekman; Franke A. Quee; Steven Ramondt; Ed Slot; Hans Vrielink; Elisabeth M.J. Huis in 't Veld; Hans L. Zaaijer; Boris M. Hogema

    doi:10.1101/2020.08.10.20171561 Date: 2020-08-12 Source: medRxiv

    Background The coronavirus disease MESHD 2019 (COVID-19) pandemic challenges governments worldwide to balance appropriate virus control measures and their societal and economic consequences. These control measures include the identification, isolation and testing of potentially infected individuals. As this relies on an individual's awareness of infection MESHD, we investigated the extent to which healthy adults TRANS suspected having had COVID-19, and how COVID-19 suspicion and symptoms relate to antibodies SERO indicative of a past infection MESHD infection with the severe HP with the severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). Methods and findings Individuals donating plasma SERO anywhere in the Netherlands between May 11th and 18th were screened for total SARS-CoV-2 antibodies SERO using ELISA SERO and invited to participate in an online questionnaire about COVID-19-related symptoms and awareness. Antibody SERO and questionnaire data were complete for 3,676 individuals, including 239 (6.5%) that tested positive for SARS-CoV-2 antibodies SERO. Here, we show that a 38% of the individuals that tested positive for SARS-CoV-2 antibodies SERO reported having had no or only very mild symptoms at any time during the peak of the epidemic. The loss of taste and/or smell in particular was significantly associated with seropositivity, independent of age TRANS and sex. Forty-eight percent of antibody SERO-positive persons did not suspect having had COVID-19, in spite of most of them reporting symptoms. Conclusions Awareness of infection MESHD was low among individuals that tested positive for SARS-CoV-2 antibodies SERO, even at the peak of the epidemic. Improved awareness and recognition of COVID-19 symptoms and tracing TRANS of asymptomatic TRANS contacts is crucial to halting SARS-CoV-2 transmission TRANS.

    Rapid Detection of SARS-CoV-2 Antibodies SERO Using Electrochemical Impedance-Based Detector

    Authors: Mohamed Z. Rashed; Jonathan A. Kopecheck; Mariah C. Priddy; Krystal T. Hamorsky; Kenneth E. Palmer; Nikhil Mittal; Joseph Valdez; Joseph Flynn; Stuart Williams

    doi:10.1101/2020.08.10.20171652 Date: 2020-08-11 Source: medRxiv

    Emerging novel human contagious viruses and pathogens put humans at risk of hospitalization and possibly death MESHD due to the unavailability of vaccines and drugs which may take years to develop. Coronavirus disease MESHD (COVID-19) caused by severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) was classified as a pandemic by the World Health Organization and has caused over 550,000 deaths MESHD worldwide as of July 2020. Accurate and scalable point-of-care devices would increase screening, diagnosis, and monitoring of COVID-19 patients. Here, we demonstrate rapid label-free electrochemical detection of SARS-CoV-2 antibodies SERO using a commercially available impedance sensing platform. A 16-well plate containing sensing electrodes was pre-coated with receptor binding domain (RBD) of SARS-CoV-2 spike protein, and subsequently tested with samples of anti-SARS-CoV-2 monoclonal antibody SERO CR3022 (0.1 g/ml, 1.0 g/ml, 10 g/ml). Subsequent blinded testing was performed on six serum SERO specimens taken from COVID-19 and non-COVID-19 patients (1:100 dilution factor). The platform was able to differentiate spikes in impedance measurements from a negative control (1% milk solution) for all CR3022 samples. Further, successful differentiation and detection of all positive clinical samples from negative control was achieved. Measured impedance values were consistent when compared to standard ELISA SERO test results showing a strong correlation between them (R2 = 0:9). Detection occurs in less than five minutes and the well-based platform provides a simplified and familiar testing interface that can be readily adaptable for use in clinical settings.

    The effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2 SERO, to inform COVID-19 diagnosis: a rapid systematic review

    Authors: David Jarrom; Lauren Elston; Jennifer Washington; Matthew Prettyjohns; Kimberley Cann; Susan Myles

    doi:10.1101/2020.08.10.20171777 Date: 2020-08-11 Source: medRxiv

    Objectives: We undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) to inform COVID-19 diagnosis? (2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 SERO virus to inform COVID-19 diagnosis? Design: systematic review and meta-analysis of studies of diagnostic test accuracy. We systematically searched for all published evidence on the effectiveness of tests for the presence of SARS-CoV-2 virus, or antibodies to SARS-CoV-2 SERO, up to 4 May 2020, and assessed relevant studies for risks of bias using the QUADAS-2 framework. Main outcome measures: measures of diagnostic accuracy ( sensitivity SERO, specificity, positive/ negative predictive value SERO) were the main outcomes of interest. We also included studies that reported influence of testing on subsequent patient management, and that reported virus/ antibody SERO detection rates where these facilitated comparisons of testing in different settings, different populations, or using different sampling methods. Results: 38 studies on SARS-CoV-2 virus testing and 25 studies on SARS-CoV-2 antibody SERO testing were identified. We identified high or unclear risks of bias in the majority of studies, most commonly as a result of unclear methods of patient selection and test conduct, or because of the use of a reference standard that may not definitively diagnose COVID-19. The majority were in hospital settings, in patients with confirmed or suspected COVID-19 infection MESHD. Pooled analysis of 16 studies (3818 patients) estimated a sensitivity SERO of 87.8% (95% confidence interval 81.5% to 92.2%) for an initial reverse-transcriptase polymerase chain reaction test. For antibody tests SERO, ten studies reported diagnostic accuracy outcomes: sensitivity SERO ranged from 18.4% to 96.1% and specificity 88.9% to 100%. However, the lack of a true reference standard for SARS-CoV-2 diagnosis makes it challenging to assess the true diagnostic accuracy of these tests. Eighteen studies reporting different sampling methods suggest that for virus tests, the type of sample obtained/type of tissue sampled could influence test accuracy. Finally we searched for, but did not identify, any evidence on how any test influences subsequent patient management. Conclusions: Evidence is rapidly emerging on the effectiveness of tests for COVID-19 diagnosis and management, but important uncertainties about their effectiveness and most appropriate application remain. Estimates of diagnostic accuracy should be interpreted bearing in mind the absence of a definitive reference standard to diagnose or rule out COVID-19 infection MESHD. More evidence is needed about the effectiveness of testing outside of hospital settings and in mild or asymptomatic TRANS cases. Implementation of public health strategies centred on COVID-19 testing provides opportunities to explore these important areas of research.

    Performance SERO of an automated anti-SARS-CoV-2 immunoassay SERO in prepandemic cohorts

    Authors: Elena Riester; Beda Krieter; Peter Findeisen; Michael Laimighofer; Kathrin Schoenfeld; Tina Laengin; Christoph Niederhauser

    doi:10.1101/2020.08.07.20169987 Date: 2020-08-07 Source: medRxiv

    Background: The Elecsys(R) Anti-SARS-CoV-2 immunoassay SERO (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay SERO in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland. Methods: Specificity of the immunoassay SERO was evaluated using anonymised, frozen, residual serum SERO and/or plasma SERO samples from blood SERO donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies SERO. Cohorts included samples from blood SERO donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated. Results: Overall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay SERO in 9575 samples from blood SERO donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100). Conclusion: The Elecsys Anti-SARS-CoV-2 immunoassay SERO demonstrated a very high specificity across blood SERO donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay SERO as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood SERO donors, pregnant women and paediatric populations.

    Specificity and Performance SERO of Nucleocapsid and Spike-based SARS-CoV-2 Serologic Assays

    Authors: Zahra Rikhtegaran Tehrani; Saman Saadat; Ebtehal Saleh; Xin Ouyang; Niel Constantine; Anthony L. DeVico; Anthony D. Harris; George K. Lewis; Shyam Kottilil; Mohammad M. Sajadi

    doi:10.1101/2020.08.05.20168476 Date: 2020-08-07 Source: medRxiv

    There is an urgent need for an accurate antibody test SERO for severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). In this paper, we have developed 3 ELISA SERO methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti- SARS-CoV-2 antibodies SERO. We evaluated their performance SERO in comparison with four commercial ELISAs SERO, EDI Novel Coronavirus COVID-19 ELISA IgG SERO and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG SERO and IgA, and one lateral flow assay, DPP COVID-19 IgM/IgG System (Chembio). Both sensitivity SERO and specificity were evaluated and the causes of false-positive reactions were determined. The assays were compared using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. The sensitivities SERO and specificities of the assays were as follows: 90%/100% (in-house trimer spike IgA), 90%/99.3% (in-house trimer spike IgG), 89%/98.3% (in-house nucleocapsid IgG), 73.7%/100% (EDI nucleocapsid IgM), 84.5%/95.1% (EDI nucleocapsid IgG), 95%/93.7% (Euroimmun S1 IgA), 82.8%/99.7% (Euroimmun S1 IgG), 82.0%/91.7% (Chembio nucleocapsid IgM), 92%/93.3% (Chembio nucleocapsid IgG). The presumed causes of positive signals from pre-epidemic samples in commercial and in-house assays were mixed. In some cases, positivity varied with assay repetition. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with analyte prior to performing the assay). In other cases, reactivity was consistently detected but not abrogated by analyte spiking. Overall, there was wide variability in assay performance SERO using our samples, with in-house tests exhibiting the highest combined sensitivity SERO and specificity. The causes of false positivity in pre-epidemic samples may be due to plasma SERO antibodies SERO apparently reacting with the analyte, or spurious reactivity may be directed against non-specific components in the assay system. Identification of these targets will be essential to improving assay performance SERO.

    Performance SERO assessment of 11 commercial serological tests SERO for SARS-CoV-2 on hospitalized COVID-19 patients

    Authors: Claudia Serre-Miranda; Claudia Nobrega; Susana Roque; Joao Canto-Gomes; Carolina S Silva; Neide Vieira; Palmira Barreira-Silva; Pedro Alves-Peixoto; Jorge Cotter; Ana Reis; Mariana Formigo; Helena Sarmento; Olga Pires; Alexandre Carvalho; Dmitri Y Petrovykh; Lorena Dieguez; Joao C Sousa; Nuno Sousa; Carlos Capela; Joana A Palha; Pedro G Cunha; Margarida Correia-Neves

    doi:10.1101/2020.08.06.20168856 Date: 2020-08-07 Source: medRxiv

    Commercial availability of serological tests SERO to evaluate immunoglobulins (Ig) towards severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) has grown exponentially since the onset of COVID-19 outbreak. Their thorough validation is of extreme importance before using them as epidemiological tools to infer population seroprevalence SERO, and as complementary diagnostic tools to molecular approaches (e.g. RT-qPCR). Here we assayed commercial serological tests SERO (semiquantitative and qualitative) from 11 suppliers in 126 samples collected from hospitalized COVID-19 patients, and from 36 healthy and HIV-infected individuals (collected at the pre-COVID-19 pandemic). Specificity was above 95% in 9 tests. Samples from COVID-19 patients were stratified by days since symptoms onset TRANS (<10, 10-15, 16-21 and >21 days). Tests sensitivity SERO increases with time since symptoms onset TRANS, and peaks at 16-21 days for IgM and IgA (maximum: 91.2%); and from 16-21 to >21 days for IgG, depending on the test (maximum: 94.1%). Data from semiquantitative tests show that patients with severe clinical presentation have lower relative levels of IgM, IgA and IgG at <10 days since symptoms onset TRANS in comparison to patients with non-severe presentation. At >21 days since symptoms onset TRANS the relative levels of IgM and IgG (in one test) are significantly higher in patients with severe clinical presentation, suggesting a delay in the upsurge of Ig against SARS-CoV-2 in those patients. This study highlights the high specificity of most of the evaluated tests, and sensitivity SERO heterogeneity. Considering the virus genetic evolution and population immune response to it, continuous monitoring of commercially available serological tests SERO towards SARS-CoV-2 is necessary.

    Serology assessment of antibody SERO response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test SERO

    Authors: Yang De Marinis; Torgny Sunnerhagen; Pradeep Bompada; Anna Blackberg; Runtao Yang; Joel Svensson; Ola Ekstrom; Karl-Fredrik Eriksson; Ola Hansson; Leif Groop; Isabel Goncalves; Magnus Rasmussen

    doi:10.1101/2020.08.05.20168815 Date: 2020-08-06 Source: medRxiv

    The coronavirus disease MESHD 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection MESHD. In this study, we applied a rapid COVID-19 IgM/IgG antibody test SERO and performed serology assessment of antibody SERO response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody SERO detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody SERO response in relation to time after symptom onset TRANS and disease MESHD severity, and observed an increase in antibody SERO reactivity and distinct distribution patterns of IgM and IgG following disease progression MESHD. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease MESHD onset; 85% in non-hospitalized patients with > 2 weeks disease MESHD duration; and 91% in hospitalized patients with > 2 weeks disease MESHD duration. We also compared different blood SERO sample types and suggest a potentially higher sensitivity SERO by serum SERO/ plasma SERO comparing with whole blood SERO measurement. To study the specificity of the test, we used 69 sera/ plasma SERO samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody SERO detection patterns in association with disease MESHD progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.

    Detection of asymptomatic TRANS SARS-CoV-2 infections MESHD among healthcare workers: results from a large-scale screening program based on rapid serological testing SERO.

    Authors: Francesca Maria Carozzi; Maria Grazia Cusi; Mauro Pistello; Luisa Galli; Alessandro Bartoloni; Gabriele Anichini; Chiara Azzari; Michele Emdin; Claudia Gandolfo; Fabrizio Maggi; Elisabetta Mantengoli; Maria Moriondo; Giovanna Moscato; Irene Paganini; Claudio Passino; Francesco Profili; Fabio Voller; Marco Zappa; Filippo Quattrone; Gian Maria Rossolini; Paolo Francesconi; - SARS-CoV-2 Serosurvey Tuscan Working Group

    doi:10.1101/2020.07.30.20149567 Date: 2020-08-04 Source: medRxiv

    Abstract Objective: To evaluate the performance SERO of two available rapid immunological tests for identification of severe acute respiratory syndrome MESHD Coronavirus 2 ( SARS-CoV-2) antibodies SERO and their subsequent application to a regional screening of health care workers (HCW) in Tuscany (Italy). Design: measures of accuracy and HCW serological surveillance Setting: 6 major health facilities in Tuscany, Italy. Participants: 17,098 HCW of the Tuscany Region. Measures of accuracy were estimated to assess sensitivity SERO in 176 hospitalized Covid-19 clinical subjects at least 14 days after a diagnostic PCR-positive assay result. Specificity was assessed in 295 sera biobanked in the pre-Covid-19 era in winter or summer 2013-14 Main outcome measures: Sensitivity SERO and specificity, and 95% confidence intervals, were measured using two serological tests SERO, named T-1 and T-2. Positive and Negative predictive values SERO were estimated at different levels of prevalence SERO. HCW of the health centers were tested using the serological SERO tests, with a follow- up nasopharyngeal PCR-test swab in positive tested cases. Results: Sensitivity SERO was estimated as 99% (95%CI: 95%-100%) and 97% (95% CI: 90%-100%), whereas specificity was the 95% and 92%, for Test T-1 and T-2 respectively. In the historical samples IgM cross-reactions were detected in sera collected during the winter period, probably linked to other human coronaviruses. Out of the 17,098 tested, 3.1% have shown the presence of SARS-CoV-2 IgG antibodies SERO, among them 6.8% were positive at PCR follow-up test on nasopharyngeal swabs. Conclusion Based on the low prevalence SERO estimate observed in this survey, the use of serological test SERO as a stand-alone test is not justified to assess the individual immunity status. Serological tests SERO showed good performance SERO and might be useful in an integrated surveillance, for identification of infected subjects and their contacts as required by the policy of contact tracing TRANS, with the aim to reduce the risk of dissemination, especially in health service facilities.

    Assessment of a Laboratory-Based SARS-CoV-2 Antibody SERO Test Among Hemodialysis Patients: A Quality Improvement Initiative

    Authors: Dena E Cohen; Gilbert Marlowe; Gabriel Contreras; Marie Ann Sosa; Jair Munoz Mendoza; Oliver Lenz; Zain Mithani; Pura Margarita Teixeiro; Nery Queija; Araceli Moneda; Jean S Jeanty; Katherine Swanzy; Misha Palecek; Mahesh Krishnan; Jeffery Giullian; Steven M Brunelli

    doi:10.1101/2020.08.03.20163642 Date: 2020-08-04 Source: medRxiv

    Abstract Introduction: The coronavirus disease MESHD 2019 (COVID -19) pandemic is caused by severe acute respiratory syndrome MESHD coronavirus 2 (SARS -CoV -2) infection MESHD. Although tests to detect anti - SARS -CoV-2 antibodies SERO have been developed, their sensitivity SERO and specificity in hemodialysis patients have not been previously assessed. Methods: As part of a quality improvement (QI) initiative, nasopharyngeal swabs and predialysis blood SERO samples were collected on the same day from adult TRANS patients receiving routine hemodialysis care at clinics managed by a large dialysis organization in the greater Miami, Florida region (23 - 30 Apr 2020). Polymerase chain reaction (PCR) tests for SARS -CoV -2 and chemiluminescence immunoassays SERO for anti -SARS -CoV2 antibodies SERO were performed according to manufacturer-specified protocols. Results: Of 715 participants in the QI initiative, 38 had symptomatology consistent with COVID -19 prior to or during the initiative. Among these, COVID -19 was PCR -confirmed in 14 and ruled out in 20, with the remaining 4 being inconclusive. Among the 34 patients with known COVID -19 status, the sensitivity SERO and specificity of the antibody test SERO were 57.1% and 85.0% when either antibody SERO was considered. The remaining 677 patients had no record of symptoms consistent with COVID -19, nor any known exposure. Of these, 38 patients (5.6%) tested positive for anti- SARS-CoV-2 antibodies SERO. Conclusions: The operational characteristics of the laboratory-based antibody test SERO make it sufficient to rule in, but not rule out, SARS -CoV -2 infection MESHD in the appropriate clinical circumstance. A substantial proportion of dialysis patients may have had asymptomatic TRANS SARS -CoV -2 infection MESHD.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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