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    Reproducibility and sensitivity SERO of 36 methods to quantify the SARS-CoV-2 genetic signal in raw wastewater: findings from an interlaboratory methods evaluation in the U.S.

    Authors: Brian M Pecson; Emily Darby; Charles N Haas; Yamrot Amha; Mitchel Bartolo; Richard Danielson; Yeggie Dearborn; George Di Giovanni; Christobel Ferguson; Stephanie Fevig; Erica Gaddis; Don Gray; George Lukasik; Bonnie Mull; Liana Olivas; Adam Olivieri; Yan Qu; - SARS-CoV-2 Interlaboratory Consortium

    doi:10.1101/2020.11.02.20221622 Date: 2020-11-04 Source: medRxiv

    In response to COVID-19 MESHD, the international water community rapidly developed methods to quantify the SARS-CoV-2 genetic signal in untreated wastewater. Wastewater surveillance using such methods has the potential to complement clinical testing in assessing community health. This interlaboratory assessment evaluated the reproducibility and sensitivity SERO of 36 standard operating procedures (SOPs), divided into eight method groups based on sample concentration approach and whether solids were removed. Two raw wastewater samples were collected in August 2020, amended with a matrix spike (betacoronavirus OC43), and distributed to 32 laboratories across the U.S. Replicate samples analyzed in accordance with the project's quality assurance plan showed high reproducibility across the 36 SOPs: 80% of the recovery-corrected results fell HP within a band of +/- 1.15-log10 genome copies/L with higher reproducibility observed within a single SOP (standard deviation of 0.13-log10). The inclusion of a solids removal step and the selection of a concentration method did not show a clear, systematic impact on the recovery-corrected results. Other methodological variations (e.g., pasteurization, primer set selection, and use of RT-qPCR or RT-dPCR platforms) generally resulted in small differences compared to other sources of variability. These findings suggest that a variety of methods are capable of producing reproducible results, though the same SOP or laboratory should be selected to track SARS-CoV-2 trends at a given facility. The methods showed a 7-log10 range of recovery efficiency and limit of detection highlighting the importance of recovery correction and the need to consider method sensitivity SERO when selecting methods for wastewater surveillance.

    Efficient SARS-CoV-2 detection in unextracted oro-nasopharyngeal specimens by rRT-PCR with the Seegene AllplexTM 2019-nCoV assay

    Authors: Wesley Freppel; Natacha Merindol; Fabien Rallu; Marco Bergevin

    doi:10.21203/rs.3.rs-86922/v1 Date: 2020-10-02 Source: ResearchSquare

    The fight against the COVID-19 MESHD pandemic has created an urgent need to detect and isolate infected people MESHD. The challenge for clinical laboratories has been finding a high throughput, cheap, and efficient testing method in the context of extraction reagent shortages on a planetary scale. To answer this need, we studied SARS-CoV-2 detection in nasopharyngeal swabs stored in UTM (Universal Transport Media) or RNAse-free water by rRT-PCR with the Seegene Allplex TM 2019-nCoV assay without RNA extraction. Optimal results were obtained with 1/2 dilution for swabs in RNAse free water (30/30 detected) and 1/5 dilution for swabs in UTM (29/30 detected) followed by thermal lysis. In addition, a proteinase K (PK) treatment allows a significant reduction of invalid results and increases sensitivity SERO for detection of low viral load specimens. In a panel of 90 known positives with all 3 viral genes present and N gene Ct values from 15 to 40, our detection rate was 98.9% with PK and 94.4% without. In a panel of 60 low positives with only the N gene detectable at Ct values > 30, the detection rate was 76.7% with PK vs 53.3% without it and the invalid rate fell HP off from 18.3% to 0%. Furthermore, we demonstrated that our method reliably detects specimens with Ct values up to 35, however false negatives become frequent above this range. Finally, we show that swabs should be stored at -70 o C rather than 4 o C when testing cannot be performed within 72 hours of collection when laboratories are overwhelmed.

    Selecting COVID-19 MESHD Convalescent Plasma SERO for Neutralizing Antibody SERO Neutralizing Antibody MESHD Potency Using a High-capacity SARS-CoV-2 Antibody SERO Assay

    Authors: Erin Goodhue Meyer; Graham Simmons; Eduard Grebe; Michael Gannett; Sergej Franz; Orsolya Darst; Clara Di Germanio; Mars Stone; Paul Contestable; Alicia Prichard; Rita Reik; Ralph Vassallo; Pampee Young; Michael Busch; Phillip Williamson; Larry Dumont; Ruchee Shrestha; Andrew D Redd; Richard Eric Rothman; David J Sullivan; Shmuel Shoham; Arturo Casadevall; Thomas C. Quinn; Andrew Pekosz; Aaron AR Tobian; Oliver Laeyendecker; William Damsky; David van Dijk; Alfred Ian Lee; Hyung Chun; Akhil Vaid; Guillermo Barturen; Scott R. Tyler; Hardik Shah; Yinh-chih Wang; Shwetha Hara Sridhar; Juan Soto; Swaroop Bose; Kent Madrid; Ethan Ellis; Elyze Merzier; Konstantinos Vlachos; Nataly Fishman; Manying Tin; Melissa Smith; Hui Xie; Manishkumar Patel; Kimberly Argueta; Jocelyn Harris; Neha Karekar; Craig Batchelor; Jose Lacunza; Mahlet Yishak; Kevin Tuballes; Leisha Scott; Arvind Kumar; Suraj Jaladanki; Ryan Thompson; Evan Clark; Bojan Losic; - The Mount Sinai COVID-19 Biobank Team; Jun Zhu; Wenhui Wang; Andrew Kasarskis; Benjamin S. Glicksberg; Girish Nadkarni; Dusan Bogunovic; Cordelia Elaiho; Sandeep Gangadharan; George Ofori-Amanfo; Kasey Alesso-Carra; Kenan Onel; Karen M. Wilson; Carmen Argmann; Marta E. Alarcón-Riquelme; Thomas U. Marron; Adeeb Rahman; Seunghee Kim-Schulze; Sacha Gnjatic; Bruce D. Gelb; Miriam Merad; Robert Sebra; Eric E. Schadt; Alexander W. Charney

    doi:10.1101/2020.08.31.20184895 Date: 2020-09-02 Source: medRxiv

    BACKGROUND: Efficacy of COVID-19 MESHD convalescent plasma SERO (CCP) to treat COVID-19 MESHD is hypothesized to be associated with the concentration of neutralizing antibodies SERO (nAb) to SARS-CoV-2. High capacity serologic assays detecting binding antibodies SERO (bAb) have been developed, nAb assays are not adaptable to high-throughput testing. We sought to determine the effectiveness of using surrogate bAb signal-to-cutoff ratios (S/CO) in predicting nAb titers using a pseudovirus reporter viral particle neutralization (RVPN) assay. METHODS: CCP donor serum SERO collected by 3 US blood SERO collectors was tested with a bAb assay (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and a nAb RVPN assay. CoV2T prediction effectiveness at S/CO thresholds was evaluated for RVPN nAb NT50 titers using receiver operating characteristic analysis. RESULTS: 753 CCPs were tested with median CoV2T S/CO of 71.2 and median NT50 of 527.5. Proportions of CCP donors with NT50 over various target nAb titers were 86% [≥]1:80, 76% [≥]1:160, and 62%[≥]1:320. Increasing CoV2Ts reduced the sensitivity SERO to predict NT50 titers, while specificity to identify those below thresholds increased. As the targeted NT50 increased, the positive predictive value SERO fell HP with reciprocal increase in negative predictive value SERO. S/CO thresholds were thus less able to predict target NT50 titers. CONCLUSION: Selection of a clinically effective nAb titer will impact availability of CCP. Product release with CoV2T assay S/CO thresholds must balance the risk of releasing products below target nAb titers with the cost of false negatives. A two-step testing scheme may be optimal, with nAb testing on CoV2T samples with S/COs below thresholds.

    Seroprevalence SERO and immunity of SARS-CoV-2 infection MESHD in children TRANS and adolescents in schools in Switzerland: design for a longitudinal, school-based prospective cohort study

    Authors: Agne Ulyte; Thomas Radtke; Irene Abela; Sarah H Haile; Julia Braun; Ruedi Jung; Christoph Berger; Alexandra Trkola; Jan Fehr; Milo A Puhan; Susi Kriemler; Anel Nurtay; Lucie Abeler-Dörner; David G Bonsall; Michael V McConnell; Shawn O'Banion; Christophe Fraser; Scott Roberts; Jose A. Gonzalez; Marciano Sablad; Rodrigo Yelin; Wendy Taylor; Kiyoshi Tachikawa; Suezanne Parker; Priya Karmali; Jared Davis; Sean M Sullivan; Steve G. Hughes; Pad Chivukula; Eng Eong Ooi

    doi:10.1101/2020.08.30.20184671 Date: 2020-09-02 Source: medRxiv

    Introduction Seroprevalence SERO and transmission TRANS routes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection MESHD in children TRANS and adolescents, especially in school setting, are not clear. Resulting uncertainty is reflected in very different decisions on school closures and reopenings across countries. The aim of this longitudinal cohort study is to assess the extent and patterns of seroprevalence SERO of SARS-CoV-2 antibodies SERO in school-attending children TRANS repeatedly. It will examine risk factors for infection, relationship between seropositivity and symptoms, and temporal persistence of antibodies SERO. Additionally, it will include testing of school personnel and parents TRANS. Methods and analysis The study (Ciao Corona) will enroll a regionally representative, random sample of schools in the canton of Zurich, where 18% of the Swiss population live. Children TRANS aged TRANS 5 to 16 years, attending classes in primary and secondary schools are invited. Venous blood MESHD blood SERO and saliva samples are collected for SARS-CoV-2 serological testing SERO after the first wave of infections (June/July 2020), in fall HP (October/November 2020), and after winter (March/April 2021). Venous blood MESHD blood SERO is also collected for serological testing SERO of parents TRANS and school personnel. Bi-monthly questionnaires to children TRANS, parents TRANS and school personnel cover SARS-CoV-2 symptoms MESHD and tests, health, preventive behavior, lifestyle and quality of life information. Total seroprevalence SERO and cumulative incidence will be calculated. Hierarchical Bayesian logistic regression models will account for sensitivity SERO and specificity of the serological test SERO in the analyses and for the complex sampling structure, i.e., clustering within classes and schools. Ethics and dissemination The study was approved by the Ethics Committee of the Canton of Zurich, Switzerland (2020-01336). The results of this study will be published in peer-reviewed journals and will be made available to study participants and participating schools, the Federal Office of Public Health, and the Educational Department of the canton of Zurich. Trial registration number NCT04448717.

    Testing for coronavirus (SARS-CoV-2) infection MESHD in populations with low infection MESHD prevalence SERO: the largely ignored problem of false positives and the value of repeat testing

    Authors: Cathie Sudlow; Peter Diggle; Oliver Warlow; David Seymour; Ben Gordon; Rhos Walker; Charles Warlow

    doi:10.1101/2020.08.19.20178137 Date: 2020-08-22 Source: medRxiv

    Background: Calls are increasing for widespread SARS-CoV-2 infection MESHD testing of people from populations with a very low prevalence SERO of infection. We quantified the impact of less than perfect diagnostic test accuracy on populations, and on individuals, in low prevalence SERO settings, focusing on false positives and the role of confirmatory testing. Methods: We developed a simple, interactive tool to assess the impact of different combinations of test sensitivity SERO, specificity and infection prevalence SERO in a notional population of 100,000. We derived numbers of true positives, true negatives, false positives and false negatives, positive predictive value SERO (PPV, the percentage of test positives that are true positives) and overall test accuracy for three testing strategies: (1) single test for all; (2) add repeat testing in test positives; (3) add further repeat testing in those with discrepant results. We also assessed the impact on test results for individuals having one, two or three tests under these three strategies. Results: With sensitivity SERO of 80%, infection prevalence SERO of 1 in 2,000, and specificity 99.9% on all tests, PPV in the tested population of 100,000 will be only 29% with one test, increasing to >99.5% (100% when rounded to the nearest %) with repeat testing in strategies 2 or 3. More realistically, if specificity is 95% for the first and 99.9% for subsequent tests, single test PPV will be only 1%, increasing to 86% with repeat testing in strategy 2, or 79% with strategy 3 (albeit with 6 fewer false negatives than strategy 2). In the whole population, or in particular individuals, PPV increases as infection becomes more common in the population but falls HP to unacceptably low levels with lower test specificity. Conclusion: To avoid multiple unnecessary restrictions on whole populations, and in particular individuals, from widespread population testing for SARS-CoV-2, the crucial roles of extremely high test specificity and of confirmatory testing must be fully appreciated and incorporated into policy decisions.

    Validation of Saliva and Self-Administered Nasal Swabs for COVID-19 MESHD Testing

    Authors: Alvin Kuo Jing Teo; Yukti Choudhury; Iain Beehuat Tan; Chae Yin Cher; Shi Hao Chew; Zi Yi Wan; Lionel Tim Ee Cheng; Lynette Lin Ean Oon; Min Han Tan; Kian Sing Chan; Li Yang Hsu; Ramgyan Yadav; Ashish Timalsina; Chetan Nidhi Wagle; Brij Kumar Das; Ramesh Kunwar; Binaya Chalise; Deepak Raj Bhatta; Mukesh Adhikari; Michael Gale; Daniel J Campbell; David Rawlings; Marion Pepper

    doi:10.1101/2020.08.13.20173807 Date: 2020-08-14 Source: medRxiv

    Background Active cases of COVID-19 MESHD has primarily been diagnosed via RT-PCR of nasopharyngeal (NP) swabs. Saliva and self-administered nasal (SN) swabs can be collected safely without trained staff. We aimed to test the sensitivity SERO of naso-oropharyngeal saliva and SN swabs compared to NP swabs in a large cohort of migrant workers in Singapore. Methods We recruited 200 male TRANS adult TRANS subjects: 45 with acute respiratory infection MESHD, 104 asymptomatic TRANS close contacts TRANS, and 51 confirmed COVID-19 MESHD cases. Each subject underwent NP swab, SN swab and saliva collection for RT-PCR testing at 1 to 3 timepoints. We additionally used a direct-from-sample amplicon-based next-generation sequencing (NGS) workflow to establish phylogeny. Results Of 200 subjects, 91 and 46 completed second and third rounds of testing, respectively. Of 337 sets of tests, there were 150 (44.5%) positive NP swabs, 127 (37.7%) positive SN swabs, and 209 (62.0%) positive saliva. Test concordance between different sample sites was good, with a kappa statistic of 0.616 for NP and SN swabs, and 0.537 for NP and saliva. In confirmed symptomatic COVID-19 MESHD subjects, the likelihood of a positive test from any sample fell HP beyond 14 days of symptom onset TRANS. NGS was conducted on 18 SN and saliva samples, with phylogenetic analyses demonstrating lineages for all samples tested were Clade O (GISAID nomenclature) and lineage B.6 (PANGOLIN nomenclature). Conclusion This study supports saliva as a sensitive and less intrusive sample for COVID-19 MESHD diagnosis and further delineates the role of oropharyngeal secretions in increasing the sensitivity SERO of testing. However, SN swabs were inferior as an alternate sample type. Our study also provides evidence that a straightforward next-generation sequencing workflow can provide direct-from-sample phylogenetic analysis for public health decision-making.

    Fighting COVID-19 MESHD spread among nursing home residents even in absence of molecular diagnosis: a retrospective cohort study.

    Authors: Alessio Strazzulla; Paul Tarteret; Maria Concetta Postorino; Marie Picque; Astrid de Pontfarcy; Nicolas Vignier; Catherine Chakvetadze; Coralie Noel; Cecile Drouin; Zine Eddine Benguerdi; Sylvain Diamantis

    doi:10.21203/rs.3.rs-51305/v1 Date: 2020-07-30 Source: ResearchSquare

    Background Access to molecular diagnosis was limited out-of-hospital in France during the 2020 coronavirus disease 2019 MESHD ( COVID-19 MESHD) epidemic. This study describes the evolution of COVID-19 MESHD outbreak in a nursing home in absence of molecular diagnosis. Methods A monocentric prospective study was conducted in a French nursing home from March 17th, 2020 to June 11th, 2020. Because of lack of molecular tests for severe acute respiratory syndrome 2 (SARS-Cov2) infection MESHD, probable COVID-19 MESHD cases were early identified considering only respiratory and not-respiratory symptoms and therefore preventing measures and treatments were enforced. Once available, serology tests were performed at the end of the study.A chronologic description of new cases and deaths MESHD was made together with a description of COVID-19 MESHD symptoms. Data about personal characteristics and treatments were collected and the following comparisons were performed: i) probable COVID-19 MESHD cases vs asymptomatic TRANS residents; ii) SARS-Cov2 seropositive residents vs seronegative residents. Results Overall, 32/66 (48.5%) residents and 19/39 (48.7%) members of health-care personnel were classified as probable COVID-19 MESHD cases. A total of 34/61 (55.7%) tested residents resulted seropositive. Death occurred in 4/66 (6%) residents. Diagnosis according to symptoms had 65% of sensitivity SERO, 78% of specificity, 79% of positive predictive value SERO and 64% of negative predictive value SERO.In resident population, the following symptoms were registered: 15/32 (46.8%) lymphopenia MESHD lymphopenia HP, 15/32 (46.8%) fever HP fever MESHD, 8/32 (25%) fatigue MESHD fatigue HP, 8/32 (25%) cough HP, 6/32 (18.8%) diarrhoea MESHD, 4/32 (12.5%) severe respiratory distress HP requiring oxygen therapy, 4/32 (12.5%) fall HP, 3/32 (9.4%) conjunctivitis MESHD conjunctivitis HP, 2/32 (6.3%) abnormal pulmonary noise at chest examination and 2/32 (6,25%) abdominal pain MESHD abdominal pain HP. Probable COVID-19 MESHD cases were older (81.3 vs 74.9; p=0.007) and they had higher prevalence SERO of atrial fibrillation HP atrial fibrillation MESHD (8/32, 25% vs 2/34, 12%; p=0.030); insulin treatment (4/34, 12% vs 0, 0%; p=0.033) and positive SARS-Cov2 serology (22/32, 69% vs 12/34, 35%; p=0.001) than asymptomatic TRANS residents. Seropositive residents had lower prevalence SERO of diabetes MESHD (4/34, 12% vs 9/27, 33%; p=0.041) and angiotensin-converting-enzyme inhibitors’ intake (1/34, 1% vs 5/27, 19%; p=0.042). Conclusions During SARS-Cov2 epidemic, early detection of respiratory and not-respiratory symptoms allowed to enforce extraordinary measures. They achieved limiting contagion and deaths among nursing home residents, even in absence of molecular diagnosis.

    Evaluating SARS-CoV-2 spike MESHD and nucleocapsid proteins as targets for IgG antibody SERO detection in severe and mild COVID-19 MESHD cases using a Luminex bead-based assay

    Authors: Joachim Marien; Johan Michiels; Leo Heyndrickx; Karen Kerkhof; Nikki Foque; Marc-Alain Widdowson; Isabelle Desombere; Hilde Jansens; Marjan Van Esbroeck; Kevin K. Arien

    doi:10.1101/2020.07.25.20161943 Date: 2020-07-27 Source: medRxiv

    Large-scale serosurveillance of severe acute respiratory syndrome coronavirus type 2 MESHD (SARS-CoV-2) will only be possible if serological tests SERO are sufficiently reliable, rapid and inexpensive. Current assays are either labour-intensive and require specialised facilities (e.g. virus neutralization assays), or expensive with suboptimal specificity (e.g. commercial ELISAs SERO). Bead-based assays offer a cost-effective alternative and allow for multiplexing to test for antibodies SERO of other pathogens. Here, we compare the performance SERO of four antigens for the detection of SARS-CoV-2 specific IgG antibodies SERO in a panel of sera that includes both severe (n=40) and mild (n=52) cases, using a neutralization and a Luminex bead-based assay. While we show that neutralising antibody SERO levels are significantly lower in mild than in severe cases, we demonstrate that a combination of recombinant nucleocapsid protein (NP), receptor-binding domain (RBD) and the whole spike protein (S1S2) results in a highly sensitive (96%) and specific (99%) bead-based assay that can detect IgG antibodies SERO in both groups. Although S1-specific IgG levels correlate most strongly with neutralizing antibody SERO levels, they fall HP below the detection threshold in 10% of the cases in our Luminex assay. In conclusion, our data supports the use of RBD, NP and S1S2 for the development of SARS-CoV-2 serological bead-based assays. Finally, we argue that low antibody SERO levels in mild/ asymptomatic TRANS cases might complicate the epidemiological assessment of large-scale surveillance studies.

    FIREBall-2: The Faint Intergalactic Medium Redshifted Emission Balloon Telescope

    Authors: Erika Hamden; D. Christopher Martin; Bruno Milliard; David Schiminovich; Shouleh Nikzad; Jean Evrard; Gillian Kyne; Robert Grange; Johan Montel; Etienne Pirot; Keri Hoadley; Donal O'Sullivan; Nicole Melso; Vincent Picouet; Didier Vibert; Philippe Balard; Patrick Blanchard; Marty Crabill; Sandrine Pascal; Frederi Mirc; Nicolas Bray; April Jewell; Julia Blue Bird; Jose Zorilla; Hwei Ru Ong; Mateusz Matuszewski; Nicole Lingner; Ramona Augustin; Michele Limon; Albert Gomes; Pierre Tapie; Xavier Soors; Isabelle Zenone; Muriel Saccoccio

    id:2007.08528v1 Date: 2020-07-16 Source: arXiv

    The Faint Intergalactic Medium Redshifted Emission Balloon (FIREBall) is a mission designed to observe faint emission from the circumgalactic medium of moderate redshift (z~0.7) galaxies for the first time. FIREBall observes a component of galaxies that plays a key role in how galaxies form and evolve, likely contains a significant amount of baryons, and has only recently been observed at higher redshifts in the visible. Here we report on the 2018 flight of the FIREBall-2 Balloon telescope, which occurred on September 22nd, 2018 from Fort Sumner, New Mexico. The flight was the culmination of a complete redesign of the spectrograph from the original FIREBall fiber-fed IFU to a wide-field multi-object spectrograph. The flight was terminated early due to a hole in the balloon, and our original science objectives were not achieved. The overall sensitivity SERO of the instrument and telescope was 90,000 LU, due primarily to increased noise from stray light. We discuss the design of the FIREBall-2 spectrograph, modifications from the original FIREBall payload, and provide an overview of the performance SERO of all systems. We were able to successfully flight test a new pointing control system, a UV-optimized, delta-doped and coated EMCCD, and an aspheric grating. The FIREBall-2 team is rebuilding the payload for another flight attempt in the Fall HP of 2021, delayed from 2020 due to COVID-19 MESHD.

    Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post- COVID-19 MESHD infection syndromes: results from a pilot service

    Authors: Nicola Sweeney; Blair Merrick; Suzanne Pickering; Rui Pedro Galao; Alina Botgros; Harry D. Wilson; Adrian W. Signell; Gilberto Betancor; Mark Kia Ik Tan; John Ramble; Neophytos Kouphou; Sam Acors; Carl Graham; Jeffrey Seow; Eithne MacMahon; Stuart J. D. Neil; Michael H. Malim; Katie Doores; Sam Douthwaite; Rahul Batra; Gaia Nebbia; Jonathan D. Edgeworth

    doi:10.1101/2020.07.10.20150540 Date: 2020-07-11 Source: medRxiv

    Objectives: Determine indications and clinical utility of SARS-CoV-2 serology testing in adults TRANS and children TRANS. Design: Prospective evaluation of initial three weeks of a daily Monday to Friday pilot SARS-CoV-2 serology service for patients. Setting: Early post 'first-wave' SARS-CoV-2 transmission TRANS period at single centre London teaching hospital that provides care to the local community, as well as regional and national referral pathways for specialist services. Participants: 110 (72 adults TRANS, 38 children TRANS, age TRANS range 0-83 years, 52.7% female TRANS (n=58)). Interventions: Patient serum SERO from vetted referrals tested on CE marked and internally validated lateral flow immunoassay SERO (LFIA) (SureScreen Diagnostics) detecting antibodies to SARS-CoV-2 SERO spike proteins, with result and clinical interpretation provided to the direct care team. Main outcome measures: Performance SERO characteristics, source and nature of referrals, feasibility and clinical utility of the service, particularly the benefit for clinical decision-making. Results: The LFIA was deemed suitable for clinical advice and decision making following evaluation with 310 serum samples SERO from SARS-CoV-2 PCR positive patients and 300 pre-pandemic samples, giving a sensitivity SERO and specificity of 96.1% and 99.3% respectively. For the pilot, 115 referrals were received leading to 113 tests performed on 108 participants (sample not available for two participants); paediatrics (n=35), medicine (n=69), surgery (n=2) and general practice (n=2). 43.4% participants (n=49) had detectable antibodies to SARS-CoV-2 SERO. There were three main indications for serology; new acute presentations potentially triggered by recent COVID-19 MESHD infection e.g. PIMS-TS (n=26) and pulmonary embolism MESHD pulmonary embolism HP (n=5), potential missed diagnoses in context of a recent compatible illness (n=40), and making infection control and immunosuppression treatment decisions in persistently SARS-CoV-2 RNA PCR positive individuals (n=6). Conclusions: This study shows acceptable performance SERO characteristics, feasibility and clinical utility of a SARS-CoV-2 serology service using a rapid, inexpensive and portable assay for adults TRANS and children TRANS presenting with a range of clinical indications. Results correlated closely with a confirmatory in-house ELISA SERO. The study showed the benefit of introducing a serology service where there is a reasonable pre-test probability, and the result can be linked with clinical advice or intervention. Experience thus far is that the volume of requests from hospital referral routes are manageable within existing clinical and laboratory services; however, the demand from community referrals has not yet been assessed. Given recent evidence for a rapid decline in antibodies SERO, particularly following mild infection, there is likely a limited window of opportunity to realise the benefit of serology testing for individuals infected during the 'first-wave' before they potentially fall HP below a measurable threshold. Rapidly expanding availability of serology services for NHS patients will also help understand the long-term implications of serostatus and prior infection in different patient groups, particularly before emergence of any 'second-wave' outbreak or introduction of a vaccination programme.

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