Corpus overview


MeSH Disease

Human Phenotype


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    Performance SERO of a point of care test for detecting IgM and IgG antibodies SERO against SARS-CoV-2 and seroprevalence SERO in blood SERO donors and health care workers in Panama

    Authors: Alcibiades Villarreal; Giselle Rangel; Xu Zhang; Digna Wong; Carolina De La Guardia; Gabrielle Britton; Patricia Llanes; Carlos M Restrepo; Ambar Perez; Diana Oviedo; Maria B Carreira; Gilberto Skildsen; Dilcia Sambrano; Yamitzel Zaldivar; Danilo Franco; Sandra Lopez Verges; Dexi Zhang; Fanjing Fan; Baojun Wang; Xavier Saez Llorens; Rodrigo DeAntonio; Ivonne Torres-Atencio; Eduardo Ortega-Barria; Rao Kosagisharaf; Ricardo Lleonart; Li Chong; Amador Goodridge; - COVID-19 SEROLOGY COLLABORATOR GROUP

    doi:10.1101/2020.09.25.20201459 Date: 2020-09-25 Source: medRxiv

    Novel severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease MESHD 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in eight months. The serological detection of antibodies SERO against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing TRANS, vaccine efficacy testing and seroprevalence SERO surveillance. Here, we aimed first to evaluate a lateral flow assay ability to identify specific IgM and IgG antibodies SERO against SARS-CoV-2 and second, to report the seroprevalence SERO of these antibodies SERO among health care workers and healthy volunteer blood SERO donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance SERO evaluation, we analyzed serum samples SERO from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, participants with other confirmed infectious diseases MESHD, and a set of pre-pandemic serum samples SERO. We used two by two table analysis to determine the test sensitivity SERO and specificity as well as the kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence SERO among serum samples SERO from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2-100.0%) for detecting both IgM and IgG. The assay showed a kappa of 0.898 (95%CI 0.811- 0.985) and 0.918 (95% CI 0.839-0.997) for IgM and IgG, respectively. The evaluation of serum samples SERO from hospitalized COVID-19 patients indicates a correlation between test sensitivity SERO and the number of days since symptom onset TRANS; the highest positive percent agreement (87% (95% CI 67.0-96.3%)) was observed at [≥]15 days post- symptom onset TRANS. We found an overall antibody SERO seroprevalence SERO of 11.6% (95% CI 8.5-15.8%) among both health care workers and healthy blood SERO donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence SERO testing in locations with active community transmission TRANS of SARS-CoV-2.

    Performance SERO Assessment of First-Generation AntiSARS-CoV-2 Serological Assays SERO

    Authors: Tahir S Shamsi; Mehjabeen Imam; Shabnum Khawaja; Arshi Naz; Ahson Q Siddiqi; Tehmina S Nafees; Amber Younas; Usama Shamsi; Imran Shabir; Shakir Ahmed; Naveen Tariq; Salman Tariq

    doi:10.1101/2020.09.22.20197046 Date: 2020-09-24 Source: medRxiv

    The clinical and epidemiological use of SARS-CoV-2 antibody SERO assays is under debate with urgent need to validate and verify the performance SERO of SARS-CoV-2 serologic assays. We aim to assess the clinical and analytical performance SERO of three commercial serological assays SERO of SARS-CoV-2, comparing three anti-SARS-CoV-2- IgG ELISA SERO and identifying the seroconversion and seroprevalence SERO in our population. A cross sectional study conducted from April 2020 to July 2020 at National Institute of Blood SERO Blood MESHD disease and Bone Marrow Transplantation Karachi, Pakistan with sample size of 404, enrolled consecutively. Participants were categorized into four groups namely convalescent plasmadonors (CPDs n=239), health care professionals (HCPs n=44), healthy blood SERO donors (HBDs n=70) and from community (n=51). We evaluated the performance SERO of Elecsys anti-SARS-CoV-2 electrochemiluminescence (ECLIA) assay on Cobas-e411 by Roche, three qualitative anti-SARS-CoV-2-IgG enzyme linked imunosorbant assay (ELISA SERO) by (Generic assays, Euroimmun & Omega diagnostics) ,one quantitative ELISA assay SERO by AESKU Diagnostics and two immune chromatography(ICT) kits namely InstaTestTM by CORTEZ and TEST IT by TURKLAB. From total 404 subjects, 322 (83.5%) were males TRANS. Mean age TRANS was 36.79 plus minus 11.95 years. Among 239 in CPDs group, 202(84.5%) showed positive antibodies SERO by ECLIA. The qualitative anti-SARS-CoV-2 IgG ELISA SERO was positive in 174 (72.8%) and quantitative IgG in 180(75.3%) with mean titer of 56.7 plus minus 39.7 U/ml. Sensitivity SERO and specificity of ECLIA were 97.44& 99%, ELISA SERO by Generic assays were 67.85% and 89.9%; Euroimmun had 90.38% and 94.9%; Omega Diagnostics 96.4% and 95% and the AESKULISA 93.75% and 100% respectively. Seroconversion was found to be 53.8% and 77.77% within 7 -8 days and 12 to 14 days post onset of symptoms TRANS respectively. ICT had more specificity but less sensitivity SERO. Seroprevalence SERO was found to be 84.5%, 40.9% and 21.4% in CPDs, HCPs and HBDs respectively. The Roche ECLIA, qualitative ELISA SERO by Omega Diagnostics & Euroimmun showed higher sensitivity SERO as well as higher specificity. Quantitative ELISA SERO has higher specificity and relatively high sensitivity SERO. Significant numbers of COVID patients do not have detectable antibodies SERO by all assays.

    D-dimer dynamics in hospitalized COVID-19 patients: potential utility for diagnosis of pulmonary embolism HP pulmonary embolism MESHD.

    Authors: Pau Cerda; Jesus Ribas; Adriana Iriarte; Jose Maria Mora-Lujan; Raque Torres; Belen del Rio; Hector Ignacio Jofre; Yolanda Ruiz; Marta Huguet; Maria Paz Fuset; Sergio Martinez-Yelamos; Salud Santos; Nuria Llecha; Xavier Corbella; Antoni Riera-Mestre

    doi:10.1101/2020.09.21.20193953 Date: 2020-09-23 Source: medRxiv

    Background: A higher incidence of thrombotic MESHD events, mainly pulmonary embolism HP pulmonary embolism MESHD ( PE MESHD), has been reported in hospitalized patients with COVID-19. Objectives: To assess clinical and weekly laboratory differences in hospitalized COVID-19 patients according to occurrence of PE MESHD. Methods: This retrospective study included all consecutive patients hospitalized with COVID-19 who underwent a computed tomography (CT) angiography for PE MESHD clinical suspicion. Clinical data and median blood SERO test results distributed into weekly periods from COVID-19 symptoms onset TRANS were compared between PE MESHD and non- PE MESHD patients. Results: Ninety-two patients were included, 29 (32%) had PE MESHD. PE MESHD patients were younger (63.9 (SD13.7) vs 69.9 (SD12.5) years). Clinical symptoms and COVID-19 CT features were similar in both groups. PE MESHD was diagnosed after a mean of 20.0 (SD8.6) days from the onset of COVID-19 symptoms. Corticosteroid boluses were more frequently used in PE MESHD patients (62% vs. 43%). Median values [IQR] of D-dimer in PE MESHD vs non- PE MESHD patients were: week 2 (2010.7 [770.1-11208.9] vs 626.0 [374.0-2382.2]; p=0.04); 3 (3893.1 [1388.2-6694.0] vs 1184.4 [461.8-2447.8]; p=0.03); and 4 (2736.3 [1202.1-8514.1] vs 1129.1 [542.5-2834.6]; p=0.01). Median fold-increase of D-dimer between week 1 and 2 differed between groups (6.64 [3.02-23.05] vs 1.57 [0.64-2.71], p=0.003); ROC curve AUC was 0.879 (p=0.003) with a sensitivity SERO and specificity for PE MESHD of 86% and 80%, respectively. Conclusions: Among hospitalized COVID-19 patients, D-dimer levels are higher at weeks 2, 3 and 4 after COVID-19 symptom onset TRANS in patients who develop PE MESHD. This difference is more pronounced when the fold increase between weeks 1 and 2 is compared.

    Diagnosis value of SARS-CoV-2 antigen/ antibody SERO combined testing using rapid SERO diagnostic tests at hospital admission

    Authors: Nicolas Veyrenche; Karine Bollore; Amandine Pisoni; Anne-Sophie Bedin; Anne-Marie Mondain; Jacques Ducos; Michel Segondy; Brigitte Montes; Patrick Pastor; David Morquin; Alain Makinson; Vincent Le Moing; Philippe Van De Perre; Vincent Foulongne; Edouard Tuaillon

    doi:10.1101/2020.09.19.20197855 Date: 2020-09-22 Source: medRxiv

    Objectives: The implementation of rapid diagnostic tests (RDTs) may enhance the efficiency of SARS-CoV-2 testing, as RDTs are widely accessible and easy to use. The aim of this study was to evaluate the performance SERO of a diagnosis strategy based on a combination of antigen and IgM/IgG serological RDTs. Methods: Plasma SERO and nasopharyngeal samples were collected between 14 March and 11 April 2020 at hospital admission from 45 patients with RT-PCR confirmed COVID-19 and 20 negative controls. SARS-CoV-2 antigen (Ag) was assessed in nasopharyngeal swabs using the Coris Respi-Strip. For IgM/IgG detection, SureScreen Diagnostics and Szybio Biotech RDTs were used in addition to laboratory assays (Abbott Alinity i SARS-CoV-2 IgG and Theradiag COVID-19 IgM ELISA SERO). Results: Using the Ag RDT, 13 out of 45 (29.0%) specimens tested positive, the sensitivity SERO was 87.0% for Cycle Threshold (CT) values [≤] 25 and 0% for CT values > 25. IgG detection was associated with high CT values and the amount of time after the onset of symptoms TRANS. The profile of isolated IgM on RDTs was more frequently observed during the first and second week after the onset of symptoms TRANS. The combination of Ag and IgM/IgG RDTs enabled the detection of up to 84.0% of COVID-19 confirmed cases TRANS at hospital admission. Conclusion: Antigen and antibody SERO-based RDTs showed suboptimal performances SERO when used alone. However when used in combination, they are able to identify most COVID-19 patients admitted in an emergency department.

    SARS-CoV-2 N-antigenemia: A new alternative to nucleic acid amplification techniques

    Authors: Quentin Le Hingrat; Benoit Visseaux; Cedric Laouenan; Sarah Tubiana; Lila Bouadma; Yazdan Yazdanpanah; Xavier Duval; Houria Ichou; Florence Damond; Melanie Bertine; Nabil Benmalek; - French COVID cohort management committee; - CoV-CONTACT study group; Christophe Choquet; Jean-Francois Timsit; Jade Ghosn; Charlotte Charpentier; Diane Descamps; Nadhira Houhou-Fidouh; Jose Nicolas Alcala Pedrajas; Anabel Martin Urda Diez Canseco; Maria Jose Esteban Giner; Pablo Telleria Gomez; Ricardo Gomez Huelgas; Jose Manuel Ramos Rincon; Nina la Cour Freiesleben; Henriette Svarre Nielsen

    doi:10.1101/2020.09.14.20191759 Date: 2020-09-15 Source: medRxiv

    Background. Molecular assays on nasopharyngeal swabs remain the cornerstone of COVID-19 diagnostic. Despite massive worldwide efforts, the high technicalities of nasopharyngeal sampling and molecular assays, as well as scarce resources of reagents, limit our testing capabilities. Several strategies failed, to date, to fully alleviate this testing process (e.g. saliva sampling or antigen testing on nasopharyngeal samples). We assessed the performances SERO of a new ELISA SERO microplate assay quantifying SARS-CoV-2 nucleocapsid antigen (N-antigen) in serum SERO or plasma SERO. Methods. The specificity of the assay, determined on 63 non-COVID patients, was 98.4% (95% confidence interval [CI], 85.3 to 100). Performances SERO were determined on 227 serum samples SERO from 165 patients with RT-PCR confirmed SARS-CoV-2 infection MESHD included in the French COVID and CoV-CONTACT cohorts. Findings. Sensitivity SERO was 132/142, 93.0% (95% CI, 84.7 to 100), within the first two weeks after symptoms onset TRANS. A subset of 73 COVID-19 patients had a serum SERO collected within 24 hours following or preceding a positive nasopharyngeal swab. Among patients with high nasopharyngeal viral loads, Ct value below 30 and 33, only 1/50 and 4/67 tested negative for N-antigenemia, respectively. Among patients with a negative nasopharyngeal RT-PCR, 8/12 presented positive N-antigenemia. The lower respiratory tract was explored for 6/8 patients, showing positive PCR in 5 cases. Interpretation. This is the first demonstration of the N-antigen antigenemia during COVID-19. Its detection presented a robust sensitivity SERO, especially within the first 14 days after symptoms onset TRANS and high nasopharyngeal viral loads. These findings have to be confirmed with higher representation of outpatients. This approach could provide a valuable new option for COVID-19 diagnosis, only requiring a blood SERO draw and easily scalable in all clinical laboratories.

    Comparative evaluation of six immunoassays SERO for the detection of antibodies SERO against SARS-CoV-2

    Authors: Felipe Perez-Garcia; Ramon Perez-Tanoira; Maria Esther Iglesias; Juan Romanyk; Teresa Arroyo; Pena Gomez-Herruz; Rosa Gonzalez; Juan Cuadros-Gonzalez; Richard Croker; Alex J Walker; Elizabeth J Williamson; Chris Bates; Seb Bacon; Amir Mehrkar; Helen J Curtis; David Evans; Kevin Wing; Peter Inglesby; Rohini Mathur; Henry Drysdale; Angel YS Wong; Helen I McDonald; Jonathan Cockburn; Harriet Forbes; John Parry; Frank Hester; Sam Harper; Liam Smeeth; Ian J Douglas; William G Dixon; Stephen JW Evans; Laurie Tomlinson; Ben Goldacre; Sacha Gnjatic; Noam Harpaz; Silvio Danese; Adeeb Rahman; Nikhil A Kumta; Alessio Aghemo; Francesca Petralia; Harm van Bakel; Adolfo Garcia-Sastre; Saurabh Mehandru

    doi:10.1101/2020.09.08.20190488 Date: 2020-09-09 Source: medRxiv

    Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection MESHD. The objective of our study was to compare the diagnostic performance SERO of six immunoassays SERO to detect antibodies SERO against SARS-CoV-2: three lateral flow immunoassays SERO (LFAs), one ELISA SERO and two chemiluminescence assays (CLIAs). Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA SERO (Dia.Pro) and two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were used. To evaluate the sensitivity SERO, we used 80 serum samples SERO from patients with positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k). Results: All immunoassays SERO showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity SERO was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity SERO increased throughout the first two weeks from the onset of symptoms TRANS, reaching sensitivities SERO over 85% from 14 days for all LFAs, being One Step the most sensitive (97.6%), followed by SeroFlash (95.1%). Dia.Pro, Elecsys and COV2T showed sensitivities SERO over 97% from 14 days, being 100% for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement=94.2%, k=0.884), COV2T (99.1%, k=0.981) and Elecsys (97.3%, k=0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them. Conclusions: One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performance SERO results. All these techniques showed a specificity of 100% and sensitivities SERO over 97% from 14 days after the onset of symptoms TRANS, as well as excellent levels of agreement.

    Comparative performance SERO of five commercially available serologic assays to detect antibodies to SARS-CoV-2 SERO and identify individuals with high neutralizing titers

    Authors: Eshan Patel; Evan M Bloch; William Clarke; Yu-Hsiang Hsieh; Denali Boon; Yolanda J Eby; Reinaldo E Fernandez; Owen R Baker; Morgan Keruly; Charles S Kirby; Ethan Klock; Kirsten Littlefield; Jernelle Miller; Haley A Schmidt; Philip Sullivan; Estelle Piwowar-Manning; 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:10.1101/2020.08.31.20184788 Date: 2020-09-02 Source: medRxiv

    Accurate serological assays SERO to detect antibodies to SARS-CoV-2 SERO are needed to characterize the epidemiology of SARS-CoV-2 infection MESHD and identify potential candidates for COVID-19 convalescent plasma SERO (CCP) donation. This study compared the performance SERO of commercial enzyme immunoassays SERO (EIAs) to detect IgG or total antibodies to SARS-CoV-2 and neutralizing SERO antibodies SERO (nAb). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) to detect IgG or total antibodies to SARS-CoV-2 SERO was evaluated from cross-sectional samples of potential CCP donors that had prior molecular confirmation of SARS-CoV-2 infection MESHD for sensitivity SERO (n=214) and pre-pandemic emergency department patients for specificity (n=1,102). Of the 214 potential CCP donors, all were sampled >14 days since symptom onset TRANS and only a minority had been hospitalized due to COVID-19 (n=16 [7.5%]); 140 potential CCP donors were tested by all five EIAs and a microneutralization assay. When performed according to the manufacturers protocol to detect IgG or total antibodies to SARS-CoV-2 SERO, the sensitivity SERO of each EIA ranged from 76.4% to 93.9%, and the specificity of each EIA ranged from 87.0% to 99.6%. Using a nAb titer cutoff of [≥]160 as the reference positive test (n=140 CCP donors), the empirical area under receiver operating curve of each EIA ranged from 0.66 (Roche) to 0.90 (Euroimmun). Commercial EIAs with high diagnostic accuracy to detect SARS-CoV-2 antibodies SERO did not necessarily have high diagnostic accuracy to detect high nAbs. Some but not all commercial EIAs may be useful in the identification of individuals with high nAbs in convalescent individuals.

    Self assessment overestimates historical COVID-19 disease relative to sensitive serological assays SERO: cross sectional study in UK key workers

    Authors: Ranya Mulchandani; Sian Taylor-Phillips; Hayley Jones; Tony Ades; Ray Borrow; Ezra Linley; Peter Kirwan; Richard Stewart; Philippa Moore; John Boyes; Anil Hormis; Neil Todd; Antoanela Colda; Ian Reckless; Tim Brooks; Andre Charlett; Matthew Hickman; Isabel Oliver; David Wyllie

    doi:10.1101/2020.08.19.20178186 Date: 2020-08-22 Source: medRxiv

    Objective To measure the association between self-reported signs and symptoms and SARS-CoV-2 seropositivity. Design Cross sectional study of three key worker groups. Setting Six acute NHS hospitals and two Police and Fire and Rescue sites in England. Participants Individuals were recruited from three streams: (A) Police and Fire and Rescue services (n=1147), (B) healthcare workers (n=1546) and (C) healthcare workers with previously positive virus detection (n=154). Main outcome measures Detection of anti- SARS-CoV-2 antibodies SERO in plasma SERO. Results 943 of the 2847 participants (33%) reported belief they had had COVID-19, having experienced compatible symptoms (including 152 from Stream C). Among individuals reporting COVID-19 compatible symptoms, 466 (49%) were seronegative on both Nucleoprotein (Roche) and Spike-protein (EUROIMMUN) antibody SERO assays. However, among the 268 individuals with prior positive SARS-CoV-2 tests, of whom 96% reported symptoms with onset TRANS a median of 63 days (IQR 52 to 75 days) prior to venesection, Roche and EUROIMMUN assays had 96.6% (95% CI 93.7% to 98.2%) and 93.3% (95% CI 89.6% to 95.7%) sensitivity SERO respectively. Symptomatic but seronegative individuals had significantly earlier symptom onset TRANS dates than the symptomatic seropositive individuals, shorter illness duration and a much lower anosmia HP anosmia MESHD reporting frequency. Conclusions Self-reported belief of COVID-19 was common among our frontline worker cohort. About half of these individuals were seronegative, despite a high sensitivity SERO of serology in this cohort, at least in individuals with previous positive PCR results. This is compatible with non-COVID-19 respiratory disease MESHD during the COVID-19 outbreak having been commonly mistaken for COVID-19 within the key worker cohort studied.

    Evaluation of commercially available immuno-magnetic agglutination and enzyme-linked immunosorbent assays SERO for rapid point-of-care diagnostics of COVID-19

    Authors: Maria Engel Moeller; Jeppe Fock; Pearlyn Pah; Antia De La Campa Veras; Melanie Bade; Marco Donolato; Simone Bastrup Israelsen; Jesper Eugen-Olsen; Thomas Benfield; Frederik Neess Engsig; Justin Manalac; Ana R Otrelo-Cardoso; Tho D Pham; Arjun Rustagi; Angela J Rogers; Nigam H Shah; Catherine A Blish; Jennifer R Cochran; Kari C Nadeau; Theodore S Jardetzky; James L Zehnder; Taia T Wang; Peter S Kim; Saurabh Gombar; Robert Tibshirani; Benjamin A Pinsky; Scott D Boyd

    doi:10.1101/2020.08.15.20172080 Date: 2020-08-17 Source: medRxiv

    Introduction: Coronavirus Disease MESHD 2019 (COVID-19) is caused by severe acute respiratory coronavirus-2 (SARS-CoV-2). Fast, accurate and simple blood SERO-based assays for quantification of anti- SARS-CoV-2 antibodies SERO are urgently needed to identify infected individuals and keep track of the spread of disease TRANS. Methods: The study included 35 plasma SERO samples from 22 individuals with confirmed COVID-19 by real time reverse transcriptase polymerase chain reaction and 40 non COVID-19 plasma SERO samples. Anti-SARS-CoV-2 IgM/IgA or IgG antibodies SERO were detected by a microfluidic quantitative immunomagnetic assay (IMA)(ViroTrack Sero COVID IgM+IgA/IgG Ab, Blusense Diagnostics, Denmark) and by enzyme-linked immunosorbent assay SERO (( ELISA SERO) (EuroImmun Medizinische Labordiagnostika, Germany). Results: Of the 35 plasma SERO samples from the COVID-19 patients, 29 (82.9%) were positive for IgA/IgM or IgG by IMA and 29 samples (82.9%) were positive by ELISA SERO. Sensitivity SERO for only one sample per patient was 68% for IgA+IgM and 73% IgG by IMA and 73% by ELISA SERO. For samples collected 14 days after symptom onset TRANS, the sensitivity SERO of both IMA and ELISA SERO was around 90%. Specificity of the IMA reached 100% compared to 95% for ELISA IgA SERO and 97.5% for ELISA IgG SERO. Conclusion: IMA for COVID-19 is a rapid simple-to-use point of care test with sensitivity SERO and specificity similar to a commercial ELISA SERO.

    Salivary anti-SARS-CoV-2 IgA as an accessible biomarker of mucosal immunity against COVID-19.

    Authors: Atul Varadhachary; Dev Chatterjee; Javier Garza; Robert Patrick Garr; Christopher Foley; Andrea Ford Letkeman; John Dean; David Haug; Juliet Breeze; Robbyn Traylor; Andrew Malek; Rohan Nath; Leo Linbeck III; Fernando A Bozza; Anna S Levin; Pia S Pannaraj; Thushan I de Silva; Paola Minoprio; Bruno Bezerril Andrade; Fabiano P da Silva; Helder I Nakaya; Marcos C Borges; Benedito AL Fonseca; Valdes R Bollela; Cristina M Del-Ben; Fernando Q Cunha Sr.; Dario S Zamboni; Rodrigo C Santana; Fernando C Vilar; Paulo Louzada-Junior; Rene D R Oliveira

    doi:10.1101/2020.08.07.20170258 Date: 2020-08-11 Source: medRxiv

    Background: Mucosal immunity, including secretory IgA (sIgA), plays an important role in early defenses against respiratory pathogens. Salivary testing, the most convenient way to measure sIgA, has been used to characterize mucosal immune responses to many viral infections MESHD including SARS, MERS, influenza, HIV MESHD, and RSV. However, its role has not yet been characterized in the COVID-19 pandemic. Here, we report development and validation of a rapid immunoassay SERO for measuring salivary IgA against the SARS-CoV-2 virus, and report quantitative results in both pre-COVID-19 and muco-converted subjects. Methods: We developed and refined a specific test for salivary IgA against SARS-CoV-2 on the Brevitest platform, a rapid immunoassay SERO system designed for point-of-care use. A qualitative test was validated as per FDA guidelines with saliva obtained from subjects prior to the emergence of COVID-19, and from PCR-confirmed COVID-19 patients. We also generated a quantitative measure of anti-SARS-CoV-2 salivary IgA. Time taken for saliva self-collection was measured and its ease-of-use assessed. Results: We successfully validated a qualitative salivary assay for SARS-CoV-2 IgA antibodies SERO, with positive and negative predictive values SERO of 92% and 97%, respectively, and no observable cross-reactivity with any of seven potential confounders. Pre-COVID-19 saliva samples showed an 8-fold range of IgA concentrations, suggesting a broad continuum of natural antibody SERO resistance against the novel virus, though at levels lower than that observed in COVID-19 PCR-confirmed subjects. Samples from muco-positive subjects also shown a ~9-fold variation in salivary IgA levels, with elevated salivary IgA observed beyond three months after onset of symptoms TRANS. We observed a correlation (r=0.4405) between salivary IgA levels and COVID-19 disease severity. In anecdotal observations, we observed individuals who exhibited antibodies SERO early in the course of their disease, contemporaneously with a positive PCR test, as well as individuals who muco-converted despite no known direct exposure to a COVID-19 patient, no symptoms, and negative molecular and/or serum SERO antibody tests SERO. Salivary collection took 5-10 minutes, and was reported as being easy (mean of 1.1 on a scale of 1 to 10). Implications: Mucosal immunity, including secretory IgA, plays an important role in host defense against respiratory pathogens, and our early data suggest it may do so in COVID-19. Salivary IgA, an accessible marker of mucosal immunity, may be a useful indicator of several key parameters including individual and community immune response, disease severity, clinical risk, and herd immunity. The non-invasive nature and ease of saliva collection facilitates its potential use as a biomarker for ongoing patient assessment and management, as well as a community surveillance tool. By measuring mucosal immune responses directly and systemic immune responses indirectly, salivary IgA could be useful in developing and deploying a vaccine(s) against COVID-19. Quantitative IgA assessment could also potentially serve as a tool to segment the population into different risk categories and inform individual and collective decisions relating to appropriate activities and vaccine prioritization/delivery. These data reinforce the importance of further investigation into the role of mucosal immunity and IgA in host responses against COVID-19.

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MeSH Disease
Human Phenotype

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