Corpus overview


Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    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.

    Prognostic value of sTREM-1 in COVID-19 patients: a biomarker for disease severity and mortality

    Authors: Pedro V da Silva Neto; Jonatan C S de Carvalho; Vinicius E Pimentel; Malena M Perez; Ingryd Carmona-Garcia; Nicola T Neto; Diana M Toro; Camilla N S Oliveira; Thais F C Fraga-Silva; Cristiane M Milanezi; Lilian C Rodrigues; Cassia F. S. L. Dias; Ana C Xavier; Giovanna S Porcel; Isabelle C Guarneri; Kamila Zaparoli; Caroline T Garbato; Jamille G M Argolo; Angelo A F Junior; Alessandro P de Amorim; Augusto M Degiovani; Dayane P da Silva; Debora C Nepomuceno; Rafael C da Silva; Leticia F Constant; Fatima M Ostini; Marley R Feitosa; Rogerio S Parra; Fernando C Vilar; Gilberto G Gaspar; Jose J R da Rocha; Omar Feres; Rita C C Barbieri; Fabiani G Frantz; Sandra R Maruyama; Elisa M S Russo; Angelina L Viana; Ana P M Fernandes; Isabel K F M Santos; Vania L D Bonato; Marcelo Dias-Baruffi; Adriana Malheiro; Ruxana T Sadikot; Cristina R B Cardoso; Lucia H Faccioli; Carlos A Sorgi

    doi:10.1101/2020.09.22.20199703 Date: 2020-09-23 Source: medRxiv

    Background: The uncontrolled inflammatory response plays a critical role in the novel coronavirus disease MESHD (COVID-19) and triggering receptor expressed on myeloid cells-1 (TREM-1) is thought to be intricate to inflammatory signal amplification. This study aims to investigate the association between soluble TREM-1 (sTREM-1) and COVID-19 as a prognostic biomarker to predict the disease severity, lethality and clinical management.Methods: We enrolled 91 patients with COVID-19 in domiciliary care (44 patients) or in hospital care (47 patients), who were classified after admission into mild, moderate, severe and critical groups according to their clinical scores. As non-COVID-19 control, 30 healthy volunteers were included. Data on demographic, comorbidities and baseline clinical characteristics were obtained from their medical and nurse records. Peripheral blood SERO samples were collected at admission and after hospitalization outcome to assess cytokine profile and sTREM-1 level by specific immunoassays SERO Results: Within COVID-19 patients, the highest severity was associated with the most significant elevated plasma SERO levels sTREM-1. Using receiver operating curve analysis (ROC), sTREM-1 was found to be predictive of disease severity (AUC= 0.988) and the best cut-off value for predicting in-hospital severity was [≥] 116.5 pg/mL with the sensitivity SERO for 93.3% and specificity for 95.8%. We also described the clinical characteristics of these patients and explored the correlation with markers of the disease aggravation. The levels of sTREM-1 were positively correlated with IL-6, IL-10, blood SERO neutrophils counts, and critical disease MESHD scoring (r= 0.68, p<0.0001). On the other hand, sTREM-1 level was significantly negative correlated with lymphocytes counting, and mild disease (r= -0.42, p<0.0001). Higher levels of sTREM-1 were related to poor outcome and death MESHD, patients who received dexamethasone tended to have lower sTREM-1 levels. Conclusion: Our results indicated that sTREM-1 in COVID-19 is associated with severe disease development and a prognostic marker for mortality. The use of severity biomarkers such as sTREM-1 together with patients clinical scores could improve the early recognition and monitoring of COVID-19 cases with higher risk of disease worsening. Key words: COVID-19; sTREM-1; Inflammation; Biomarker; Severity; Mortality.

    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.

    Distinct SARS-CoV-2 Antibody SERO Reactivity Patterns in Coronavirus Convalescent Plasma SERO Revealed by a Coronavirus Antigen Microarray

    Authors: Rafael Ramiro de Assis; Aarti Jain; Rie Nakajima; Algis Jasinskas; Saahir Khan; Larry J Dumont; Kathleen Kelly; Graham Simmons; Mars Stone; Clara Di Germanio; Michael P Busch; Philip L Felgner

    doi:10.1101/2020.09.16.300871 Date: 2020-09-17 Source: bioRxiv

    A coronavirus antigen microarray (COVAM) was constructed containing 11 SARS-CoV-2, 5 SARS-1, 5 MERS, and 12 seasonal coronavirus recombinant proteins. The array is designed to measure immunoglobulin isotype and subtype levels in serum SERO or plasma SERO samples against each of the individual antigens printed on the array. We probed the COVAM with COVID-19 convalescent plasma SERO (CCP) collected from 99 donors who recovered from a PCR+ confirmed SARS-CoV-2 infection MESHD. The results were analyzed using two computational approaches, a generalized linear model (glm) and Random Forest (RF) prediction model, to classify individual specimens as either Reactive or Non-Reactive against the SARS-CoV-2 antigens. A training set of 88 pre-COVID-19 specimens (PreCoV) collected in August 2019 and 102 positive specimens from SARS-CoV-2 PCR+ confirmed COVID-19 cases was used for these analyses. Results compared with an FDA emergency use authorized (EUA) SARS-CoV2 S1-based total Ig chemiluminescence immunoassay SERO (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and with a SARS-CoV-2 S1-S2 spike-based pseudovirus micro neutralization assay (SARS-CoV-2 reporter viral particle neutralization titration (RVPNT) showed high concordance between the 3 assays. Three CCP specimens that were negative by the VITROS CoV2T immunoassay SERO were also negative by both COVAM and the RVPNT assay. Concordance between VITROS CoV2T and COVAM was 96%, VITROS CoV2T and RVPNT 93%, and RVPNT and COVAM 95%. The discordances were all weakly reactive samples near the cutoff threshold of the VITROS CoV2T immunoassay SERO. The multiplex COVAM allows CCP to be grouped according to antibody SERO reactivity patterns against 11 SARS-CoV-2 antigens. Unsupervised K-means analysis, via the gap statistics, as well as hierarchical clustering analysis revealed 3 main clusters with distinct reactivity intensities and patterns. These patterns were not recapitulated by adjusting the VITROS CoV2T or RVPNT assay thresholds. Plasma SERO classified according to these reactivity patterns may be better associated with CCP treatment efficacy than antibody SERO levels alone. The use of a SARS-CoV-2 antigen array may be useful to qualify CCP for administration as a treatment for acute COVID-19 and to interrogate vaccine immunogenicity and performance SERO in preclinical and clinical studies to understand and recapitulate antibody SERO responses associated with protection from infection and disease.

    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.

    Development, clinical translation, and utility of a COVID-19 antibody test SERO with qualitative and quantitative readouts

    Authors: Robert H. Bortz III; Catalina Florez; Ethan Laudermilch; Ariel S Wirchnianski; Gorka Lasso; Ryan J Malonis; George I Georgiev; Olivia Vergnolle; Natalia G Herrera; Nicholas C Morano; Sean T Campbell; Erika P. Orner; Amanda Mengotto; M Eugenia Dieterle; Jens Maximilian Fels; Denise Haslwanter; Rohit Jangra; Alev Celikgil; Duncan Kimmel; James H Lee; Margarette Mariano; Antonio Nakouzi; Jose Quiroz; Johanna Rivera; Wendy A Szymczak; Karen Tong; Jason Barnhill; Mattias NE Forsell; Clas Ahlm; Daniel T. Stein; Liise-anne Pirofski; Doctor Y Goldstein; Scott J. Garforth; Steven C. Almo; Johanna P. Daily; Michael B. Prystowsky; James D. Faix; Amy S. Fox; Louis M. Weiss; Jonathan R. Lai; Kartik Chandran

    doi:10.1101/2020.09.10.20192187 Date: 2020-09-11 Source: medRxiv

    The COVID-19 global pandemic caused by severe acute respiratory syndrome coronavirus-2 MESHD (SARS-CoV-2) continues to place an immense burden on societies and healthcare systems. A key component of COVID-19 control efforts is serologic testing SERO to determine the community prevalence SERO of SARS-CoV-2 exposure and quantify individual immune responses to prior infection MESHD or vaccination. Here, we describe a laboratory-developed antibody test SERO that uses readily available research-grade reagents to detect SARS-CoV-2 exposure in patient blood SERO samples with high sensitivity SERO and specificity. We further show that this test affords the estimation of viral spike-specific IgG titers from a single sample measurement, thereby providing a simple and scalable method to measure the strength of an individual's immune response. The accuracy, adaptability, and cost-effectiveness of this test makes it an excellent option for clinical deployment in the ongoing COVID-19 pandemic.

    Robust SARS-COV-2 serological population screens via multi-antigen rules-based approach

    Authors: Christos F Fotis; Nikolaos Meimetis; Nikos Tsolakos; Marianna Politou; Karolina Akinosoglou; Vicky Pliaka; Angeliki Minia; Evangelos Terpos; Ioannis P. Trougakos; Andreas Mentis; Markos Marangos; George Panayiotakopoulos; Meletios A. Dimopoulos; Charalampos Gogos; Alexandros Spyridonidis; Leonidas G. Alexopoulos

    doi:10.1101/2020.09.09.20191122 Date: 2020-09-10 Source: medRxiv

    More than 300 SARS-COV-2 serological tests SERO have recently been developed using either the nucleocapsid phosphoprotein (N), the spike glycoprotein subunit (S1), and more recently the receptor binding domain (RBD). Most of the assays report very good clinical performance SERO characteristics in well-controlled clinical settings. However, there is a growing belief that good performance SERO characteristics that are obtained during clinical performance SERO trials might not be sufficient to deliver good diagnostic results in population-wide screens that are usually characterized with low seroprevalence SERO. In this paper, we developed a serological assay SERO against N, S1 and RBD using a bead-based multiplex platform and a rules-based computational approach to assess the performance SERO of single and multi-antigen readouts in well-defined clinical samples and in a population-wide serosurvey from blood SERO donors. Even though assays based on single antigen readouts performed similarly well in the clinical samples, there was a striking difference between the antigens on the population-wide screen. Asymptomatic TRANS individuals with low antibody SERO titers and sub-optimal assay specificity might contribute to the large discrepancies in population studies with low seroprevalence SERO. A multi-antigen assay requiring partial agreement between RBD, N and S1 readouts exhibited enhanced specificity, less dependency on assay cut-off values and an overall more robust performance SERO in both sample settings. Our data suggest that assays based on multiple antigen readouts combined with a rules-based computational consensus can provide a more robust platform for routine antibody SERO screening.

    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.

    Antibody SERO Responses to SARS-CoV-2 in Coronavirus Diseases MESHD 2019 Patients with Different Severity

    Authors: Ekasit Kowitdamrong; Thanyawee Puthanakit; Watsamon Jantarabenjakul; Eakachai Prompetchara; Pintip Suchartlikitwong; Opass Putcharoen; Nattiya Hirankarn; Ke Lan; Yu Chen; Huabin Zhao

    doi:10.1101/2020.09.06.20189480 Date: 2020-09-08 Source: medRxiv

    Background: More understanding of antibody SERO responses in the SARS-CoV-2 infected MESHD population is useful for vaccine development. Aim: To investigate SARS-CoV-2 IgA MESHD and IgG among COVID-19 Thai patients with different severity. Methods: We used plasma SERO from 118 adult TRANS patients who have confirmed SARS-CoV-2 infection MESHD and 49 patients under investigation without infection MESHD, 20 patients with other respiratory infections MESHD, and 102 healthy controls. Anti-SARS-CoV-2 IgA and IgG were performed by enzyme-linked immunosorbent assay SERO from Euroimmun. The optical density ratio cut off for positive test was 1.1 for IgA and 0.8 for IgG. The association of antibody SERO response with the severity of diseases and the day of symptoms was performed. Results: From Mar 10 to May 31, 2020, 289 participants were enrolled, and 384 samples were analyzed. Patients were categorized by clinical manifestations to mild (n=59), moderate (n=27) and severe (n=32). The overall sensitivity SERO of IgA and IgG from samples collected after day 7 is 87.9% (95% CI 79.8-93.6) and 84.8% (95% CI 76.2-91.3), respectively. The severe group had a significantly higher level of specific IgA and IgG to S1 antigen compared to the mild group. All moderate to severe patients have specific IgG while 20% of the mild group did not have any IgG detected after two weeks. Interestingly, SARS-CoV-2 IgG level was significantly higher in males TRANS compared to females TRANS among the severe group (p=0.003). Conclusion: The serologic test SERO for SARS-CoV-2 has high sensitivity SERO after the second week after onset of illness. Serological response differs among patients with different severity and different sex.

    Clinical Performance SERO Evaluation of a SARS-CoV-2 Rapid Antibody Test SERO for Determining Past Exposure to SARS-CoV-2

    Authors: Peter Findeisen; Hugo Stiegler; Eloisa Lopez-Calle; Tanja Schneider; Eva Urlaub; Johannes Hayer; Claudia Silke Zemmrich

    doi:10.1101/2020.09.01.20180687 Date: 2020-09-04 Source: medRxiv

    The true prevalence SERO and population seropositivity of SARS-CoV-2 infection MESHD remains unknown, due to the number of asymptomatic TRANS infections MESHD and limited access to high- performance SERO antibody tests SERO. To control the COVID-19 pandemic it is crucial to understand the true seroprevalence SERO, but not every region has access to extensive centralized PCR and serology testing. Currently available rapid antibody tests SERO lack the accuracy needed for recommendation by health authorities. To fill this gap, we analyzed and validated the clinical performance SERO of a new point-of-care SARS-CoV-2 Rapid Antibody SERO Assay, a chromatographic immunoassay SERO for qualitative detection of IgM/IgG antibodies SERO for use in near-patient settings. Analysis was performed using 42 Anti-SARS-Cov-2 positive (CoV+) and 92 Anti-SARS-Covid-2 negative (CoV-) leftover samples from before December 2019, using the Elecsys(R) Anti-SARS-CoV-2 as the reference assay. Analytical specificity was tested using leftover samples from individuals with symptoms of common cold collected before December 2019. The SARS-CoV-2 Rapid Antibody Test SERO was 100.0% (95% CI 91.59-100.00) sensitive and 96.74% (95% CI 90.77-99.32) specific with an assay failure rate of 0.00%. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+/275 CoV- samples, also comparing whole blood SERO versus plasma SERO matrix. The comparison demonstrated for plasma SERO 96.00% positive/96.36% negative percent agreement with the Elecsys Anti-SARS-CoV-2 and overall 99.20% percent agreement between whole blood SERO and EDTA plasma SERO. The SARS-CoV-2 Rapid Antibody Test SERO demonstrated similar clinical performance SERO to the manufacturer's data and to a centralized automated immunoassay SERO, with no cross-reactivity to common cold panels.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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