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      Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

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          Abstract

          Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.

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          Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

          Background The ongoing outbreak of the recently emerged novel coronavirus (2019-nCoV) poses a challenge for public health laboratories as virus isolates are unavailable while there is growing evidence that the outbreak is more widespread than initially thought, and international spread through travellers does already occur. Aim We aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available. Methods Here we present a validated diagnostic workflow for 2019-nCoV, its design relying on close genetic relatedness of 2019-nCoV with SARS coronavirus, making use of synthetic nucleic acid technology. Results The workflow reliably detects 2019-nCoV, and further discriminates 2019-nCoV from SARS-CoV. Through coordination between academic and public laboratories, we confirmed assay exclusivity based on 297 original clinical specimens containing a full spectrum of human respiratory viruses. Control material is made available through European Virus Archive – Global (EVAg), a European Union infrastructure project. Conclusion The present study demonstrates the enormous response capacity achieved through coordination of academic and public laboratories in national and European research networks.
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            Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis

            Abstract The outbreak of the novel coronavirus disease (COVID‐19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS‐Cov‐2]) nucleic acid real‐time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations. In addition, high false‐negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point‐of‐care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID‐19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM‐IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS‐CoV‐2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.
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              Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19)

              Abstract Background The emergence of coronavirus disease 2019 (COVID-19) is a major healthcare threat. The current method of detection involves a quantitative polymerase chain reaction (qPCR)–based technique, which identifies the viral nucleic acids when present in sufficient quantity. False-negative results can be achieved and failure to quarantine the infected patient would be a major setback in containing the viral transmission. We aim to describe the time kinetics of various antibodies produced against the 2019 novel coronavirus (SARS-CoV-2) and evaluate the potential of antibody testing to diagnose COVID-19. Methods The host humoral response against SARS-CoV-2, including IgA, IgM, and IgG response, was examined by using an ELISA-based assay on the recombinant viral nucleocapsid protein. 208 plasma samples were collected from 82 confirmed and 58 probable cases (qPCR negative but with typical manifestation). The diagnostic value of IgM was evaluated in this cohort. Results The median duration of IgM and IgA antibody detection was 5 (IQR, 3–6) days, while IgG was detected 14 (IQR, 10–18) days after symptom onset, with a positive rate of 85.4%, 92.7%, and 77.9%, respectively. In confirmed and probable cases, the positive rates of IgM antibodies were 75.6% and 93.1%, respectively. The detection efficiency by IgM ELISA is higher than that of qPCR after 5.5 days of symptom onset. The positive detection rate is significantly increased (98.6%) when combining IgM ELISA assay with PCR for each patient compared with a single qPCR test (51.9%). Conclusions The humoral response to SARS-CoV-2 can aid in the diagnosis of COVID-19, including subclinical cases.
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                Author and article information

                Journal
                J Clin Med
                J Clin Med
                jcm
                Journal of Clinical Medicine
                MDPI
                2077-0383
                24 July 2020
                August 2020
                : 9
                : 8
                : 2369
                Affiliations
                [1 ]Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, 1205 Geneva, Switzerland; patrick.cohen@ 123456hcuge.ch (P.C.); sabine.yerly@ 123456hcuge.ch (S.Y.); Isabelle.Arm-Vernez@ 123456hcuge.ch (I.A.-V.); Pascale.Roux-Lombard@ 123456hcuge.ch (P.R.-L.); lionel.fontao@ 123456hcuge.ch (L.F.); claire-anne.siegrist@ 123456unige.ch (C.-A.S.); laurent.kaiser@ 123456hcuge.ch (L.K.); nicolas.vuilleumier@ 123456hcuge.ch (N.V.)
                [2 ]Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland; lena.mazza@ 123456hcuge.ch (L.M.); adrien.calame@ 123456hcuge.ch (A.C.); Isabella.Eckerle@ 123456hcuge.ch (I.E.)
                [3 ]Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, 1211 Geneva, Switzerland; benjamin.meyer@ 123456unige.ch
                [4 ]Department of Microbiology and Molecular Medicine, University of Geneva, 1211 Geneva, Switzerland; giulia.torriani@ 123456unige.ch
                [5 ]Division and Department of Primary Care Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland; idriss.guessous@ 123456hcuge.ch (I.G.); Silvia.Stringhini@ 123456hcuge.ch (S.S.)
                [6 ]Unit of Population Epidemiology, Division of Primary Care, Geneva University Hospitals, 1205 Geneva, Switzerland
                [7 ]Division of Immunology and Allergy, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland
                [8 ]Division of Dermatology, Geneva University Hospitals, 1205 Geneva, Switzerland
                [9 ]Division of General Internal Medicine, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland; Thomas.Agoritsas@ 123456hcuge.ch (T.A.); jerome.stirnemann@ 123456hcuge.ch (J.S.); jean-luc.reny@ 123456hcuge.ch (J.-L.R.)
                [10 ]Department of Childhood and Adolescence, Geneva University Hospitals, 1205 Geneva, Switzerland
                [11 ]Geneva Centre for Emerging Viral Diseases, Geneva University Hospitals and Faculty of Medicine, University of Geneva, 1205 Geneva, Switzerland
                Author notes
                [* ]Correspondence: diego.andrey@ 123456hcuge.ch
                [†]

                Contributed equally to corresponding author.

                Author information
                https://orcid.org/0000-0003-3247-9274
                https://orcid.org/0000-0003-0601-3550
                https://orcid.org/0000-0001-9964-4452
                https://orcid.org/0000-0001-7984-8669
                Article
                jcm-09-02369
                10.3390/jcm9082369
                7463984
                32722191
                f4df294c-ae62-4900-b8d0-3ca4e50b8070
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 29 June 2020
                : 21 July 2020
                Categories
                Article

                sars-cov-2,covid-19,igm/igg serology,rapid test,immunofluorescence,elisa

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