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      Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDI TM enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma

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          Highlights

          • Head-to-head comparison of the fully-automated Elecsys® Anti-SARS-CoV-2.

          • with the EDI TM IgM and IgG ELISAs for the detection of SARS-CoV-2 antibodies.

          • Antibodies were measured in COVID-19 patients, healthy blood donors and ICU patients.

          • Our findings indicate very high sensitivity/specificity for the Anti-SARS-CoV-2 assay.

          • We found acceptable agreement with the EDI TM IgM and IgG ELISAs.

          Abstract

          Background

          Here, we report on a head-to-head comparison of the fully-automated Elecsys® Anti-SARS-CoV-2 immunoassay with the EDI TM enzyme linked immunosorbent assays (ELISA) for the detection of SARS-CoV-2 antibodies in human plasma.

          Methods

          SARS-CoV-2 antibodies were measured with the Elecsys® assay and the EDI TM ELISAs (IgM and IgG) in 64 SARS-CoV-2 RT-PCR confirmed COVID-19 patients with serial blood samples (n=104) collected at different time points from symptom onset. Blood samples from 200 healthy blood donors and 256 intensive care unit (ICU) patients collected before the COVID-19 outbreak were also used.

          Results

          In COVID-19 patients, the percentage of positive results rose with time from symptom onset, peaking to positivity rates after 15-22 days of 100% for the Elecsys® assay, of 94% for the EDI TM IgM-ELISA and of 100% for the EDI TM IgG ELISA. In the 104 blood samples, the agreement between positive/negative classifications of the Elecsys® assay and the EDI TM ELISAs (IgM or IgG) was 90%. The false positivity rates in the healthy blood donors and the ICU patients were <1% for the Elecsys® assay and <3% for the EDI TM ELISAs.

          Conclusions

          Our results indicate a high sensitivity and specificity for the Elecsys® assay and an acceptable agreement with the EDI TM ELISAs.

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          Most cited references9

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          Antibody responses to SARS-CoV-2 in patients with COVID-19

          We report acute antibody responses to SARS-CoV-2 in 285 patients with COVID-19. Within 19 days after symptom onset, 100% of patients tested positive for antiviral immunoglobulin-G (IgG). Seroconversion for IgG and IgM occurred simultaneously or sequentially. Both IgG and IgM titers plateaued within 6 days after seroconversion. Serological testing may be helpful for the diagnosis of suspected patients with negative RT-PCR results and for the identification of asymptomatic infections.
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            Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019

            Abstract Background The novel coronavirus SARS-CoV-2 is a newly emerging virus. The antibody response in infected patient remains largely unknown, and the clinical values of antibody testing have not been fully demonstrated. Methods A total of 173 patients with SARS-CoV-2 infection were enrolled. Their serial plasma samples (n=535) collected during the hospitalization were tested for total antibodies (Ab), IgM and IgG against SARS-CoV-2. The dynamics of antibodies with the disease progress was analyzed. Results Among 173 patients, the seroconversion rate for Ab, IgM and IgG was 93.1%, 82.7% and 64.7%, respectively. The reason for the negative antibody findings in 12 patients might due to the lack of blood samples at the later stage of illness. The median seroconversion time for Ab, IgM and then IgG were day-11, day-12 and day-14, separately. The presence of antibodies was <40% among patients within 1-week since onset, and rapidly increased to 100.0% (Ab), 94.3% (IgM) and 79.8% (IgG) since day-15 after onset. In contrast, RNA detectability decreased from 66.7% (58/87) in samples collected before day-7 to 45.5% (25/55) during day 15-39. Combining RNA and antibody detections significantly improved the sensitivity of pathogenic diagnosis for COVID-19 (p<0.001), even in early phase of 1-week since onset (p=0.007). Moreover, a higher titer of Ab was independently associated with a worse clinical classification (p=0.006). Conclusions The antibody detection offers vital clinical information during the course of SARS-CoV-2 infection. The findings provide strong empirical support for the routine application of serological testing in the diagnosis and management of COVID-19 patients.
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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

                Contributors
                Journal
                Clin Chim Acta
                Clin. Chim. Acta
                Clinica Chimica Acta; International Journal of Clinical Chemistry
                Elsevier B.V.
                0009-8981
                1873-3492
                30 May 2020
                30 May 2020
                Affiliations
                [a ]Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria
                [b ]Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria
                [c ]Ludwig Boltzmann Institute for experimental and clinical traumatology Vienna, Vienna, Austria
                [d ]Department of Internal Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria
                [e ]Department of Clinical Pathology, Hospital of Bolzano, Bolzano, Italy
                Author notes
                [* ]Corresponding author.at: Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Seilerstaette 2-4, A-4020 Linz, Austria benjamin.dieplinger@ 123456bs-lab.at
                Article
                S0009-8981(20)30261-8
                10.1016/j.cca.2020.05.049
                7261064
                32485155
                6ded75e1-841b-45bf-938b-558488946fdf
                © 2020 Elsevier B.V. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 3 May 2020
                : 28 May 2020
                : 28 May 2020
                Categories
                Article

                Clinical chemistry
                covid-19,sars-cov-2,eclia,antibody testing,serological test
                Clinical chemistry
                covid-19, sars-cov-2, eclia, antibody testing, serological test

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