#Performance Characteristics of the Abbott Architect #SARS-CoV-2 #IgG #Assay and #Seroprevalence in #Boise, #Idaho (J Clin Microbiol., abstract)

[Source: Journal of Clinical Microbiology, full page: (LINK). Abstract, edited.]

Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho

Andrew Bryan, Gregory Pepper, Mark H. Wener, Susan L. Fink, Chihiro Morishima, Anu Chaudhary, Keith R. Jerome, Patrick C. Mathias, Alexander L. Greninger

DOI: 10.1128/JCM.00941-20

 

ABSTRACT

Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous cases that were not tested for SARS-CoV-2 in February and March 2020, necessitating the use of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient populations. We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the United States and found one false positive, indicating a specificity of 99.90%. We tested 125 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specimens were available and found sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity. Alternative index value thresholds for positivity resulted in 100% sensitivity and 100% specificity in this cohort. We tested 4,856 individuals from Boise, Idaho collected over one week in April 2020 as part of the Crush the Curve initiative and detected 87 positives for a positivity rate of 1.79%. These data demonstrate excellent analytical performance of the Abbott SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States. We expect the availability of high-quality serological testing will be a key tool in the fight against SARS-CoV-2.

Copyright © 2020 Bryan et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

Keywords: SARS-CoV-2; COVID-19; Serology; Diagnostic tests; Seroprevalence; USA; Idaho.

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#Diagnostic #accuracy of an automated chemiluminescent #immunoassay for anti‐ #SARS‐CoV‐2 #IgM and #IgG #antibodies: an #Italian experience (J Med Virol., abstract)

[Source: Journal of Medical Virology, full page: (LINK). Abstract, edited.]

Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience

Maria Infantino,  Valentina Grossi,  Barbara Lari,  Riccardo Bambi,  Alessandro Perri, Matteo Manneschi,  Giovanni Terenzi,  Irene Liotti,  Giovanni Ciotta,  Cristina Taddei, Maurizio Benucci,  Patrizia Casprini,  Francesca Veneziani,  Sergio Fabbri,  Adolfo Pompetti,  Mariangela Manfredi

First published: 24 April 2020 | DOI:  https://doi.org/10.1002/jmv.25932

 

Abstract

A pandemic of coronavirus disease 2019 (COVID‐19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID‐19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID‐19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty‐one COVID‐19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti‐SARS CoV‐2 antibodies IgM and IgG. All COVID‐19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reverse‐transcription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer’s cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti‐SARS CoV‐2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti‐SARS‐CoV‐2 antibodies profile and can be considered an excellent tool for COVID‐19 diagnostics.

Keywords: SARS-CoV-2; COVID-19; Serology; Diagnostic tests; Italy.

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A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for #Serological #Diagnosis of #Coronavirus Disease 2019 (#COVID19) (J Infect Dis., abstract)

[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]

A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Coronavirus Disease 2019 (COVID-19)

Xue-fei Cai, Juan Chen, Jie-li Hu, Quan-xin Long, Hai-jun Deng, Kai Fan, Pu Liao, Bei-zhong Liu, Gui-cheng Wu, Yao-kai Chen, Zhi-jie Li, Kun Wang, Xiao-li Zhang, Wen-guang Tian, Jiang-lin Xiang, Hong-xin Du, Jing Wang, Yuan Hu, Ni Tang, Yong Lin, Ji-hua Ren, Lu-yi Huang, Jie Wei, Chun-yang Gan, Yan-meng Chen, Qing-zhu Gao, A-mei Chen, Chang-long He, Dao-Xin Wang, Peng Hu, Fa-Chun Zhou, Ai-long Huang, Ping Liu, De-qiang Wang

The Journal of Infectious Diseases, jiaa243, https://doi.org/10.1093/infdis/jiaa243

Published: 08 May 2020

 

Abstract

SARS-CoV-2, a novel ß-coronavirus, cause severe pneumonia and has spread throughout the globe rapidly. The disease associated with SARS-CoV-2 infection is named COVID-19. To date, real-time RT-PCR is the only test able to confirm this infection. However, the accuracy of RT-PCR depends on several factors; variations in these factors might significantly lower the sensitivity of detection. Here, we developed a peptide-based luminescent immunoassay that detected immunoglobulin G (IgG) and IgM. The assay cut-off value was determined by evaluating the sera from healthy and infected patients for pathogens other than SARS-CoV-2. To evaluate assay performance, we detected IgG and IgM in the sera from confirmed patients. The positive rate of IgG and IgM was 71.4% and 57.2%, respectively. Therefore, combining our immunoassay with real-time RT-PCR might enhance the diagnostic accuracy of COVID-19.

SARS-CoV-2, COVID-19, Serological Test, chemiluminescence immunoassay

Issue Section: Major Article

This content is only available as a PDF.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Keywords: SARS-CoV-2; COVID-19; Serology; Diagnostic tests.

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A Peptide-based Magnetic Chemiluminescence Enzyme #Immunoassay for #Serological #Diagnosis of #Coronavirus Disease 2019 (#COVID19) (J Infect Dis., abstract)

[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]

A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Coronavirus Disease 2019 (COVID-19)

Xue-fei Cai, Juan Chen, Jie-li Hu, Quan-xin Long, Hai-jun Deng, Kai Fan, Pu Liao, Bei-zhong Liu, Gui-cheng Wu, Yao-kai Chen, Zhi-jie Li, Kun Wang, Xiao-li Zhang, Wen-guang Tian, Jiang-lin Xiang, Hong-xin Du, Jing Wang, Yuan Hu, Ni Tang, Yong Lin, Ji-hua Ren, Lu-yi Huang, Jie Wei, Chun-yang Gan, Yan-meng Chen, Qing-zhu Gao, A-mei Chen, Chang-long He, Dao-Xin Wang, Peng Hu, Fa-Chun Zhou, Ai-long Huang, Ping Liu, De-qiang Wang

The Journal of Infectious Diseases, jiaa243, https://doi.org/10.1093/infdis/jiaa243

Published: 08 May 2020

 

Abstract

SARS-CoV-2, a novel ß-coronavirus, cause severe pneumonia and has spread throughout the globe rapidly. The disease associated with SARS-CoV-2 infection is named COVID-19. To date, real-time RT-PCR is the only test able to confirm this infection. However, the accuracy of RT-PCR depends on several factors; variations in these factors might significantly lower the sensitivity of detection. Here, we developed a peptide-based luminescent immunoassay that detected immunoglobulin G (IgG) and IgM. The assay cut-off value was determined by evaluating the sera from healthy and infected patients for pathogens other than SARS-CoV-2. To evaluate assay performance, we detected IgG and IgM in the sera from confirmed patients. The positive rate of IgG and IgM was 71.4% and 57.2%, respectively. Therefore, combining our immunoassay with real-time RT-PCR might enhance the diagnostic accuracy of COVID-19.

SARS-CoV-2, COVID-19, Serological Test, chemiluminescence immunoassay

Issue Section: Major Article

This content is only available as a PDF.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Keywords: SARS-CoV-2; COVID-19; Serology; Diagnostic tests.

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Evaluation of commercial and automated #SARS-CoV-2 #IgG and #IgA #ELISAs using #coronavirus disease (#COVID19) patient samples (Euro Surveill., abstract)

[Source: Eurosurveillance, full page: (LINK). Abstract, edited.]

Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples

Anne J Jääskeläinen1, Eliisa Kekäläinen1, Hannimari Kallio-Kokko1, Laura Mannonen1, Elisa Kortela2, Olli Vapalahti1, Satu Kurkela1,3, Maija Lappalainen1,3

Affiliations: 1 Department of Virology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; 2 Infectious diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; 3 These authors contributed equally to the work

Correspondence:  Anne J Jääskeläinen

Citation style for this article: Jääskeläinen Anne J, Kekäläinen Eliisa, Kallio-Kokko Hannimari, Mannonen Laura, Kortela Elisa, Vapalahti Olli, Kurkela Satu, Lappalainen Maija. Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples. Euro Surveill. 2020;25(18):pii=2000603. https://doi.org/10.2807/1560-7917.ES.2020.25.18.2000603

Received: 12 Apr 2020;   Accepted: 07 May 2020

 

Abstract

Antibody-screening methods to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) need to be validated. We evaluated SARS-CoV-2 IgG and IgA ELISAs in conjunction with the EUROLabworkstation (Euroimmun, Lübeck, Germany). Overall specificities were 91.9% and 73.0% for IgG and IgA ELISAs, respectively. Of 39 coronavirus disease patients, 13 were IgG and IgA positive and 11 IgA alone at sampling. IgGs and IgAs were respectively detected at a median of 12 and 11 days after symptom onset.

©  This work is licensed under a Creative Commons Attribution 4.0 International License.

Keywords: SARS-CoV-2; COVID-19; Serology; Diagnostic tests.

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The #Ethics of #COVID19 #Immunity-Based #Licenses (“Immunity #Passports”) (JAMA, summary)

[Source: JAMA, full page: (LINK). Summary, edited.]

The Ethics of COVID-19 Immunity-Based Licenses (“Immunity Passports”)

Govind Persad, JD, PhD1; Ezekiel J. Emanuel, MD, PhD2

Author Affiliations: 1 Sturm College of Law, University of Denver, Denver, Colorado; 2 Department of Medical Ethics and Health Policy, Perelman School of Medicine,  Department of Healthcare Management, The Wharton School, University of  Pennsylvania, Philadelphia

JAMA. Published online May 6, 2020. doi:10.1001/jama.2020.8102

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Chile, Germany, and the UK, among others, have indicated they will implement certifications that a person has contracted and recovered from coronavirus disease 2019 (COVID-19) or, in the future, has received a COVID-19 vaccine. Such policies have been discussed, but not implemented, in the US. However, if other countries require these certifications for entrance, the US may adopt them to enable travel, generating calls to use them more broadly. Certifications of immunity are sometimes called “immunity passports” but are better conceptualized as immunity-based licenses. Such policies raise important questions about fairness, stigma, and counterproductive incentives but could also further individual freedom and improve public health.

(…)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

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#Privileges and #Immunity #Certification During the #COVID19 Pandemic (JAMA, summary)

[Source: JAMA, full page: (LINK). Summary, edited.]

Privileges and Immunity Certification During the COVID-19 Pandemic

Mark A. Hall, JD1; David M. Studdert, LLB, ScD2

Author Affiliations: 1 Wake Forest University Schools of Law and Medicine, Winston-Salem, North Carolina; 2 Stanford University Schools of Law and Medicine, Stanford, California

JAMA. Published online May 6, 2020. doi:10.1001/jama.2020.7712

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As the coronavirus disease 2019 (COVID-19) crisis enters its next phase, attention turns to the widespread testing programs needed to resume and maintain normal life activities.1 Effective prevention and surveillance require testing for active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and for antibodies that indicate prior infection and potential immunity.2 There is an established approach for infected individuals: mild cases self-isolate; and severe cases receive treatment. But what is the appropriate response for people with positive antibody tests?

(…)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

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