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Temporal Course of SARS-CoV-2 Antibody Positivity in Patients with COVID-19 following the First Clinical Presentation.
Biomed Res Int. 2020; 2020:9878453.BR

Abstract

Knowledge of the sensitivities of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests beyond 35 days after the clinical onset of COVID-19 is insufficient. We aimed to describe positivity rate of SARS-CoV-2 assays employing three different measurement principles over a prolonged period. Two hundred sixty-eight samples from 180 symptomatic patients with COVID-19 and a reverse transcription polymerase chain reaction (RT-PCR) test followed by serological investigation of SARS-CoV-2 antibodies were included. We conducted three chemiluminescence (including electrochemiluminescence assay (ECLIA)), four enzyme-linked immunosorbent assay (ELISA), and one lateral flow immunoassay (LFIA) test formats. Positivity rates, as well as positive (PPVs) and negative predictive values (NPVs), were calculated for each week after the first clinical presentation for COVID-19. Furthermore, combinations of tests were assessed within an orthogonal testing approach employing two independent assays and predictive values were calculated. Heat maps were constructed to graphically illustrate operational test characteristics. During a follow-up period of more than 9 weeks, chemiluminescence assays and one ELISA IgG test showed stable positivity rates after the third week. With the exception of ECLIA, the PPVs of the other chemiluminescence assays were ≥95% for COVID-19 only after the second week. ELISA and LFIA had somewhat lower PPVs. IgM exhibited insufficient predictive characteristics. An orthogonal testing approach provided PPVs ≥ 95% for patients with a moderate pretest probability (e.g., symptomatic patients), even for tests with a low single test performance. After the second week, NPVs of all but IgM assays were ≥95% for patients with low to moderate pretest probability. The confirmation of negative results using an orthogonal algorithm with another assay provided lower NPVs than the single assays. When interpreting results from SARS-CoV-2 tests, the pretest probability, time of blood draw, and assay characteristics must be carefully considered. An orthogonal testing approach increases the accuracy of positive, but not negative, predictions.

Authors+Show Affiliations

Zentrallabor, Kantonsspital Graubünden, Loësstrasse 170, 7000 Chur, Switzerland.Liechtensteinisches Landesspital, Heiligkreuz, 9490 Vaduz, Liechtenstein.Liechtensteinisches Landesspital, Heiligkreuz, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein. Private Universität im Fürstentum Liechtenstein, Dorfstrasse, 9495 Triesen, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland.Labormedizinisches Zentrum Dr. Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland.Labormedizinisches Zentrum Dr. Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland.Centro Medicina di Laboratorio Dr. Risch, Via Arbostra 2, 6963 Pregassona, Switzerland.Clm Dr. Risch Arc Lémanique SA, Chemin de l'Esparcette 10, 1023 Crissier, Switzerland.Division of Infectious Diseases, Cantonal Hospital Chur, Loësstrasse 170, 7000 Chur, Switzerland.Division of Infectious Diseases, Cantonal Hospital Chur, Loësstrasse 170, 7000 Chur, Switzerland.Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg, University Hospital Giessen and Marburg, Baldingerstraβe, 35043 Marburg, Germany.Cantonal Hospital St. Gallen, Department of Infectious Diseases and Hospital Epidemiology, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland.Cantonal Hospital St. Gallen, Department of Infectious Diseases and Hospital Epidemiology, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland.Cantonal Hospital St. Gallen, Department of Infectious Diseases and Hospital Epidemiology, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland. Children's Hospital of Eastern Switzerland, Department of Infectious Diseases and Hospital Epidemiology, Claudiusstrasse 6, 9006 St. Gallen, Switzerland.Liechtensteinisches Landesspital, Heiligkreuz, 9490 Vaduz, Liechtenstein.Labormedizinisches Zentrum Dr. Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein. Private Universität im Fürstentum Liechtenstein, Dorfstrasse, 9495 Triesen, Liechtenstein. Center of Laboratory Medicine, University Institute of Clinical Chemistry, University of Bern, Inselspital, 3010 Bern, Switzerland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33224987

Citation

Risch, Martin, et al. "Temporal Course of SARS-CoV-2 Antibody Positivity in Patients With COVID-19 Following the First Clinical Presentation." BioMed Research International, vol. 2020, 2020, p. 9878453.
Risch M, Weber M, Thiel S, et al. Temporal Course of SARS-CoV-2 Antibody Positivity in Patients with COVID-19 following the First Clinical Presentation. Biomed Res Int. 2020;2020:9878453.
Risch, M., Weber, M., Thiel, S., Grossmann, K., Wohlwend, N., Lung, T., Hillmann, D., Ritzler, M., Ferrara, F., Bigler, S., Egli, K., Bodmer, T., Imperiali, M., Salimi, Y., Fleisch, F., Cusini, A., Renz, H., Kohler, P., Vernazza, P., ... Risch, L. (2020). Temporal Course of SARS-CoV-2 Antibody Positivity in Patients with COVID-19 following the First Clinical Presentation. BioMed Research International, 2020, 9878453. https://doi.org/10.1155/2020/9878453
Risch M, et al. Temporal Course of SARS-CoV-2 Antibody Positivity in Patients With COVID-19 Following the First Clinical Presentation. Biomed Res Int. 2020;2020:9878453. PubMed PMID: 33224987.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Temporal Course of SARS-CoV-2 Antibody Positivity in Patients with COVID-19 following the First Clinical Presentation. AU - Risch,Martin, AU - Weber,Myriam, AU - Thiel,Sarah, AU - Grossmann,Kirsten, AU - Wohlwend,Nadia, AU - Lung,Thomas, AU - Hillmann,Dorothea, AU - Ritzler,Michael, AU - Ferrara,Francesca, AU - Bigler,Susanna, AU - Egli,Konrad, AU - Bodmer,Thomas, AU - Imperiali,Mauro, AU - Salimi,Yacir, AU - Fleisch,Felix, AU - Cusini,Alexia, AU - Renz,Harald, AU - Kohler,Philipp, AU - Vernazza,Pietro, AU - Kahlert,Christian R, AU - Paprotny,Matthias, AU - Risch,Lorenz, Y1 - 2020/11/16/ PY - 2020/07/24/received PY - 2020/10/13/revised PY - 2020/10/22/accepted PY - 2020/11/23/entrez PY - 2020/11/24/pubmed PY - 2020/12/2/medline SP - 9878453 EP - 9878453 JF - BioMed research international JO - Biomed Res Int VL - 2020 N2 - Knowledge of the sensitivities of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests beyond 35 days after the clinical onset of COVID-19 is insufficient. We aimed to describe positivity rate of SARS-CoV-2 assays employing three different measurement principles over a prolonged period. Two hundred sixty-eight samples from 180 symptomatic patients with COVID-19 and a reverse transcription polymerase chain reaction (RT-PCR) test followed by serological investigation of SARS-CoV-2 antibodies were included. We conducted three chemiluminescence (including electrochemiluminescence assay (ECLIA)), four enzyme-linked immunosorbent assay (ELISA), and one lateral flow immunoassay (LFIA) test formats. Positivity rates, as well as positive (PPVs) and negative predictive values (NPVs), were calculated for each week after the first clinical presentation for COVID-19. Furthermore, combinations of tests were assessed within an orthogonal testing approach employing two independent assays and predictive values were calculated. Heat maps were constructed to graphically illustrate operational test characteristics. During a follow-up period of more than 9 weeks, chemiluminescence assays and one ELISA IgG test showed stable positivity rates after the third week. With the exception of ECLIA, the PPVs of the other chemiluminescence assays were ≥95% for COVID-19 only after the second week. ELISA and LFIA had somewhat lower PPVs. IgM exhibited insufficient predictive characteristics. An orthogonal testing approach provided PPVs ≥ 95% for patients with a moderate pretest probability (e.g., symptomatic patients), even for tests with a low single test performance. After the second week, NPVs of all but IgM assays were ≥95% for patients with low to moderate pretest probability. The confirmation of negative results using an orthogonal algorithm with another assay provided lower NPVs than the single assays. When interpreting results from SARS-CoV-2 tests, the pretest probability, time of blood draw, and assay characteristics must be carefully considered. An orthogonal testing approach increases the accuracy of positive, but not negative, predictions. SN - 2314-6141 UR - https://www.unboundmedicine.com/medline/citation/33224987/Temporal_Course_of_SARS_CoV_2_Antibody_Positivity_in_Patients_with_COVID_19_following_the_First_Clinical_Presentation_ L2 - https://doi.org/10.1155/2020/9878453 DB - PRIME DP - Unbound Medicine ER -