Clinical Validity of Serum Antibodies to SARS-CoV-2
| العنوان: | Clinical Validity of Serum Antibodies to SARS-CoV-2 |
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| المؤلفون: | Caturegli, Giorgio, Materi, Joshua, Howard, Brittney M., Caturegli, Patrizio |
| المصدر: | Annals of Internal Medicine |
| بيانات النشر: | American College of Physicians, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, SARS-CoV-2, viruses, fungi, Pneumonia, Viral, COVID-19, Enzyme-Linked Immunosorbent Assay, Middle Aged, Antibodies, Viral, respiratory tract diseases, body regions, Betacoronavirus, Case-Control Studies, Humans, Female, skin and connective tissue diseases, Coronavirus Infections, Pandemics, Original Research, Retrospective Studies |
| الوصف: | Serum antibodies develop upon infection with SARS-CoV-2 and are currently used to stratify donors of convalescent plasma and assess the prevalence of COVID-19. This study examines the use of serum antibodies to SARS-CoV-2 spike protein in the diagnosis of COVID-19. Background: The clinical utility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies remains undefined. Objective: To determine the clinical validity and utility of SARS-CoV-2 antibodies. Design: Case–control study. Setting: First month of testing for coronavirus disease 2019 (COVID-19) by using a nucleic acid amplification test (NAAT) on nasopharyngeal swabs at the Johns Hopkins Hospital, Baltimore, Maryland (11 066 persons). Participants: Of the 11 066 tested persons, 115 (1%) were hospitalized adults investigated for COVID-19. Clinical record review was performed to classify them into a COVID-19 case group (n = 60) or a non–COVID-19 control group (n = 55). The laboratory control groups comprised 513 persons not tested by NAAT: 160 healthy laboratory employees, 101 persons positive for IgG antibodies against Epstein-Barr virus capsid antigen, 215 positive for thyroperoxidase antibody, and 37 positive for rheumatoid factor. Measurements: Serum IgG and IgA antibodies against SARS-CoV-2 spike protein were detected by using enzyme-linked immunosorbent assay. Results: Sensitivity and specificity of the SARS-CoV-2 IgG assay were 0.976 (95% CI, 0.928 to 0.995) and 0.988 (CI, 0.974 to 0.995), respectively, when performed 14 days or later after symptom onset, but sensitivity decreased at earlier time points. Immunoglobulin G developed rapidly and was sustained at high levels throughout follow-up (up to 58 days). Antibodies to SARS-CoV-2 predicted the odds of developing acute respiratory distress syndrome, which increased by 62% (CI, 48% to 81%; P < 0.001) for every 2-fold increase in IgG. Of 11 066 NAAT-tested patients, 457 were repeatedly NAAT-negative, and serum samples were obtained for 18 such patients: 6 COVID-19 case patients and 12 non–COVID-19 control patients. Antibodies were present in 5 of 6 case patients and none of the 12 control patients (P = 0.001). Limitations: The study was retrospective and performed at a single-center; the sample was small; follow-up was limited; and selection bias may have occurred. Conclusion: Antibodies to SARS-CoV-2 demonstrate infection when measured at least 14 days after symptom onset, associate with clinical severity, and provide valuable diagnostic support in patients who test negative by NAAT but remain clinically suspicious for COVID-19. Primary Funding Source: Clinical Immunology Laboratory, Department of Pathology, Johns Hopkins Hospital. |
| اللغة: | English |
| تدمد: | 1539-3704 0003-4819 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=pmid________::90875fe754ef2fcd100b86ccd31f9540Test http://europepmc.org/articles/PMC7370852Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.pmid..........90875fe754ef2fcd100b86ccd31f9540 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15393704 00034819 |
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