Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting
| Autor: | Eloise Williams, Sharon R Lewin, Seok Lim, Katherine Bond, Damian F. J. Purcell, Theo Karapanagiotidis, Douglas F Johnson, Suellen Nicholson, Kanta Subbarao, Tuyet Hoang, Benjamin P Howden, Mike Catton, Deborah A Williamson, Francesca L Mordant, Cheryll Sia |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Point-of-care testing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Pneumonia Viral serology Enzyme-Linked Immunosorbent Assay Antibodies Viral Serology Betacoronavirus COVID-19 Testing Neutralization Tests Internal medicine medicine Major Article Prevalence Humans Immunology and Allergy Serologic Tests Symptom onset Pandemics medicine.diagnostic_test business.industry Clinical Laboratory Techniques Reverse Transcriptase Polymerase Chain Reaction SARS-CoV-2 Australia COVID-19 neutralization Confidence interval Immunoglobulin A AcademicSubjects/MED00290 Infectious Diseases Specimen collection lateral flow Immunoassay Immunoglobulin G ELISA business Coronavirus Infections Algorithms |
| Zdroj: | The Journal of Infectious Diseases |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiaa467 |
| Popis: | Background Robust serological assays are essential for long-term control of the COVID-19 pandemic. Many recently released point-of-care (PoCT) serological assays have been distributed with little premarket validation. Methods Performance characteristics for 5 PoCT lateral flow devices approved for use in Australia were compared to a commercial enzyme immunoassay (ELISA) and a recently described novel surrogate virus neutralization test (sVNT). Results Sensitivities for PoCT ranged from 51.8% (95% confidence interval [CI], 43.1%–60.4%) to 67.9% (95% CI, 59.4%–75.6%), and specificities from 95.6% (95% CI, 89.2%–98.8%) to 100.0% (95% CI, 96.1%–100.0%). ELISA sensitivity for IgA or IgG detection was 67.9% (95% CI, 59.4%–75.6%), increasing to 93.8% (95% CI, 85.0%–98.3%) for samples >14 days post symptom onset. sVNT sensitivity was 60.9% (95% CI, 53.2%–68.4%), rising to 91.2% (95% CI, 81.8%–96.7%) for samples >14 days post symptom onset, with specificity 94.4% (95% CI, 89.2%–97.5%). Conclusions Performance characteristics for COVID-19 serological assays were generally lower than those reported by manufacturers. Timing of specimen collection relative to onset of illness or infection is crucial in reporting of performance characteristics for COVID-19 serological assays. The optimal algorithm for implementing serological testing for COVID-19 remains to be determined, particularly in low-prevalence settings. Performance characteristics for COVID-19 serological assays were generally lower than those reported by manufacturers. The optimal algorithm for implementing serological testing for COVID-19 remains to be determined, particularly in low-prevalence settings where positive predictive values are low. |
| Databáze: | OpenAIRE |
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