Evaluation of Four Rapid Antigen Tests for Detection of SARS-CoV-2 virus
| Autor: | Intisar Al-Shukri, Hala Al-Hinai, Mohammed Al-Rashidi, Nawal Al-Kindi, Azza Al-Rashdi, Sulaiman Al-Alawi, Hanan Al-Kindi, Sachin Jose, Amina Al-Jardani |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Diagnostic Tests Routine business.industry Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Original Articles General Medicine Significant negative correlation Gastroenterology Virus law.invention reverse transcriptase polymerase chain reaction Reverse transcription polymerase chain reaction diagnostic tests routine covid-19 Antigen law Internal medicine FLUORESCENT IMMUNOASSAY medicine Medicine business Polymerase chain reaction |
| Zdroj: | Oman Medical Journal, Vol 36, Iss 5, Pp e297-e297 (2021) Oman Medical Journal |
| ISSN: | 2070-5204 1999-768X |
| DOI: | 10.5001/omj.2021.106 |
| Popis: | Objectives: Considering the increasing, significant burden that coronavirus disease 2019 (COVID-19) imposes on the healthcare system, the need for simple, rapid, and affordable diagnostic tests to support the existing costly and demanding polymerase chain reaction (PCR) assay becomes required. This prospective diagnostic test accuracy study aims to evaluate the performance of four different COVID-19 rapid antigen tests compared to real-time reverse transcription PCR (rRT-PCR) between June and July 2020 to determine the feasibility of integrating these tests into the diagnostic algorithm in clinical settings. Methods: Swabs were collected from 306 patients and analyzed using rRT-PCR and antigen tests from four different providers. Results: The antigen tests’ sensitivities were 65.8%, 69.8%, 64.0%, and 64.3% for the STANDARD™ Q COVID-19 Ag test, PCL COVID-19 Ag Rapid fluorescent immunoassay (FIA) test, BIOCREDIT COVID-19 Ag test, and Sofia SARS-CoV-2 antigen FIA test, respectively. Specificity was 94.1% for PCL COVID-19 Ag Rapid test and 100% for the other three assays. All assays showed a significant negative correlation between the reference rRT-PCR Ct values and Ag test results. Besides, sensitivities of the STANDARD™ Q COVID-19 Ag test, PCL COVID-19 Ag Rapid FIA test, and BIOCREDIT COVID-19 Ag test improved to ≥ 85% after exclusion of samples with PCR Ct values > 30. Conclusions: The high specificity of the rapid antigen tests and other parameters like simplicity, rapidity, and affordability suggest that antigen tests are likely to be helpful if integrated and interpreted appropriately in stepwise diagnostic algorithms. Given the low sensitivity of 64.0–69.8% of the antigen tests, we recommend that clinically relevant negative results undergo further testing Ag to confirm or exclude a COVID-19 diagnosis. |
| Databáze: | OpenAIRE |
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