Diagnostic testing for SARS-CoV-2 is intended to identify current infection in individuals and is performed when a person has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent known or suspected exposure to SARS-CoV-2. Examples of diagnostic testing include testing symptomatic persons, testing persons identified through contact tracing efforts, and testing those who indicate that they were exposed to someone with a confirmed or suspected case of COVID-19
| Result Summary | ||
|---|---|---|
| Viruses | ||
| Not Detected | Adenovirus | |
| Not Detected | Coronavirus 229E | |
| Not Detected | Coronavirus HKU1 | |
| Not Detected | Coronavirus NL63 | |
| Not Detected | Coronavirus OC43 | |
| Not Detected | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | |
| Not Detected | Human Metapneumovirus | |
| ✓ | Detected | Human Rhinovirus/Enterovirus |
| Not Detected | Influenza A | |
| Not Detected | Influenza B | |
| Not Detected | Parainfluenza Virus 1 | |
| Not Detected | Parainfluenza Virus 2 | |
| ✓ | Detected | Parainfluenza Virus 3 |
| Not Detected | Parainfluenza Virus 4 | |
| Not Detected | Respiratory Syncytial Virus | |
| Bacteria | ||
| Not Detected | Bordetella parapertussis (IS1001) | |
| Not Detected | Bordetella pertussis (ptxP) | |
| Not Detected | Chlamydia pneumoniae | |
| Not Detected | Mycoplasma pneumoniae | |
Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV). The FDA has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2.
Antigen tests are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. Antigen tests are currently authorized to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent. The currently authorized antigen tests are not restricted to use on persons of a certain age.
Antigen tests are relatively inexpensive and can be used at the point-of-care. The currently authorized devices return results in approximately 15 minutes. Antigen tests for SARS-CoV-2 are generally less
sensitive than viral tests that detect nucleic acid using reverse transcription polymerase chain reaction (RT-PCR). See Proper interpretation of antigen test results is important for accurate clinical management of patients with suspected COVID-19, or for identification of potentially infected persons when used for screening.
The clinical performance of rapid antigen diagnostic tests largely depends on the circumstances in which they are used. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate setting like nursing homes, offices, schools etc. in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is required.
There are limited data to guide the use of rapid antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a previously confirmed case is still infectious.
| RT-PCR Tests | Antigen Tests | |
|---|---|---|
| Intended use | Detect current infection | Detect current infection |
| Analyte Detected | Viral RNA | Varal Antigens |
| Specimen Type(s) | Nasal Swab, Sputum, Saliva | Nasal Swab |
| Sensitivity | High | Moderate |
| Specificity | High | High |
| Test Complexity | Varies | Relatively easy to use |
| Authorized for Use at the Point-of-Care | Most devices are not, some devices are | Yes |
| Turnaround Time | Ranges from 15 minutes to > 2days | Approximately 15 minutes |
| Cost/Test | Moderate | Low |
Compassionate, Personalized Home Care You Can Trust. Rest easy knowing your loved one is receiving the exceptional care they truly deserve.
Licensed – Insured – Bonded – Accredited