General Population Diagnostic
- Allows rapid examination
Hospitals, Physician Offices, Laboratories
- Can be use for a diagnostic of carriers who are asymptomatic
- Can help determine if patient recently affected by virus, even if virus is no longer present
*This test is only approved in a Point-of-Care setting
*CLIA Certificate of Waiver number required for purchase
Frequently Asked Questions
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.
The sensitivity of rapid antigen tests is generally lower than RT-PCR. The first antigen tests to have received FDA EUAs demonstrate sensitivity ranging from 84.0%-97.6% compared to RT-PCR.
Antigen levels in specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test. This may result in a negative test result, while a more sensitive test, such as RT-PCR, may return a positive result.
The specificity of rapid antigen tests is generally as high as RT-PCR – the first antigen tests that have received FDA EUAs have reported specificity of 100% – which means that false positive results are unlikely.
One type of rapid diagnostic test (RDT) detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from the respiratory tract of a person. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies fixed to a paper strip enclosed in a plastic casing and generate a visually detectable signal, typically within 30 minutes. The antigen(s) detected are expressed only when the virus is actively replicating; therefore, such tests are best used to identify acute or early infection.
COVID-19 Antigen Rapid Test Device
The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for then detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset
Features & Benefits
- Identify individual’s current infection status to COVID-19
- Fast and easy to use in Point-of-Care setting
- Qualitatively detect the SARS-CoV-2 nucleocapsid protein
- Use nasopharyngeal (NP) swab specimens
- Reliable results reads at 10 minutes
- No special equipment or training required
- All-in-one package including collection swabs
- High sensitivity (88.4%) and specificity (100%)
How it Works
- Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times.
- Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
- Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
- Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019-
EUAs:(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas