FDA Fact Sheet - Patients
FDA Fact Sheet - Health Care Providers
 
As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
 
Features/Benefits:
CLIA Waived
Rapid results in 10 minutes
Nasopharyngeal swab specimen collection
Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
 
Test Summary
Test Name:
Rapid Covid-19 Antigen Test
Alias:
Rapid Covid-19 Test; Covid-19 Antigen test 
Classification:
Authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
Methodology:
Lateral Flow Assay
Reference Range:
Not Detected
Result Interpretation: 
Positive (Detected) - results are indicative of an active infection with SARS-CoV-2 but does not rule out other bacterial infections or co-infection with other viruses.
Negative (Not Detected) - results indicate that SARS-CoV-2 was not detected in the specimen. However, a low level below the level of detection of SARS-CoV-2 could be possible. In addition, this result does not rule out the possibility of other bacterial infection or infection with other viruses.
Specimen (Preferred):
Nasopharyngeal Swab (dry)
Transport Temperature:
Frozen
Storage Condition:
Room Temperature - up to 4 hours in extraction buffer
-80 degrees Celsius - up to 5 days
Turn Around Time:
Standard - 15 minutes
 
FDA Emergency Use Authorization
This test has been authorized by the FDA under an EUA for use by authorized laboratories. The test has not been FDA cleared or approved. The test has been authorized only for the presence of antigens of SARS-CoV-2, not for any other viruses or pathogens. 
 
Note: $50.00 fee applied to returned payments.