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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.



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


Rapid Covid-19 Test; Covid-19 Antigen test 


Authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.


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:


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.

RAPID Covid-19 Antigen Test


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