This test requires a certified technician to administer.
Please follow the link below to view and download the datasheet.
FDA Status: EUA Authorized: October 8, 2020
Test Type: Rapid Antigen; Nucleocapsid
Fast, accurate, point-of-care results.
CareStart rapid antigen test is CLLA Waiver and point-of—care authorized. With results in 10 minutes and a visual readout With no analyzer required, CareStartTM is the fastest way to diagnosis COVID-l9. More details, pricing, and availability soon.
88.4% Sensitivity, 100.0% Specificity
Specificity testing: No cross-reaction with other species
Interference testing: No interfering drugs or other factors identified except Biotin.
*See Instructions for Use for additional clinical data.
Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Who Can Perform Testing
This is a point-of-care authorized test. CLIA-certified laboratories with Waiver, Moderate, or High Complexity certification may perform the test at point-of-care or in laboratory setting.
Time to Result:
- Nasopharyngeal swab
- Internal control line appears when test is ready to be read.
What’s In the Packaging?
- 20 ASSAY BUFFER
- 20 EXTRACTION VIALS AND CAPS
- 20 SPECIMEN COLLECTION SWABS
- 1 POSITIVE AND 1 NEGATIVE CONTROL SWABS
- 1 INSTRUCTIONS FOR USE
Test Kit Waiver
By purchasing this test kit, I agree to forever hold harmless The Raw Office Inc., and all of its affiliates, assigns, contractors, suppliers and employees.
It is understood that these tests are for informational purposes only and are not used for diagnostic purposes. I understand and agree that anyone who takes a test is fully responsible for all decisions made after taking the test.
I hereby agree :
- I understand there are no guarantees about testing
- I understand that there can be false negatives
- I understand that follow-up measures (such as self-isolation), symptom management, and possibility of being contagious will not be based on this test alone. These will be based on symptoms, medical advice, local laws and/or possible exposures.