This product is for in vitro diagnostic use only, following guidance from the FDA for tests submitted to the FDA for Emergency Use Authorization and Notification on March 16th, 2020, and amended on May 4th, 2020. While this test has been submitted for FDA EUA Authorization, it currently has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Please consult the manual for specific details and limitations of this test.
In response to the COVID-19 pandemic and to help increase screening, RayBiotech is offering this rapid serology test to laboratory and health professionals, and intended for use only in a high complexity laboratory or point of care when covered by a high complexity laboratory"s certificate. This kit is not intended for at home use. If you feel you need to be tested, please reach out to a local clinic or physician and ask them about offering this test. Wash, Screen, Save!
Antigen Information
- IGG
- IGM
Assay Format
- Human
- Blood
- Finger prick
- Serum
- Sandwich-based
- Qualitative
Product Specifications
If you are outside North America, please contact your nearest distributor and they will be able to assist you with pricing and availability.
Contact [email protected] for more information.
- Is this test for home use?
- What is the limit-of-detection (LOD) for this assay?
- What is the difference between the finger prick and serum/whole blood kits?
- What clinics currently have this test?
- I need a lot. Can you meet my demand?
- Are these tests covered by insurance?
- May I see your CE certification?
- Is this kit approved by the FDA?
- Do you have validation data to provide?
- How can I order these products?
- Do you have positive control samples for external validation?
Manual - IgM
Manual - IgG
Manual - IgM/IgG (dual cassette)
SDS - IgM
SDS - IgG
SDS - IgM/IgG (dual casette)
