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Description
FAQs
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Note:

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

Gene Symbols:

Assay Format

Number of Targets Detected:

Species Detected:

Human

Compatible Sample Types:

Blood
Finger prick
Serum

Design Principle:

Sandwich-based

Method of Detection:

Colloidal Gold

Quantitative/Semi-Quantitative:

Qualitative

Solid Support:

Lateral Flow

Product Specifications

Size:

20 Tests

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?

This is not an over-the-counter product for home use. The test must be administered by a licensed medical professional. However, it is a POC (point of care) test that does not require sending samples to a lab. Therefore, the results can be obtained on-site at a clinic.
What is the limit-of-detection (LOD) for this assay?

There is no known LOD of this assay. The kit is qualitative and is based on antigen-antibody interactions, and every person has different antibody affinities.
What is the difference between the finger prick and serum/whole blood kits?

The test cartridges and diluent provided in the finger prick and serum/whole blood kits are identical. The only difference is that the finger prick kit comes with materials necessary for capillary blood collection (lancets, alcohol swabs, bandages).
What clinics currently have this test?

Buford-Norcross Primary Care
777 W Peachtree St.
Norcross, GA 30071
dekalbmedical.org

Global 7 Diagnostics
3240 Pointe Pkwy, Suite 200
Norcross, GA 30092
global7dx.com
[email protected]
I need a lot. Can you meet my demand?

Yes, we can scale our production to meet your needs. Our typical turnaround time is 1-2 days.
Are these tests covered by insurance?

The billing code for non-CDC laboratory tests for SARS-CoV-2/COVID-19 is 86328. The patient's insurance company should be contacted to determine coverage and pricing.
May I see your CE certification?

View CE Certificates
Is this kit approved by the FDA?

These kits are for in vitro diagnostic use and have been submitted for Emergency Use Authorization following guidance from the FDA on March 16, 2020. The tests have 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 (COVID-19) infection or to inform infection status.
Do you have validation data to provide?

Our IgG/IgM rapid test kit have a 90.4% sensitivity (true positive) and a 98.3% specificity (true negative) rate.
How can I order these products?

You can order here online or call (888) 494-8555. If you are outside North America, please contact your nearest distributor and they will be able to assist you with pricing and availability.
Do you have positive control samples for external validation?

Yes, we offer inactivated serum and EDTA-treated plasma samples from patients confirmed to have COVID-19 via RT-PCR and our coronavirus IgM or IgG rapid tests. You can order the serum or plasma samples here:

COVID-19 Serum or Plasma Samples
COVID-19 Serum or Plasma Sample Set