Frequently Asked Questions
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).
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.
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.
How can I order these products?
Four easy ways to order:
- You may also fill out the Order Form on our website
- You can call us at (404) 383-4099
- Send an email to firstname.lastname@example.org
- A sales rep will be happy to answer question and accept your orders via email or over the phone. Start the process by requesting more information via phone, email, or our online form. We will follow up with you promptly.
How can do I provide payment for my order?
We accept credit cards and wire transfers. Certain orders may require wire transfer. Contact your sales rep or call 404-383-4099 for additional details.
How can I re-order?
How can I learn more about serology testing?
The FDA and CDC are great resources to learn about serology testing. Their links are provided below.
How will my tests be shipped?
Please refer to our shipping page.