Is this a combined test for IgM and IgG?
This is not a combined test – each cartridge detects either IgM or IgG only. In the interest of increased availability, we have prioritized production of the current test as opposed to R&D on a combined kit. We are developing a combined kit that will be available in the future.
Should I use the IgM or IgG kit?
Since the patient may not know when they are infected, it is important to test for both IgM and IgG.
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.
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 week.
Are these tests covered by insurance?
The billing code for non-CDC laboratory tests for SARS-CoV-2/COVID-19 is U0002. 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 95% sensitivity (true positive) and a
91% specificity (true negative) rate.
How can I order these products?
You can order here online.
How much is shipping?
For Rapid Tests there is a three (3) kit minimum order which costs $95 to ship.
Then there is a $5 shipping charge added per kit over and above the minimum order of three (3). IE: 4 kits would be $95 + $5 = $100 for shipping.