If you are outside North America, please contact your nearest distributor and they will be able to assist you with pricing and availability.
This product is for in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. This test 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.
Contact [email protected] for more information.
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.
Since the patient may not know when they are infected, it is important to test for both IgM and IgG.
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.
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.
The test cartridges and diluent provided in the finger prick and serum/plasma kits are identical. The only difference is that the finger prick kit comes with materials necessary for capillary blood collection (lancets, alcohol swabs, bandages).
Buford-Norcross Primary Care
777 W Peachtree St.
Norcross, GA 30071
Yes, we can scale our production to meet your needs. Our typical turnaround time is 1 week.
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.
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.
Our IgG/IgM rapid test kit have a 95% sensitivity (true positive) and a 91% specificity (true negative) rate.
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.