Frequently Asked Questions

Yes, they are combined together into a single cassette. There is a separate window to place the blood sample for IgG and IgM that are clearly marked.

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 antigenantibody interactions, and every person has different antibody affinities.

Yes, we can scale our production to meet your needs. Our typical turnaround time is 10 – 14 days per shipping policy.

The billing codes for non-CDC laboratory test for SARS-CoV-2/COVID-19 is 86328 and 86769.  The patient’s insurance company should be contacted to determine coverage and pricing.  Click here for a comprehensive list of insurance companies and an explanation of their COVID-19 testing policies. For Medicare Part B coverage information click here. Here are the CPT Codes and the Antibody Test Codes.

These kits are for in vitro diagnostic use and have been authorized for use by FDA EUA. The tests 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 98.23% Accurate/ Sensitivity 98.88% / Specificity 97.50%. Learn more

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