Frequently asked questions
Do you have validation data to provide?
The sensitivity of IgM and IgG tests combined against reference standard in overall study population is 90.44% (123/136, 95%CI: 84.21-94.81%). The specificity of IgM and IgG tests combined against reference standard in overall study population is 97.25% (459/472, 95%CI: 95.34-98.53%). The accuracy of IgM and IgG tests combined against reference standard in overall study population is 95.72% (582/608, 95%CI: 93.8-97.19%), with Kappa value of 0.8769.
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.
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.
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 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 antigenantibody interactions, and every person has different antibody affinities.
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.
Should I use the IgM or IgG window?
Since the patient may not know when they are infected, it is important to test for both IgM and IgG.
Is this a combined test for IgM and IgG?
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.