COVID-19 Testing FAQs
Under the EUA our COVID-19 Testing Kit is certified for use in high- and moderate-complexity laboratories.
To learn more, see the FDA’s guidelines.
If you require additional guidance, please contact your Local State or County Health Agency to ask for about using devices under emergency use authorization.
You can also review these links that might be helpful:
Please review the product insert regarding what type of blood sample will be appropriate to use in your test.
CLIA (The Clinical Laboratory Improvement Amendments) has established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results. Under CLIA, a lab is any facility that tests human specimens for a health assessment or to diagnose, prevent, or treat disease. Facilities that meet this definition must obtain CLIA certification to operate legally.
Yes, the test will detect both IgG and IgM. To find out more detailed product information and study results please fill out an interest form.
Please check the insert of the test you are using for the clinical data provided. If you would like, you can request the full clinical study from your account rep or using forms online
Please check the Letter to Health Care Providers on the FDA website regarding use of serological tests.
Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings can purchase our instant covid test . Our COVID-19 testing devices follow the highest quality standards. Interested in Instant Coronavirus Antigen Tests?
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.