BakoDx Coronavirus (COVID-19) SARS-CoV-2 Test
BakoDx is receiving COVID-19 specimens and performing testing.
- You must contact your physician to order Coronavirus COVID-19 testing. BakoDx does not see patients. Click here for patient information.
BakoDx Laboratory Testing for COVID-19 Virus
COVID-19 Test Information
Getting Started with BakoDx COVID-19 Testing
- Complete and submit the form at the bottom of this page
- Email us: COVID19Test@bakodx.com
- Call us at: 1-855-422-5628
- General Information: www.fda.gov/novelcoronavirus
- Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
- Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html
- Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
- EUAs: (includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Request COVID-19 Virus Testing
If you are a healthcare provider or administrator of a healthcare facility and are interested in having testing provided by BakoDx, please provide your contact information below and someone will reach out to you soon.
COVID-19 Test Statements:
• This test has not been FDA cleared or approved.
• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• This test has been authorized only for the detection of 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.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up
testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform
• 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.