For use on the MDx-3000 system, the BioCode® SARS-CoV-2 Assay* is designed to detect two different conserved regions of SARS-CoV-2 N gene. The Assay does not detect common coronaviruses (OC43, HKU1, NL63, and 229E, MERS-CoV, or SARS-CoV).
The test is intended for the qualitative detection of SARS-CoV-2 in upper respiratory specimens such as nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), and nasal swabs or bronchoalveolar lavage (BAL) from individuals who are suspected of COVID-19 by their healthcare provider.
Reach out to Applied BioCode to get more information about ordering this product.
Part No. 64-C0304
*The BioCode® SARS-CoV-2 Assay has not been FDA cleared or approved; the test has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests. The BioCode® SARS-CoV-2 Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Emergency use of the BioCode® SARS-CoV-2 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The following are commonly asked questions about the BioCode SARS-CoV-2 Assay. If your question is not addressed below, contact Applied BioCode Inc. to learn more.
The BioCode® SARS-CoV-2 diagnostic testing assay can detect two conserved regions of the SARS-CoV-2 N gene. It does not detect these common coronaviruses:
This assay tests these upper respiratory specimens:
Laboratories can use pool testing for the BioCode® SARS-CoV-2 diagnostic testing assay to save on testing expenses. The assay supports pooled testing of up to five individual upper respiratory specimens (NPS, OPS, and nasal swabs).
While the BioCode® SARS-CoV-2 assay is not cleared or approved by the FDA, it is authorized for emergency use (EUA). This test can be run in parallel with FDA-cleared BioCode® assays.
The BioCode® Molecular Diagnostic Tests for SARS-CoV-2 are authorized for use by laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a. This certification means the laboratory meets the requirements to perform high-complexity tests.
Laboratories can use these extraction systems with the BioCode® SARS-CoV-2 assay:
To order or learn more about BioCode® Molecular Diagnostic Tests for SARS-CoV-2, contact Applied BioCode Inc. today.
