The BioCode® SARS-CoV-2 Assay is a molecular assay based on reverse transcription polymerase chain reaction (RT-PCR) and end-point detection of amplified DNA sequences with analyte-specific probes that are coupled to barcoded magnetic beads (BMB) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), and nasal swabs) or bronchoalveolar lavage (BAL) from individuals suspected of COVID-19 by their healthcare provider (HCP).
For use on the BioCode® MDx-3000 system, this molecular diagnostic assay is authorized for emergency use by the FDA*.
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 Assay detects two conserved regions of the SARS-CoV-2 N gene. It does not detect these common coronaviruses:
The BioCode® SARS-CoV-2 Assay is validated for use with the following upper respiratory specimens:
The BioCode® SARS-CoV-2 Assay supports pooled testing of up to five individual upper respiratory specimens (NPS, OPS, and nasal swabs), reducing per-test costs and increasing laboratory throughput.
While the BioCode® SARS-CoV-2 assay is not cleared or approved by the FDA, it is authorized for emergency use under an Emergency Use Authorization (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 the BioCode® SARS-CoV-2 Assay, contact Applied BioCode Inc. today.
