Reverse Transcription Polymerase Chain Reaction tests (RT-PCR) are the recommended technology for the fast and accurate diagnosis of SARS-CoV-2, the virus that causes COVID-19 disease.
BIOFIRE® RESPIRATORY PANEL 2.1 is a rapid syndromic test that includes the detection of SARS-CoV-2. The BIOFIRE RP2.1 detects 21 additional respiratory pathogens to help clinicians quickly rule out other common causes of respiratory illness in about 45 minutes.
U.S. Food and Drug Administration (FDA) De Novo authorization
Extraction & RT-PCR Testing
NUCLISENS® Extraction Systems: EMAG® and easyMAG® equipment and associated reagents are essential for the extraction of nucleic acids prior to the amplification and detection of specific gene sequences used on several SARS-CoV-2 RT-PCR tests available on the market.
SARS-COV-2 R-GENE® is an open platform real-time Polymerase Chain Reaction (PCR) test for the qualitative detection of SARS-CoV-2 . It allows mid-to-high throughput molecular laboratories to receive results in 4 to 5 hours.
Authorized by FDA under an Emergency Use Authorization
VIDAS® SARS-COV-2 IgM and VIDAS® SARS-COV-2 IgG are automated qualitative assays for the detection of immunoglobulin M and immunoglobulin G, specific to the SARS-CoV-2 antigens in humans. These assays will work on all VIDAS® systems with no software updates required and will provide separate IgG and IgM results within 27 minutes.
Authorized by FDA under an Emergency Use Authorization
CLARION™ software-as-a-service (Saas) provides speed and agility that is essential to COVID-19 reporting. Our dynamic dashboards provide meaningful insights that help hospitals and clinicians monitor, analyze, and visualize their COVID-19 data. Click here to request more information on our 30-day, no obligation trial.
BIONUMERICS® SARS-CoV-2 Plug-In is a tool that facilitates the processing and analysis of SARS-CoV-2 genomic sequences whether generated by your own sequencing system or downloaded from a public database. Each genomic sequence imported into BIONUMERICS is analyzed for Single Nucleotide Polymorphisms (SNP) relative to the NCBI reference sequence for SARS-CoV-2 (NC_045512). Create dendrograms and minimum spanning trees to visualize viral strain relatedness.
Other Biomarkers Supporting COVID-19
Studies have found that a significant number of hospitalized COVID-19 patients are continuing to develop serious – and sometimes deadly – bacterial co-infections.1 Additional diagnostic biomarkers like VIDAS® B.R.A.H.M.S. PCT™ and rapid, comprehensive pneumonia diagnostics like the BIOFIRE® Pneumonia Panel can support well informed and timely clinical decisions throughout a patient’s stay in the hospital.2
Acute kidney injury (AKI) is an emerging complication associated with COVID-193 and a frequent complication among patients in the intensive care unit (ICU) who have or have had a respiratory compromise. bioMérieux is committed to providing continued support to facilitate the utilization of the NEPHROCHECK® Test [TIMP-2 • IGFBP-7] to aid in assessing the risk of moderate to severe AKI.4
Procalcitonin (PCT) testing on admission may provide additional information for early risk assessment, the rule out of a bacterial coinfection and guidance for initiation of antibiotic therapy.
Monitoring of PCT may be used to identify secondary infections and progression to a more severe disease state such as sepsis or septic shock. Elevated PCT levels in patients with a positive viral test, such as flu or COVID-19, provides evidence of a potential bacterial co-infection5. In addition, PCT can also provide additional guidance for initiation and discontinuation of antibiotic therapy.
D-dimer reflects the presence of stabilized fibrin, which has made this marker a useful tool in the diagnosis of venous thromboembolism (VTE).6 The VIDAS® D-DIMER EXCLUSION II™ test is indicated in conjunction with a pre-test probability model for the exclusion of VTE in outpatients (e.g., Emergency Department).
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- Not enough evidence currently exists that SAR-CoV-2 acts any differently than other viruses with respect to procalcitonin levels. VIDAS® B•R•A•H•M•S PCT™ is not cleared for the detection of SARS-CoV-2, and is not intended to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence.
- The VIDAS® D-DIMER EXCLUSION II™ test is not indicated to assess the risk nor the severity of SARS-CoV-2.
- The NEPHROCHECK® Test has not been specifically evaluated in patients with COVID-19 and the NEPHROCHECK Test is not FDA cleared to assess the risk nor severity of respiratory issues associated with COVID-19.
De Novo Status by U.S. FDA
- BIOFIRE® RESPIRATORY PANEL 2.1 test allows detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by U.S. FDA, having gone through the normal U.S. FDA review pathway outside of the Emergency Use Authorization (EUA) track.
- SARS-COV-2 R-GENE®, VIDAS® SARS-COV-2 IgG, and VIDAS® SARS-COV-2 IgM have not been FDA cleared or approved but been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- SARS-COV-2 R-GENE® has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
- VIDAS® SARS-COV-2 tests have been authorized only for detecting IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of SARS-COV-2 R-GENE®, VIDAS® SARS-COV-2 IgG, and VIDAS® SARS-COV-2 IgM 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
1. Michael J Cox, et al. Co-infections: potentially lethal and unexplored in COVID-19. The Lancet, April 24, 2020.
2. Verroken A, et al. Co-infections in COVID-19 critically ill and antibiotic management: a prospective cohort analysis. Critical Care. 2020;24(1). doi:10.1186/s13054-020-03135-7
3. Wendling P. Kidney complications in COVID-19 send hospitals scrambling. Medscape Medical News. April 20, 2020. https://www.medscape.com/viewarticle/929073. Accessed April 30, 2020.
5. Cuquemelle E, Soulis F, Villers D, et al. Can procalcitonin help identify associated bacterial infection in patients with severe influenza pneumonia? A multicentre study. Intensive Care Med. 2011;37(5):796-800.
6. Bockenstedt P. D-dimer in venous thromboembolism. N Engl J Med. 2003;349:1203-4.
PRN 056352 Rev05.A