BioMérieux SARS-CoV-2 Serology Tests Granted FDA Emergency Use Authorization
By LabMedica International staff writers Posted on 11 Aug 2020 |
Illustration
BioMérieux’s (Marcy-l'Étoile, France) has been granted Emergency Use Authorizations (EUAs) by the US Food and Drug Administration (FDA) for two SARS-CoV-2 serology tests.
The FDA has granted EUA to BioMérieux’s VIDAS SARS-COV-2 IgM and VIDAS SARS-COV-2 IgG automated qualitative assays which rapidly detect antibodies to help identify individuals with previous exposure to SARS-CoV-2. With the same protocols to differentiate IgM and IgG results, the VIDAS SARS-COV-2 IgM detects IgM specific for SARS-CoV-2 while the VIDAS SARS-COV-2 IgG detects IgG specific for SARS-CoV-2.
Both the assays use a two-step sandwich enzyme immunoassay method with final fluorescence detection (ELFA). Available on-demand 24/7 on all VIDAS platforms, they offer flexibility and reliability for results in less than 30 minutes. All the assay steps are performed automatically by the instrument which is intuitive and easy to use with limited maintenance, calibration and controls. Both the assays deliver a performance with high specificity and sensitivity from day eight and generate results that help provide additional pandemic analysis data. According to the FDA, both the tests can be used by any lab CLIA-certified to perform moderate- or high-complexity testing.
Related Links:
BioMérieux
The FDA has granted EUA to BioMérieux’s VIDAS SARS-COV-2 IgM and VIDAS SARS-COV-2 IgG automated qualitative assays which rapidly detect antibodies to help identify individuals with previous exposure to SARS-CoV-2. With the same protocols to differentiate IgM and IgG results, the VIDAS SARS-COV-2 IgM detects IgM specific for SARS-CoV-2 while the VIDAS SARS-COV-2 IgG detects IgG specific for SARS-CoV-2.
Both the assays use a two-step sandwich enzyme immunoassay method with final fluorescence detection (ELFA). Available on-demand 24/7 on all VIDAS platforms, they offer flexibility and reliability for results in less than 30 minutes. All the assay steps are performed automatically by the instrument which is intuitive and easy to use with limited maintenance, calibration and controls. Both the assays deliver a performance with high specificity and sensitivity from day eight and generate results that help provide additional pandemic analysis data. According to the FDA, both the tests can be used by any lab CLIA-certified to perform moderate- or high-complexity testing.
Related Links:
BioMérieux
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants