Ortho's VITROS® SARS-CoV-2 Antigen Test for High-Volume Testing Receives FDA Emergency Use Authorization for New Performance, Sensitivity Data
"Communities and laboratories across
New FDA-Emergency Use Authorized Only Claims Include:
- Improved Sensitivity Data
The VITROS® SARS-CoV-2 Antigen Test demonstrates 94.8% sensitivity for samples with a PCR cycle threshold (CT— an assessment of viral load), of less than 30.1 Studies 2,3 have shown that samples with PCR CT values at 30 - 33 or greater carry little to no live virus, suggesting these patients may no longer be infectious. This further solidifies the test's clinical utility in identifying individuals who are in the acute stage of COVID-19 infection when the risk for viral transmission is the highest.
- Updated Specimen Collection Methods
When utilizing Ortho's antigen test, personnel at hospitals, reference labs, and other healthcare settings will now be able to use a nasal sample which is more convenient than the nasopharyngeal swab specimen collection method. Further, the authorization allows for easier and faster sample collection.4
- Additional Viral Transport Media (VTM)
Testing leaders will now be able to utilize three additional viral transport media (VTM) options. Designed to preserve the integrity of collected samples during transportation to laboratories, new VTM options authorized for use with the VITROS® SARS-CoV-2 Antigen Test include Saline, which is readily available and cost effective, or Phosphate Buffered Saline (PBS), Bartels FlexTrans™ transport media [
Trinity Biotech], and the World Health Organization'sformulation of VTM, in addition to the CDC's formulation of VTM, COPAN Universal Transport Media (UTM)®, and Hardy R99 VTM—expanding options and testing capacity for customers who use Ortho's antigen assay.
About the VITROS® SARS-CoV-2 Antigen Test
Authorized for use in the
This project has been funded with federal funds from the
About Ortho's VITROS® COVID-19 Testing Solutions
Ortho's SARS-CoV-2 Antigen Test is the latest addition to the company's COVID-19 solutions, which include two COVID-19 antibody tests — Total and IgG — both of which have FDA EUA and CE Mark.
Because Ortho's VITROS Systems are already installed worldwide, reporting times may be further improved because lab staff require no additional training, and the instruments are already connected to existing laboratory information systems and software. These systems are self-contained and do not require an external water source to run.
Questions from laboratories, health care providers, or government officials regarding Ortho's COVID-19 solutions can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://www.orthoclinicaldiagnostics.com/global/covid19/.
The VITROS Anti-SARS-CoV-2 Total and IgG Antibody Tests and the VITROS SARS-CoV-2 Antigen Test have not been cleared or approved by the
More than 800,000 patients across the world are impacted by Ortho's tests each day. Because Every Test is a LifeTM, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.
From launching the first product to determine Rh+ or Rh- blood type, developing the world's first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first
The company is powered by
1 Using Nasopharyngeal Swab specimen collection. Nasal Swab specimen collection demonstrated 92.3% sensitivity at cycle thresholds values of less than 30.
2 Viral cultures for COVID-19 infectivity assessment. Systematic review.
3 N Engl J Med 2020;382:2081-90. DOI: 10.1056/NEJMoa2008457
4 Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
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Elaine Colón, Ortho Media Relations, M: +1 908 295 1579, email@example.com