01
Innovation
See our milestones along the way.
VITROS® COVID-19 Testing Solutions
For more than 80 years, we have delivered reliable testing solutions that you and your community can count on. We are proud to be among the first to offer SARS-CoV-2 diagnostic antigen and antibody tests on the same high-throughput in vitro diagnostics (IVD) system.
02
Antigen Tests
VITROS® SARS-CoV-2 Antigen Test
✔ High throughput
✔ Highly accurate
✔ Quick results
This lab-based antigen test provides health care systems and communities more capacity to diagnose individuals quickly and accurately with an active SARS-CoV-2 infection. The test is a laboratory immunoassay for the in-vitro qualitative detection of the SARS-CoV-2 nucleocapsid antigen.*
*Available only in the U.S. market under Emergency Use Authorization with the U.S. Food and Drug Administration. Availability of assays varies by country.
**Refer to country-specific VITROS® Immunodiagnostic Products SARS-CoV-2 Antigen Instructions for Use for sensitivity and specificity performance data and intended use.
†For symptomatic individuals, specimens are to be collected using nasopharyngeal and nasal swabs.
‡Asymptomatic use is subject to regulatory approval outside the U.S.
The COVID-19 pandemic has challenged the health care community to consider testing strategies that will support critical public health initiatives to detect the spread of SARS-CoV-2. Critical response time, scalability and accuracy are key. High-throughput antigen testing has received attention for its ability to test high volumes quickly.
The COVID-19 pandemic has challenged the health care community to consider testing strategies that will support critical public health initiatives to detect the spread of SARS-CoV-2. Critical response time, scalability and accuracy are key. High-throughput antigen testing has received attention for its ability to test high volumes quickly.
Polymerase chain reaction (PCR) tests amplify the target DNA or RNA sequence to generate a quantifiable signal. These tests are highly accurate at detecting small amounts of the virus but can be costly and labor-intensive.
These antigen tests target viral proteins and can be done in the laboratory or administered as a rapid test with a point-of-care (POC) device. Rapid tests produce results faster; however, throughput is limited on a single POC device.
These tests target viral proteins similar to the POC tests and provide a testing option that can help labs run a high volume of tests that can return accurate results in a quicker timeframe than PCR tests.
“Our switch to high-throughput antigen testing met our goal to improve the reliability of results and to stabilize turnaround time. Our laboratory and clinicians appreciate having this testing strategy in the armamentarium of diagnostic and clinically supportive tests to better serve our patients.”
—Karen Roush, MD, MBA, Methodist Health System, Dallas, TX
03
These tests provide highly accurate and reliable detection of SARS-CoV-2 antibodies to help clinicians and researchers understand immune response.
VITROS® COVID-19 Total and IgG Antibody Assays
Our COVID-19 antibody testing solutions can support laboratories’ needs today and in the future. This is the first standardized quantitative antibody test to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). It helps labs quantify the level of COVID-19 antibodies for patients and individuals in their communities and monitor its persistence over time.
*WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human) NIBSC 20136
The COVID-19 pandemic has challenged the health care community to consider testing strategies that will support critical public health initiatives to detect the spread of SARS-CoV-2. Critical response time, scalability and accuracy are key. High-throughput antigen testing has received attention for its ability to test high volumes quickly.
Polymerase chain reaction (PCR) tests amplify the target DNA or RNA sequence to generate a quantifiable signal. These tests are highly accurate at detecting small amounts of the virus but can be costly and labor-intensive.
These antigen tests target viral proteins and can be done in the laboratory or administered as a rapid test with a point-of-care (POC) device. Rapid tests produce results faster; however, throughput is limited on a single POC device.
These tests target viral proteins similar to the POC tests and provide a testing option that can help labs run a high volume of tests that can return accurate results in a quicker timeframe than PCR tests.
“Our switch to high-throughput antigen testing met our goal to improve the reliability of results and to stabilize turnaround time. Our laboratory and clinicians appreciate having this testing strategy in the armamentarium of diagnostic and clinically supportive tests to better serve our patients.”
—Karen Roush, MD, MBA, Methodist Health System, Dallas, TX
The world needs serology testing to help understand and fight SARS-CoV-2
We believe serological testing is key to identifying surrogate markers for immune protection and better understanding immunity.
Review clinical performance data in these publications which reference our VITROS COVID-19 Antibody Tests.
This website contains information that is targeted to a wide range of audiences and could contain product details or information otherwise not valid or applicable to your country. Consult your local legal restrictions, regulations, registrations or intended uses in your country of origin. Product availability may vary from country to country and is subject to varying regulatory requirements.
The VITROS Anti-SARS-CoV-2 IgG Quantitative, VITROS Anti-SARS-CoV-2 Total N Antibody, VITROS SARS-CoV-2 Antigen, VITROS Anti-SARS-CoV-2 Total and VITROS Anti-SARS-CoV-2 IgG Antibody Tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). They have been authorized by the FDA under an Emergency Use Authorization (EUA) and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate- or high-complexity tests.
The VITROS Antibody Tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. The VITROS Antigen Test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. These tests are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
