When the world was faced with a pandemic, we didn’t waste any time in answering the call and delivering quality COVID-19 testing solutions in record time so labs could meet the needs of their patients and communities.
We were ready then and we remain dedicated today to meet the ever-changing needs with reliable, high-throughput testing solutions including antibody detection and antigen testing.
Because Every Test Is A Life™
See how we support clinicians and labs in the fight against COVID-19
Ortho Clinical Diagnostics, the first company to launch high-volume COVID-19 antibody and antigen tests with FDA Emergency Use Authorization
Ortho has been featured on the "Inspiring Minds" podcast hosted by the Edison Awards and focuses on todays most accomplished innovators and pioneers that are changing the world around us - modern-day Thomas Edison's. This podcast highlights the innovative approaches that our organization took early in the global pandemic to provide our diagnostic solutions when they were needed most. Click the link below to listen to the amazing story told by our Senior Director of Product Management, Nadav Kaufman.
We have launched our assays across the globe including five COVID-19 tests with EUAs since April 2020.
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 a SARS-CoV-2 diagnostic antigen test and antibody testing on the same high-throughput in-vitro diagnostics (IVD) system.
Antigen Tests
High-volume testing to help stop the spread of COVID-19, manage patient care and inform public health decisions.
VITROS® SARS‑CoV‑2 Antigen Test
High throughput Highly accurate Quick resultsThis rapid antigen test provides health care systems and communities more capacity to quickly and accurately diagnose individuals 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.
.png)
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 the SARS-CoV-2 virus. Critical response time, scalability and accuracy are key. High-throughput antigen testing has received attention for its ability to test high volumes quickly.
Molecular (PCR) tests
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 virus but can be costly and labor intensive.
Rapid POC antigen tests
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.
High-throughput antigen tests
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 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
Antibody Tests
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
Designed to capture IgG and total antibodies to the S1 spike protein. Qualitative assays with 100% specificity and good sensitivity.VITROS Anti-SARS-CoV-2 Total N Antibody Test
Designed to capture total antibodies to the nucleocapsid protein. Qualitative assay that detects immune response to SARS-CoV-2 infection.VITROS Anti-SARS-CoV-2 IgG Quantitative Test
Designed to detect and measure antibodies to the S1 spike protein. Quantitative assay with 100% specificity and good sensitivity. Calibrated to WHO standard.*Our COVID-19 antibody testing solutions can support laboratories’ needs today and into the future. This is the first standardized quantitative antibody test to receive U.S. Food and Drug Administration (FDA) 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 challenge
Current tests vary significantly, making it difficult to compare or aggregate data to understand antibody response.
The goal
Clinicians and researchers want to study immune response to SARS-CoV-2 and to compare results from different studies to understand immune protection in different patient populations.
The solution
A quantitative IgG antibody test calibrated to the WHO standard for SARS-CoV-2 immunoglobulin provides a way for accurate measurement and longitudinal monitoring of antibody titers over time.
Ortho’s Call to Action: The Role of Antibody Testing
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.
Read our call to action
How are antibody tests being used to fight COVID-19?
Review clinical performance data in these publications which reference our VITROS COVID-19 antibody tests.
Download publication list
COVID-19 Testing Solutions Available on One System
Our proprietary, waterless VITROS® Systems prepare your lab for maximum flexibility to respond to the needs of the pandemic. Learn about VITROS® Systems.
FDA: Available Under Emergency Use Authorization (EUA)
CE Mark
More Information
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.
