Our proprietary, waterless Vitros Systems technology prepares your lab for maximum flexibility to respond to the needs of a pandemic.
We support clinicians and labs in the fight against COVID-19
We launched our assays across the globe including five Vitros® COVID-19 tests with Emergency Use Authorizations (EUAs) since April 2020. And now QuidelOrtho has been granted FDA De Novo classification for Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Assay and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Assay.
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 test on the same high-throughput in vitro diagnostics (IVD) system. High-volume testing helps stop the spread of COVID-19 so you can manage patient care and inform public health decisions.
Serological testing is key to identifying surrogate markers for immune protection.
Vitros COVID-19 testing solutions are a viable alternative to PCR testing. Results report either positive or negative with no gray zone.*
Quickly diagnose with the Vitros SARS-CoV-2 Antigen Test†
High-volume testing to help stop the spread of COVID-19, manage patient care and inform public health decisions.
This lab-based Vitros SARS-CoV-2 Antigen Test provides healthcare systems and communities more capacity to diagnose individuals with active SARS-CoV-2 infections.*
High throughput
Highly accurate
Quick results
The test is a laboratory immunoassay for the in vitro qualitative detection of the SARS-CoV-2 nucleocapsid antigen.†
Capacity to run up to 130 tests per hour on our Vitos® XT 7600 and 5600 Integrated Systems and Vitros® 3600 Immunodiagnostic System
Excellent specificity and sensitivity, making it a viable alternative to PCR testing*
Results are reported as either reactive (positive) or nonreactive (negative) with no gray zone
Simple sample preparation for swabs placed in a viral transport medium‡§
Can be run alongside other IVD tests needed for routine testing or patient management
The role of high-throughput antigen testing during a pandemic
Critical response time, scalability and accuracy are key to responding to public health concerns during a pandemic. High-throughput antigen testing has received attention for its ability to test high volumes quickly.
The COVID-19 pandemic challenged the healthcare community to consider testing strategies that support critical public health initiatives to detect the spread of SARS-CoV-2
- Molecular (PCR) tests
- Rapid POC antigen tests
- High-throughput antigen 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 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, but throughput is limited on a single POC device.
These tests target viral proteins similar to POC tests and provide a testing option that can help labs run a high volume of tests that can return accurate results in a shorter 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
Our COVID-19 antibody testing solutions can support laboratories’ needs today and in the future.
- Designed to capture IgG and total antibodies to the S1 spike protein
- Qualitative assays with 100% specificity and good sensitivity
- First high-throughput, automated SARS-CoV-2 antibody tests to be granted market authorization from the U.S. FDA through De Novo classification
- These tests have become the predicate device upon which subsequent devices of the same type and intended use will be cleared
- Designed to capture total antibodies to the nucleocapsid protein
- Qualitative assay that detects immune response to recent or prior infection
- Under Emergency Use Authorization by the FDA
- Designed to detect antibodies to the S1 spike protein
- Quantitative assay with 100% specificity and good sensitivity
- Calibrated to the World Health Organization’s (WHO) standard||
This is the first standardized quantitative antibody test to receive U.S. (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.
Regulatory status by Vitros COVID-19 testing type
Total (Anti-S) – Detects total antibodies to the SARS-CoV-2 spike protein.
IgG (Anti-S) – Detects IgG antibodies to the SARS-CoV-2 spike protein.
SARS CoV-2 Antigen – Detects SARS-CoV-2 Nucleocapsid Antigens
Total (Anti-N) – Detects total antibodies including all isotypes (IgG, IgM, IgA) to the SARS-CoV-2 nucleocapsid protein
Quantitative IgG (Anti-S) – Measures an individual’s IgG antibody response over time post-infection to SARS-CoV-2 and provides numerical values correlated to the World Health Organization’s (WHO) standard for Anti-SARS-CoV-2 immunoglobulin
Total (Anti-S) – Detects total antibodies including all isotypes (IgG, IgM, IgA) to the SARS-CoV-2 spike protein and provides a semi-quantitative value
Semi-quantitative IgG (Anti-S) – Detects IgG antibodies including all isotypes (IgG, IgM, IgA) to the SARS-CoV-2 spike protein and provides a semi-quantitative value
Quantitative IgG (Anti-S) – Measures an individual’s IgG antibody response to SARS-CoV-2 spike protein and provides numerical values correlated to the WHO standard for Anti-SARS-CoV-2 immunoglobulin
May not be available in all regions.
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Related products
*Refer to country-specific Vitros® Immunodiagnostic Products SARS-CoV-2 Antigen Instructions for Use for sensitivity and specificity performance data and intended use.
†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.
‡For symptomatic individuals, specimens are to be collected using nasopharyngeal and nasal swabs.
§Asymptomatic use is subject to regulatory approval outside the U.S.
||WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human) NIBSC 20136
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 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. FDA has granted De Novo classification for Vitros Anti-SARS-CoV-2 Total and Vitros Anti-SARS-CoV-2 IgG Antibody Tests.
