We have launched our assays across the globe including five COVID-19 tests with Emergency Use Authorizations (EUAs) since April 2020.

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.

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.*

• Capacity to run up to 130 tests per hour on our VITROS® 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 non-reactive (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

^{_{*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 role of high-throughput antigen testing during a pandemic

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.

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 recent or prior infection

VITROS^® Anti-SARS-CoV-2 IgG Quantitative Test

• 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*

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}}

Our proprietary, waterless VITROS^® Systems technology prepares your lab for maximum flexibility to respond to the needs of the pandemic. 

Learn about VITROS Integrated Systems ->

U.S. Food and Drug Administration (FDA): Available under Emergency Use Authorization (EUA)

SARS CoV-2 Antigen – Detects SARS-CoV-2 Nucleocapsid Antigens

Total (Anti-S) — Detects total antibodies including all isotypes (IgG, IgM, IgA) to the SARS-CoV-2 spike protein

Total (Anti-N) — Detects total antibodies including all isotypes (IgG, IgM, IgA) to the SARS-CoV-2 nucleocapsid protein

IgG (Anti-S) — Detects IgG antibodies to the SARS-CoV-2 spike 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

CE Mark

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

Antigen Testing Educational Resources 
https://www.orthoclinicaldiagnostics.com/en-us/home/covid-19#antigen-tests

Antibody Testing Educational Resources
https://www.orthoclinicaldiagnostics.com/en-us/home/covid-19#antigen-tests

Country-Specific Instructions for Use
https://techdocs.orthoclinicaldiagnostics.com/TechDocs/TechDocSearch.aspx?tID=0

Antibody Clinical Performance Data Publication List
https://www.orthoclinicaldiagnostics.com/assets/pdf/reference_cl_covidpublications_pr-12096.pdf

Recommended by Ortho: Diagnostic Tests for COVID-19 Patients
https://www.orthoclinicaldiagnostics.com/assets/pdf/reference_cl_covidpatientcare_pr-12097.pdf

The Role of High-Throughput Antigen SARS-CoV-2 Testing in a Large Metropolitan Hospital System
https://www.orthoclinicaldiagnostics.com/global/covid19/home/the-role-of-high-throughput-antigen-sars-cov-2-testing

Webinar: Clinical Utility of Ortho’s COVID-19 Antibody Tests
https://www.orthoclinicaldiagnostics.com/global/covid19/home/clinical-utility-of-orthos-covid-19-antibody-test

Answers to Your Coronavirus Neutralizing Antibodies Questions
https://www.orthoclinicaldiagnostics.com/global/covid19/home/answers-to-your-coronavirus-neutralizing-antibodies-questions

Neutralizing Antibodies to SARS-CoV-2: An Important Mechanism of Immunity
https://www.orthoclinicaldiagnostics.com/global/covid19/home/neutralizing-antibodies-to-SARS-CoV-2-an-important-mechanism-of-immunity

Podcast: Do Antibodies to COVID-19 Disappear?
https://www.orthoclinicaldiagnostics.com/en-us/home/do-antibodies-to-covid-19-disappear

Development of the CE-Marked VITROS® SARS-CoV-2 Antigen IA: A Viable Test for the Diagnosis of Symptomatic and Asymptomatic Individuals
https://www.orthoclinicaldiagnostics.com/assets/pdf/IFCC-2021-SARS-CoV-2-Antigen-Test-Poster_PR-10738.pdf

The Role of High-Throughput Antigen Tests in the COVID-19 Pandemic 
https://www.orthoclinicaldiagnostics.com/global/covid19/home/the-role-of-high-throughput-antigen-test-in-the-covid-19