COVID-19 Testing Solutions

Innovation and agility define our commitment to COVID-19 testing

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 LifeTM

COVID-19 Testing Solutions

Innovation and agility define our commitment to COVID-19 testing

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 LifeTM

01

Innovation

See how we support clinicians and labs in the fight against COVID-19

 

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.

02

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 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.

The role of high-throughput antigen testing during a pandemic

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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.

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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 the virus but can be costly and labor-intensive.

 

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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.

 

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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.

 

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“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

Antibody Tests

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 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

Why standardized quantitative antibody tests are a useful tool in measuring immune response to COVID-19

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The Challenge

Current tests vary significantly, making it difficult to compare or aggregate data to understand antibody response.

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The Goal

Clinicians and researchers want to be able to understand immune response or protection so they can make appropriate recommendations for individual patients and their community.

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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.

How antibody tests are being used to fight COVID-19

Review clinical performance data in these publications which reference our VITROS COVID-19 Antibody Tests.

04

Analyzers

COVID-19 Testing Solutions available on one system

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 ->

05

Regulatory Status

Regulatory status by COVID-19 testing type

 

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

06

Resources

COVID-19 Testing Resources

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

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.

Accurate test results.
When you need them.

Because Every Test Is A LifeTM

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