Ortho Clinical Diagnostics Presents Six Posters at 2021 Virtual AABB Annual Meeting

Raritan, NJ

Ortho Clinical Diagnostics Holdings plc (NASDAQ: OCDX), one of the world's largest pure-play in vitro diagnostics companies, presented six posters highlighting the company's COVID-19 and Transfusion Medicine innovations at the 2021 Virtual Association for the Advancement of Blood & Biotherapies (AABB) Annual Meeting, a yearly event that showcases cutting-edge research, technology and service advances in the blood banking industry.

“The posters presented at the 2021 Virtual AABB Annual Meeting showcase our immediate response to the COVID-19 pandemic along with advancements in technology and our focus on delivering education to the health care community to drive meaningful innovation that continues to transform the in-vitro diagnostics space,” said Andrew Corkum, head of Ortho's transfusion medicine product portfolio. “We remain dedicated to solving our customers’ challenges with customized solutions that deliver exceptional patient care today and meet the demands of the future.”

Ortho’s poster presentations included:

Ability to Monitor from Afar, Key to Instrument Reliability in the Pandemic Period

Unexpected downtime can have a dramatic impact on the operational performance of the laboratory. Creative solutions that anticipate and minimize that impact are integral to instrument selection. During the COVID-19 pandemic this was more evident than ever before. This study measured the impact of ORTHO VISION® remote monitoring through e-Connectivity® by the manufacturer, along with the Smart Service app for the field service technician. The study found that the Smart Service app along with preexisting monitoring capability enhanced substantially instrument availability to perform testing.

An Evaluation of Performance of the VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Assay*

This study was designed to assess the clinical and analytical performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack (VITROS IgG Quant) on the VITROS family of analyzers and found that VITROS IgG Quantitative assay demonstrates excellent clinical and analytical performance and can detect quantitative antibody response to COVID-19 infection or vaccination. This assay is a first step toward understanding the rise and fall of antibodies in individuals and the long-term impacts of the COVID-19 pandemic on communities and the overall population.

The assay is the first to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the quantitative detection of SARS-CoV-2 IgG antibodies with calibration traceable to the first WHO International Standard for Anti-SARS-CoV-2.

_{*Dilution and vaccine performance not authorized by FDA.}

Performance of the VITROS^® Immunodiagnostic Products SARS-CoV-2 Antigen Assay

This study was designed to assess the clinical and analytical performance of the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen assay (VITROS SARS-CoV-2 Antigen) on the VITROS 3600 Immunodiagnostic System and the VITROS 5600/ XT 7600 Integrated Systems and found that the VITROS SARS-CoV-2 Antigen assay demonstrates excellent clinical agreement with RT-PCR and can be used as an aid in identifying individuals with active SARS-CoV-2 infection. Ortho's VITROS® SARS-CoV-2 Antigen Test was the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and is critical to helping communities get accurate, reliable results they can count on during the pandemic.

Changing Dynamics in Education in the COVID Pandemic Era

This study measured the engagement from healthcare and laboratory professionals with Ortho's COVID-19 educational podcast episodes and webinars to help bridge knowledge gaps and drive exceptional patient care. The study found that the COVID-19 pandemic had a dramatic impact on health care professionals worldwide, with education being one with typical avenues of delivery hindered. Overall, the digital approach to educational offerings has enhanced continuing education during a challenging time.

Assuring ABO Compatibility Detection Using Full Automation

As automation for immunohematology tests has expanded, the interest in maintaining a serological test on an automated system for the immediate spin cross match (ISXM) test has persisted. This study was undertaken to demonstrate that the ORTHO VISION^® Analyzer platform would detect ABO incompatibility based on the expected result of crossmatch pairing. This study found that eliminating the manual performance of the ISXM test, by fully automating the test on the instrument, used to process all other routine immunohematology tests, is an important contributor to the safety and security that automation brings to the transfusion service.

A Semiautomated Reader Solution Designed to Deliver Equivalence in Results

Automation of immunohematology testing has developed a stronger foothold in many transfusion services as instrument capability and software resourcefulness have expanded the safety and security of testing. This study examines how laboratories relying on manual processes would benefit from a semiautomated solution that delivers results consistent with a full automation solution to help reduce risks. Using elements of a full automation instrument imaging system and software, a new reader system, ORTHO OPTIX™ Reader (OPTIX) was developed. This study validated the performance of the reader compared to the ORTHO VISION® Analyzer (VISION) for concordance.

To view and learn more about the abstracts authored by Ortho at the 2021 Virtual AABB Annual Meeting, visit www.orthoclinicaldiagnostics.com/en-us/home/scientific-posters. Find more about Ortho's history of innovation at OrthoClinicalDiagnostics.com/OurStory.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies.

More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life™, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.

From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years.

The company is powered by Ortho Care™, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.

For more information, visit Ortho’s social media channels: LinkedIn, Twitter, Facebook and YouTube.