Oxford Immunotec’s T-SPOT.COVID Test is Used in the COV-AD Clinical Study to Investigate the Immunological Response to SARS-CoV-2 Infection in Patients with Primary and Secondary Antibody Deficiency
Oxford Immunotec, part of PerkinElmer, announced that its T-SPOT®.COVID test will be utilized in the COV-AD study, collaborating with the University of Birmingham. This study aims to monitor the SARS-CoV-2 infection and immune responses in patients with antibody deficiencies. Conducted across 13 UK sites, it seeks to determine the outcomes of COVID-19 in immunodeficient patients by assessing their T cell responses and antibody levels. The results could inform vaccination strategies and improve the understanding of immunity in vulnerable populations.
- Collaboration with University of Birmingham enhances clinical understanding of COVID-19 in immunodeficient patients.
- The T-SPOT.COVID test has CE marking for clinical use, indicating regulatory approval for its deployment.
- Potential to inform vaccination strategies and public health responses through findings from the COV-AD study.
- The PR does not disclose specific timelines for the study, which may delay insights into the pandemic's impact on immunodeficient individuals.
- No financial metrics provided, leaving uncertainty about the potential revenue impact from the trial.
OXFORD, United Kingdom and MARLBOROUGH, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- Oxford Immunotec a global, high-growth diagnostics company part of PerkinElmer, announced that its T-SPOT®.COVID test will be used for T cell testing in the COV-AD (COVID infection in patients with Antibody Deficiency) study in collaboration with the University of Birmingham. The study will monitor the clinical course of SARS-CoV-2 infection and the immunological response of patients to vaccination. The study will collect samples from 13 sites around the UK.
The COV-AD study aims to build on the UK Primary Immunodeficiency Network (UKPIN) data by determining the prevalence, course and outcomes of SARS-CoV-2 infection in patients with Primary Antibody Deficiency (PAD)/Secondary Antibody Deficiency (SAD). This study should lead to a clearer understanding of whether individuals with antibody deficiency mount durable immune responses, and if they do not, the impact that has on the virus itself. Development of anti-SARS-CoV-2 immunity to COVID infection or vaccination will be tested by blood sampling to measure specific antibody titre and for the presence of anti-SARS-CoV-2 T cells. The results of this study will be widely applicable to immunosuppressed patients, development of vaccination strategies and the understanding of risk for continuous virus transmission.
Oxford Immunotec’s T-SPOT.COVID kit is CE marked for IVD use and will be used to assess the T cell response in patients following SARS-CoV-2 infection or vaccination. The kit uses the T-SPOT technology platform, a commercialized, modified ELISPOT platform, which allows for the standardized and reproducible measurement of T cells reactive to SARS-CoV-2. The T-SPOT technology has previously been used in TB testing (the T-SPOT.TB test) where it is known to maintain its high performance even in immunosuppressed individuals. PAD/SAD are a diverse group of disorders, characterised by various degrees of dysfunctional antibody production. Understanding the T cell response to infection or vaccination in study subjects is therefore of critical importance to determining if the immune system is responding in these individuals at all. It could also help to increase the understanding of the role T cells play in combating COVID-19 in the general population.
Chief Investigator of COV-AD Professor Alex Richter, of the University of Birmingham, said: “Nationally, a number of patients with immunodeficiency have had severe or prolonged illness with COVID-19. Understanding why some patients do well and others do not, is so important. Being unable to clear the virus is not just a problem to the patient but is potentially a public health problem too.”
Dr. Andrew Makin, VP of Medical Affairs at Oxford Immunotec stated; “We are pleased to be partnering with the University of Birmingham on this clinical trial which will help characterize COVID-19 infection in patients with antibody deficiency. Measuring the T cell response in immune deficient patients will allow for a more comprehensive understanding of the immune response and inform on the vital role T cells may play in SARS-CoV-2 infection.”
For further information visit www.tspotcovid.com.
About Oxford Immunotec
Oxford Immunotec is a global, high-growth diagnostics company and part of the PerkinElmer group. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. The Company is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States (where it has received pre-market approval from the Food and Drug Administration), Europe (where it has obtained a CE mark), as well as Japan and China. The recently released T-SPOT.COVID test is CE marked in Europe for clinical use to understand the T cell immune response to SARS-CoV-2 infection and has been submitted to the FDA for emergency use authorization in the US (www.tspotcovid.com). The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately
About the University of Birmingham
The University of Birmingham is ranked amongst the world’s top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries. www.birmingham.ac.uk
For Media Inquiries:
US: Mary Conway
MKC Strategies, LLC
Tel: +1 (516) 606-6545
MConway@MKCStrategies.com
For Media Inquiries:
Megan Anderson
ZPB Associates
Mobile: 07597572287
Office: (020) 7018 1124
megan.anderson@zpb-associates.com
FAQ
What is the purpose of the COV-AD study involving PKI?
How will the T-SPOT.<em>COVID</em> test be used in the COV-AD study?
What are the implications of the COV-AD study results for immunodeficient patients?
When was the T-SPOT.<em>COVID</em> test CE marked for clinical use?
How many sites will participate in the COV-AD study?
