LABScreen COVID Plus

Throughout the COVID-19 pandemic, we’ve heard from the transplant community that there’s an urgent need to understand the impact of this virus on transplant patients.

In response to this concern, One Lambda have developed a new serological assay for the detection of antibodies directed against COVID-19 (SARS-CoV-2) targeted toward transplant candidates and recipients. This novel antibody detection panel is a key part of our team’s mission to improve the lives of patients and their families during this global crisis.

Introducing the new LABScreen™ COVID Plus Assay

Research has found that pathogen infections like COVID-19 can increase HLA antibody levels in candidates awaiting transplantation.1 For transplant candidates with an undiagnosed COVID-19 infection, whether mild or asymptomatic, the virus may trigger a change in their HLA antibody profiles. Additionally, post-transplant patients may need to be monitored for the development of antibodies against both HLA and COVID-19 antibodies in order to make informed decisions on therapeutic interventions.

Our new LABScreen COVID Plus assay is designed for this purpose. It is a Luminex® xMAP®-based multiplex assay that can be run alongside the LABScreen Single Antigen or LABScreen Mixed assays to identify COVID-19 antibodies. With five distinct COVID-19 antigens and fragments, this assay is more specific than current assays with a single viral antigen. In addition, the multiplexed approach diminishes false positive results caused by seasonal coronavirus infections. Combined with HLA antibody detection, these reagents can provide a more complete picture of a patient’s antibody profile. 

Partnering for a More Comprehensive Antibody Test

When it became clear that HLA labs needed a more comprehensive COVID antibody test for transplant patients, Drs. Howard Gebel and Robert Bray, co-directors of the Emory University Hospital HLA laboratory, reached out to our team to collaborate on development. We invited Dr. Jar-How Lee, our company’s former CSO, to join our research team. Dr. Lee has been consulting with One Lambda on this complex assay since his retirement, and as always, we are grateful for his innovative thinking and scientific leadership.

Over the last few months, our team has been hard at work with histocompatibility, infectious disease and nephrology laboratories at Emory University, Stanford University, University of Cincinnati and the University Health Network (UHN) in Toronto to fast track this assay for Emergency Use Authorization (EUA) with the FDA. Pending our EUA submission, this assay is now available for research use only.

In my conversations with Dr. Gebel, he’s expressed excitement about the prospect of a Luminex-based assay to detect SARS-CoV-2 antibodies. “The current serological tests to detect SARS-CoV-2 antibodies were designed to look at a single viral target per assay. However, recent data has revealed that patient antibody responses to the SARS-CoV-2 virus are not uniform, and that only some antibodies are neutralizing and perhaps protective. We believed Dr. Lee’s expertise with antibody assay development was critical to rapidly bring a COVID-19 antibody test to market that meets the needs of transplant patients and programs,” said Dr. Gebel.

His colleague and fellow thought leader, Dr. Bray, said, “A semi-quantitative multiplex assay that can simultaneously detect the response to spike, receptor-binding domain, nucleocapsid and other SARS-CoV-2 proteins will be a huge step forward towards fully characterizing the immune response to COVID-19.” I look forward to seeing the exciting data and publications produced by his team and many others using the LABScreen COVID Plus assay.

Breaking Boundaries for Better Patient Care

As you know, transplant patients have unique needs compared to other COVID-19 patients. Not only are they immunosuppressed and at greater risk for infection, their candidacy for transplantation may be impacted or they may be at risk for a rejection event due to COVID-19. We’re excited to deliver an antibody panel that is tailored to the needs of these high-risk patients, and I would like to personally thank the teams at Emory, Stanford University, University of Cincinnati, and UHN for helping us meet this goal.

The past few months have proved a challenging time for all of us. But as I reflect on the great work done by our team and our colleagues across the field of transplantation, I’m reminded of the power of community: when we work together, we can break scientific boundaries, accelerate the development of new solutions, and make our world a safer, healthier place for transplant patients.

Now more than ever, we value your partnership and your feedback on our products and services. If you’d like to learn more about our new assay, please visit our website at onelambda.com/COVID-plus-antibodies.

REFERENCES

1. J. E. Locke, A. A. Zachary, D. S. Warren, D. L. Segev, J. A. Houp, R. A. Montgomery and M. S. Leffell. Proinflammatory Events Are Associated with Significant Increases in Breadth and Strength of HLA-Specific Antibody. American Journal of Transplantation 2009; 9: 2136–2139

Наименование	Объем	Производство	Метод	Кат.Номер
LABScreen COVID Plus		One Lambda	Мультиплексный анализ	LABScreen COVID Plus