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Quantitative Test for Post-Transplant Pathogen Detection Improves Patient Outcomes

By LabMedica International staff writers
Posted on 12 May 2022
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Image: Aptima CMV Quant Assay for human cytomegalovirus has received FDA approval (Photo courtesy of Hologic)
Image: Aptima CMV Quant Assay for human cytomegalovirus has received FDA approval (Photo courtesy of Hologic)

Cytomegalovirus (CMV) is a common virus that typically causes mild or asymptomatic infections in people with healthy immune systems. However, transplant recipients typically are artificially immunosuppressed to prevent transplant rejection, which makes them more vulnerable to infections. If left untreated, CMV infection can lead to severe disease, transplant rejection and even death. CMV monitoring as standard of care can help guide treatment decisions for transplant patients, depending on their risk and transplant organ type. Now, a new assay to quantify the viral load of CMV in patients who have had solid organ or stem cell transplants can support patient care following transplant surgery.

Aptima CMV Quant assay is the first test to be introduced in the U.S. by Hologic, Inc. (Marlborough, MA, USA) for post-transplant pathogen detection and monitoring. The assay is an in vitro nucleic acid amplification test for the quantification of human CMV DNA in human EDTA plasma and whole blood on the fully automated Panther system. The Aptima CMV Quant assay involves three main steps, which take place in a single tube on the Panther system: target capture, target amplification by TMA, and detection of the amplification products (amplicon) by the fluorescently labeled probes (torches). It is intended for use to aid in the diagnosis and to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients. The Aptima CMV Quant assay has received US FDA approval and is also CE-marked for diagnostic and viral load monitoring use in Europe.

“We have a legacy of innovation in viral load testing, and our Aptima CMV Quant assay is the first in a series of planned quantitative assays to support patient care following transplant surgery,” said Michelle Garsha, President, Diagnostic Solutions at Hologic. “We’re committed to providing our laboratory partners with superior solutions that improve workflow efficiency, support provider and patient needs and address the challenges faced by today’s molecular lab.”

“It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients,” added Karen Harrington, PhD, Head of Scientific Affairs for Diagnostic Solutions at Hologic. “Our assay aligns with the international quantitative standards, offering laboratories and healthcare providers confidence in the results each and every time, ultimately helping to enhance patient management and outcomes.”

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