We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App




Heart Transplant Monitoring Test Validated

By LabMedica International staff writers
Posted on 06 Feb 2020
Print article
Image: The myTAIHEART test is a powerful non-invasive test that uses a small sample of blood to determine if a patient is at a low or increased risk of rejecting their heart transplant. myTAIHEART works by measuring the fraction of cell-free DNA (cfDNA) present in the bloodstream that is attributable to the transplanted heart. An elevated donor fraction (DF%) is associated with an increased risk of acute cellular rejection (Photo courtesy of TAI Diagnostics).
Image: The myTAIHEART test is a powerful non-invasive test that uses a small sample of blood to determine if a patient is at a low or increased risk of rejecting their heart transplant. myTAIHEART works by measuring the fraction of cell-free DNA (cfDNA) present in the bloodstream that is attributable to the transplanted heart. An elevated donor fraction (DF%) is associated with an increased risk of acute cellular rejection (Photo courtesy of TAI Diagnostics).
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease. Noninvasive risk assessment for rejection in heart transplant recipients, both adult and pediatric, is an imperative and urgent clinical need.

Organ-transplant patients require life-long immunosuppression that must be controlled carefully to balance risk of allograft rejection and loss with equally life-threatening immunosuppression-induced risks of infection, cancer, and other maladies. In heart transplant patients, this balance traditionally has been monitored through a multitude of diagnostic modalities.

A team of scientists led by those at the Medical College of Wisconsin (Milwaukee, WI, USA) clinically validated a rapid, highly sensitive, quantitative genotyping test using 158 matched endomyocardial biopsy-plasma pairs from 76 pediatric and adult heart transplant recipients. The test used is called the myTAIHEART (TAI Diagnostics, Wauwatosa, WI, USA) whose scientists cooperated in the study. From initial donor and recipient samples, the firm takes a baseline signature of 94 single nucleotide polymorphisms (SNPs) in genomic DNA (gDNA). It can then detect and quantify donor DNA in the transplant recipient's blood and calculate a donor fraction. These cell-free DNA (cfDNA) levels serve as a biomarker of viability, with rising donor fraction indicating a potential for transplant rejection.

To assure pre-analytical quality and consider interrelated cfDNA measures, plasma preparation was optimized and total cfDNA (TCF) concentration, DNA fragmentation, and donor-specific fraction (DF) quantification were validated in parallel for integration into myTAIHEART reporting. Analytical validations employed individual and reconstructed mixtures of human blood-derived gDNA, cfDNA, and gDNA sheared to apoptotic length. Precision, linearity, and limits of blank/detection/quantification were established for TCF concentration, DNA fragmentation ratio, and DF determinations.

For DF, multiplexed high-fidelity amplification followed by quantitative genotyping of 94 SNP targets was applied to 1,168 samples to evaluate donor options in staged simulations, demonstrating DF call equivalency with/without donor genotype. The clinical validation studies using 158 matched endomyocardial biopsy-plasma pairs from 76 pediatric and adult heart transplant recipients selected a DF cutoff (0.32%) producing 100% negative predictive value (NPV) for ≥2R acute cellular rejection (ACR).

Paula E. North, MD, PhD, a professor of pathology and lead author of the study, said, “The MyTAIHEART test can be used to stratify probability of moderate to severe ACR in heart transplant recipients. Another advantage is that the test is that it is a noninvasive test, which is particularly applicable in patients with limited vascular access, which is a relatively common problem in transplant patients. Furthermore, it can also be useful in stable patients after the first year post-transplant, and in patients who are too ill to undergo anesthesia and invasive biopsy. It is also a relatively inexpensive option compared to endomyocardial biopsy (EMB) that can potentially allow increased frequency of monitoring to detect rejection before it becomes clinically evident.” The study was published on January 13, 2020 in the journal PLOS ONE.

Related Links:
Medical College of Wisconsin
TAI Diagnostics


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
Real-time PCR System
GentierX3 Series

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.