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 hp
Sign In
Advertise with Us
GLOBE SCIENTIFIC, LLC

Download Mobile App




Heart Transplant Monitoring Test Validated

By LabMedica International staff writers
Posted on 06 Feb 2020
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. More...
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



Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
PSA Assay
CanAg PSA EIA
New
Host Response Immunoassay Test
MeMed BV
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.