Prospera™ Heart Transplantation Assessment
Use
Prospera™ Heart Transplantation Assessment is a noninvasive blood test designed for monitoring rejection in heart transplant recipients by measuring donor-derived cell‑free DNA (dd‑cfDNA). Utilizing Natera’s proprietary massively multiplexed PCR (mmPCR) technology without the need for donor or recipient genotyping, the assay delivers two key metrics—dd‑cfDNA fraction (dd‑cfDNA %) and Donor Quantity Score (DQS)—to enhance detection accuracy of both acute cellular rejection (ACR) and antibody‑mediated rejection (AMR), potentially reducing reliance on invasive endomyocardial biopsies and improving clinical risk assessment. This approach has demonstrated strong diagnostic performance across multiple clinical studies, supporting its use in personalized surveillance and early detection of graft injury.
Special Instructions
Not provided.
Limitations
Not FDA‑cleared or approved; developed and validated in CLIA‑certified, CAP‑accredited, and ISO 13485‑certified labs. For pediatric use, optimized for ages 7 and older. Clinical performance is based on studies with specific cohorts; while performance (AUC, sensitivity, specificity) has been strong, results may vary and should be interpreted in context. Missing requisition or patient information may delay turnaround time.
Methodology
PCR-based (PCR)
Biomarkers
dd‑cfDNA fraction (dd‑cfDNA %)
SignatureDonor Quantity Score (DQS)
Signature
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Single blood draw; no spin‑down required at collection site.
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