AlloSure Kidney
Use
AlloSure Kidney is a non‑invasive, transplant‑specific donor‑derived cell‑free DNA (dd‑cfDNA) blood test designed for earlier detection of kidney allograft injury and rejection. It analyzes SNPs across all 22 somatic chromosomes to quantify dd‑cfDNA levels, which serve as a leading indicator of graft injury. Elevated AlloSure levels are highly associated with all types and severities of kidney rejection, independently of standard clinical parameters, and provide improved detection and risk stratification over traditional markers such as serum creatinine, DSA, eGFR, proteinuria, and biopsy. It enables clinicians to detect molecular rejection prior to histological injury and clinical signs, improving early intervention and graft surveillance outcomes. This assay has been validated in large real‑world and prospective studies, including ADMIRAL and KOAR, and may elevate months earlier than detectable by DSA or biopsy. Lower dd‑cfDNA levels offer high negative predictive value. Clinical utility is further enhanced by integration within longitudinal monitoring and AI‑derived insights via AlloSure Plus.
Special Instructions
Not provided.
Limitations
AlloSure Kidney is intended for renal transplant recipients aged 18 years or older who are at least 2 weeks (14 days) post‑transplant; it should not be used for other transplanted organs. Assay performance may be limited by timing of draw and collection window; sample collection is limited to specific days. The test result is intended to assist clinical decision‑making and not used in isolation—clinical context and other diagnostic information must guide management. AlloSure Plus output is not diagnostic and should not be used as the sole basis for treatment decisions.
Methodology
NGS (Targeted)
Biomarkers
dd‑cfDNA fraction (%)
Other
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Blood is collected from the patient, packaged, and shipped at ambient temperature; collection should be performed Monday–Thursday
