AlloSure Lung
Use
AlloSure Lung is intended to assess the probability of lung allograft rejection in lung transplant recipients, particularly to inform clinical decision-making regarding the necessity of allograft biopsy in conjunction with standard-of-care clinical assessment. It measures the percent of donor‑derived cell‑free DNA (dd‑cfDNA) in peripheral blood as an indicator of graft injury; elevated dd‑cfDNA levels are associated with acute cellular rejection (ACR), antibody‑mediated rejection (ABMR) and chronic lung allograft dysfunction (CLAD). Interpretation should consider clinical context, and results are not intended for multi‑organ transplant recipients, pregnant recipients, or those with recent transfusions or biopsies within 24 hours prior to sample collection. Also, recent invasive procedures may transiently elevate dd‑cfDNA levels and affect interpretation.
Special Instructions
Not provided.
Limitations
Biological variability exists in baseline dd‑cfDNA values between and within individuals, and elevations may be due to recent biopsy or transfusions. It is not validated for multi‑organ transplant recipients, pregnant patients, or those who received blood transfusions within 30 days. Interpretation should always be made in clinical context combined with other diagnostic findings. The test has not been cleared or approved by the FDA.
Methodology
NGS (Targeted)
Biomarkers
dd‑cfDNA%
Other
Result Turnaround Time
3-5 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
Not provided
Minimum Volume
Not provided
