AlloSure-Heart (Sendout)
General Information
Lab Name
AlloSure-Heart (Sendout)
Lab Code
RALLSR
Epic Name
AlloSure-Heart (Sendout)
Description
Test Description: AlloSure‐Heart® is a non‐invasive blood test that assesses organ health by directly measuring allograft injury. AlloSure‐Heart® helps to asses for acute rejection, potentially enabling better management of heart transplant recipients. The AlloSure‐Heart® test measures donor‐derived cell‐free DNA (dd‐cfDNA) in heart transplant recipients. Cell‐free DNA is present in plasma as a product of cell injury and death. dd‐cfDNA is fragments of DNA in the recipient’s bloodstream that originate from cells from the donated organ, and therefore are of the donor genotype and indicate specifically the level of graft cell injury and death.
Clinical validity of the AlloSure test was established by CareDx in heart transplant recipients who were 15 years of age or older and at least two months (55 days) post‐transplant (1).
Ordering Restrictions:
- Orderable only as part of the HeartCare Cardiac Tx Panel (Sendout) [RHRTCP].
- Laboratory Medicine Resident (LMR) approval is required for inpatient orders.
- This test is available to UW Medicine patients only.
References
- Khush, et al. Non‐invasive Detection of Graft Injury after Heart Transplantation Using Donor‐Derived Cell‐Free DNA: a Prospective Multi‐Center Study. Am J Transplant 2019.
- CareDx Test Information: HeartCare
Synonyms
AlloSure, AlloSure-Heart, CareDx HeartCare, dd-cfDNA, Donor-Derived cfDNA
Components
| Code | Name |
|---|---|
| RALSRR | AlloSure-Heart Result |
| RALSRL | AlloSure-Heart Performing Lab |
Interpretation
Reference Range
See individual components
Ordering & Collection
Specimen Type
Collection
Collection Restrictions: Due to the time-sensitive processing required, orders for HeartCare Cardiac Tx Panel (Sendout) [RHRTCP] must be pre-scheduled with UWMC Montlake Outpatient Blood Draw. This test cannot be drawn at other collection sites.
Collect 20 mL whole blood in 2 Streck Cell-Free DNA BCT® tubes (mottled black and tan).
- Fill tubes completely and mix by gently inverting 8-10 times.
- When labeling, do not cover up expiration date on the tubes.
- Lab staff may use Streck tubes on hand instead of those associated with a CareDx kit. However, a CareDx kit is required for the AlloMap (Sendout) [RALLMP] portion of the HeartCare test.
Approval Required
Laboratory Medicine Resident (LMR) approval is required for inpatient orders.
Handling Instructions
Outside Laboratories: This test requires special processing and is offered to UW Medicine patients only. Outside laboratories should arrange for testing directly with CareDx.
Quantity
requested: 20 mL whole blood in 2 full streck tubes
minimum: 8 mL whole blood in a single streck tube
Processing
Store and transport whole blood at room temperature.
Sendouts:
- Label the tubes and the requisition with the provided barcode labels (ensuring that the expiration date is visible). Leave the barcode labels blank (additional demographic information is not required as long as the tubes are labeled with LIS-generated labels).
- Affix the Sunquest Accession Label to the requisition (samples may be sent with the Epic requisition or with the CareDx HeartCare manifest).
- Accession labels are required to correlate the AlloSure and AlloMap orders that willl arrive at CareDx separately.
- Package samples and ship at room temperature using a CareDx kit. Samples must be properly packaged with the ambient gel pack or are subject to rejection.
- Samples may be shipped on Friday for Saturday delivery.
Stability: Ambient (Required): 7 days; Refrigerated: Not Acceptable; Frozen: Not Acceptable.
Performance
LIS Dept Code
Sendouts (SO)
Performing Location(s)
| Sendout |
CareDx
888-255-6627 3260 Bayshore Blvd. |
|---|
Frequency
Available STAT?
No