Allosure Kidney Tx Recipient dd cfDNA (Sendout)

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General Information

Lab Name
Allosure Kidney Tx Recipient dd cfDNA
Lab Code
RKDDCD
Epic Name
Allosure Kidney Tx Recipient dd cfDNA (Sendout)
Description

Test Description: The AlloSure test measures donor-derived cell-free DNA (dd-cfDNA) in renal transplant recipients. dd-cfDNA refers to fragments of DNA in the recipient’s bloodstream that originate from cells undergoing cell injury and death. AlloSure is indicated for use in renal transplant patients who are 18 years of age or older and at least 2 weeks (14 days) post-transplant.

Ordering Requirements: Include the following information in the EPIC order: date of transplant, donor status (living/unrelated, living living/related, or deceased), and relationship of donor to recipient (if related).

Ordering Restrictions:

  • Laboratory Medicine Resident (LMR) approval is required for inpatient orders.
  • This test is available to UW Medicine patients only.
References
  1. Grskovic et al., J Mol Diagn 2016
  2. Bloom et al., J Am Soc Nephrol 2017
  3. Puliyanda et al., Pediatric Transplantation 2020
  4. Bromberg et al., J Appl Lab Med 2017
  5. Bu et al., Kidney International 2021
  6. CareDx Test Information: AlloSure Kidney
Synonyms
AlloSure, CareDx, dd-cfDNA, Donor-Derived cfDNA
Components
Code Name
RDDCFD Allosure Kidney Tx Recipient dd cfDNA
RDCFDP Allosure dd cfDNA Percent
RIPT AlloSure dd cfDNA Interval Post Tx
RDDCI AlloSure dd cfDNA Interpretation
RDDCC AlloSure dd cfDNA Comment

Interpretation

Method

Next Generation Sequencing (NGS)

Reference Range
See individual components
Ref. Range Notes

AlloSure Result Interpretation:

>1.0% dd-cfDNA is associated with a probability of active rejection.²³
0.21 % dd-cfDNA is the median observed in a reference population of stable recipients.⁴

AlloSure RCV (Relative Change Value) Interpretation:

>61% increase in AlloSure Result from prior result exceeds the biological variability observed in the reference population.⁴
>149% increase in AlloSure Result from prior result may indicate a high likelihood of allograft injury.⁵
References
  1. Grskovic et al., J Mol Diagn 2016
  2. Bloom et al., J Am Soc Nephrol 2017
  3. Puliyanda et al., Pediatric Transplantation 2020
  4. Bromberg et al., J Appl Lab Med 2017
  5. Bu et al., Kidney International 2021
  6. CareDx Test Information: AlloSure Kidney

Ordering & Collection

Specimen Type
Blood
Collection

Collect 20 mL whole blood in 2 Streck Cell-Free DNA BCT® tubes (tan).

  • A kit is not required for collection. If CareDx AlloSure kits are not available at the draw site, lab staff may use Streck tubes on hand.
  • Fill tubes completely and mix by gently inverting 8-10 times.
    • Note: For difficult collections, one full Streck tube is preferred over two partially filled tubes.
  • Ensure that the labels do not obstruct the expiration date on the tubes; they must be visible or the samples will be rejected.
Handling Instructions

Outside Laboratories: This test is offered to UW Medicine patients only. Outside laboratories should arrange for testing directly with CareDx.

Quantity
Requested: 20 mL whole Blood (2 full Streck tubes)
Minimum: 8 mL whole blood in one Streck tube

Processing

Receiving Instructions

Store whole blood at room temperature.

UWNC (Neighborhood Clinics): All orders must be forwarded to UW-MT for processing. Do not ship samples directly to CareDx or return samples/kits to patients.

Sendouts:

  • Label the tubes and the Epic order slip 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 a Sunquest accession label to the EPIC requisition.
  • Package samples in the provided CareDx shipping kit and ship at ambient temperature.
  • Samples may be shipped Monday through Friday. CareDx accepts Saturday deliveries.

Stability: Ambient (Required): 7 days; Refrigerated: Not Acceptable; Frozen: Not Acceptable.

Misc Sendout

Performance

Lab Department
Frequency
Available STAT?
No
Performing Location(s)
Sendout CareDx
888-255-6627

3260 Bayshore Blvd.
Brisbane, CA 94005

Billing & Coding

LOINC
19146-0