AlloSure Kidney Transplant Monitoring


Abbrev Code:ALLSUR   
Order Code:LAB8064Order Name:AlloSure Kidney Transplant Monitoring
Synonyms:dd-cfDNA; Kidney Transplant Rejection
Methodology:Next generation sequencing
CPT Codes: 81479 x1
Turnaround Time:Specimens are sent to the reference laboratory Mon-Fri; results are reported within 5 days.
Associated Links:

AlloSure Specimen Collection


Collection Instructions

Specimen:Blood
Optimal Volume:20 mL
Minimum\Peds Volume:10 mL
Container:Brown/Black Streck tube provided in collection kit available from Sendout lab or CSC lab
Collection Instructions:Kit containing special brown/black Streck cell-free tubes. Draw using a 21G or larger needle after any EDTA tubes were drawn (order of draw); ensure there is no backflow of tube contents. Tubes must be filled completely and inverted 8-10 times.
Do not cover expiration date with patient label.
Patient Preparation: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. Clinical validity of the AlloSure test was established in single-kidney transplant recipients who were 18 year of age or older and at least two weeks post-transplant.
Causes for Rejection:Expired Streck collection container. Refrigerated or frozen temperatures.


Processing and Shipping

Specimen Processing:Do not process. Store at room temperature.
Shipping Instructions:Ship at room temperature. Protect from temperature extremes.
Stability:7 days at room temperature.
Test Performed at or Referral Lab Lab Sendouts  (CareDx)


Interpretive

Reference Range:By report
Limitations:Allosure should not be used within:
  • 30 days after a blood transfusion that contains white blood cells (washed or leukocyte-depleted RBCs are acceptable).
  • 24 hours following a biopsy


DO NOT USE Allosure testing for:
  • Recipients of transplanted organs other than kidney
  • Recipients of a transplant from a monozygotic (identical) twin
  • Recipients of a bone marrow transplant
  • Recipients who are pregnant
  • Recipients who are under the age of 18 years
  • Recipients who are less than 14 days post-transplant
Use:AlloSure testing is intended to aid in the identification of kidney transplant recipients 18 years of age or older, with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.


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