Sign in →

Test Code ALLOM AlloMap

Important Note

This test can only be collected at Maine Medical Center and processed by MMC lab research coordinator.

Performing Laboratory

CareDx

Useful For

The AlloMap Test is indicated for heart transplant recipients:

  • 15 years of age or older
  • At least 2 months ( greater than 55 days) post-transplant

The performance characteristics of the AlloMap Test were established with samples from heart transplant recipients at least 15 years of age and at least 2 months (greater than 55 days) post-transplant at the time samples were collected.

 

Method Name

 

The AlloMap test is based on standard quantitative real-time polymerase chain reaction methodology (qRT-PCR)1 using RNA isolated from peripheral blood mononuclear cells (PBMC). A whole blood sample is collected in a BD Vacutainer CPT™ Cell Preparation tube (Becton Dickinson, NJ) with sodium citrate (CPT tube). PBMC are isolated, lysed and the released RNA is stabilized and frozen (PBMC lysate). Following shipment to the XDx CAP-Accredited laboratory in Brisbane, CA, RNA is then purified from the PBMC lysate. The cDNA is subsequently generated from the RNA for use in the AlloMap test. The AlloMap test is performed using general laboratory equipment and commercially available thermal cycling instruments configured for qRT-PCR testing. The AlloMap test is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap test Score that ranges from 0-40.

Reference Values

Blood is collected from the patient and subsequently processed, packaged and shipped frozen to the CareDx laboratory. At the CareDx laboratory, gene expression levels are determined via real time PCR for each of the test and control genes and converted to the AlloMap test Score. The AlloMap test Score is then reported to the physician, who determines the next steps for the patient.

Preferred Container

BD Vacutainer® CPT™ Cell Preparation Tubes with Sodium Citrate (CPT; BD # 362761). Store tubes at room temperature (18-25°C). Protect tubes from direct light. Shelf life at 18-25°C is printed on each individual tube. Check expiration date of each tube before use
 

Minimum Volume

Prepared spciamen from at least 6 ml blood drawn in BD Vacutainer® CPT™ Cell Preparation Tubes with Sodium Citrate

Specimen Collection and Handling

IMPORTANT: All processing must be completed at room temperature and the lysate from processed samples must be frozen within 3 hours of blood collection. Freeze the lysate at -15°C or colder, or on dry ice, and ship as soon as possible, ideally on the day the sample was collected, to CareDx for testing.

Specimen Stability Information

frozen at -15'C or colder within three hours of collection.

Performing Laboratory Location

CareDx, Inc.
3260 Bayshore Boulevard
Brisbane, CA 94005, USA
Tel 415 287 2401
Fax415 287 2456
www.caredx.com

Clinical Significance

Performed solely in the CareDx CAP-accredited clinical laboratory, the AlloMap test is a service that is intended to aid in the identification of heart transplant recipients 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.