Available Stat

No

Performing Lab

CareDx

Methodology

Targeted Next Generation Sequencing

Reported

3-5 days

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

Sample Type

Whole blood

Collect

Streck Cell-Free DNA BCT® (Streck Tube): AlloSure (Brown Tubes)

Amount to Collect

10 mL fpr AlloSure

Minimum Volume

10 mL fpr AlloSure

Remarks

Collection kit is required for this testing. Kits stocks are limited at draw sites, if possible, patients should bring kit from the ordering clinic.

Mix the tubes after drawing by gently inverting them back and forth 10 times.

Label with patient’s name, the date and time of collection, and RN or Phlebotomist initials. 

Stability (from collection to initiation)

AlloSure - 7 days

Rejection Criteria

Frozen samples. Hemolysis.

Test Code

ALLOS

Sendout

Yes

Performing Lab

CareDx

Specimen Preparation

Collection kit is required for processing. After collection kit is to be shipped from drawing location.

Minimum Volume

10 mL fpr AlloSure

Rejection Criteria

Frozen samples. Hemolysis.

Stability (from collection to initiation)

AlloSure - 7 days

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

CPT Codes

81479

Available Stat

No

Test Code

ALLOS

Performing Lab

CareDx

Sendout

Yes

Methodology

Targeted Next Generation Sequencing

Remarks

Collection kit is required for this testing. Kits stocks are limited at draw sites, if possible, patients should bring kit from the ordering clinic.

Mix the tubes after drawing by gently inverting them back and forth 10 times.

Label with patient’s name, the date and time of collection, and RN or Phlebotomist initials. 

Collect

Streck Cell-Free DNA BCT® (Streck Tube): AlloSure (Brown Tubes)

Amount to Collect

10 mL fpr AlloSure

Sample Type

Whole blood

Minimum Volume

10 mL fpr AlloSure

Rejection Criteria

Frozen samples. Hemolysis.

Specimen Preparation

Collection kit is required for processing. After collection kit is to be shipped from drawing location.

Stability (from collection to initiation)

AlloSure - 7 days

Reported

3-5 days

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

CPT Codes

81479
Ordering

Available Stat

No

Performing Lab

CareDx

Methodology

Targeted Next Generation Sequencing

Reported

3-5 days

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.
Collection

Sample Type

Whole blood

Collect

Streck Cell-Free DNA BCT® (Streck Tube): AlloSure (Brown Tubes)

Amount to Collect

10 mL fpr AlloSure

Minimum Volume

10 mL fpr AlloSure

Remarks

Collection kit is required for this testing. Kits stocks are limited at draw sites, if possible, patients should bring kit from the ordering clinic.

Mix the tubes after drawing by gently inverting them back and forth 10 times.

Label with patient’s name, the date and time of collection, and RN or Phlebotomist initials. 

Stability (from collection to initiation)

AlloSure - 7 days

Rejection Criteria

Frozen samples. Hemolysis.
Processing

Test Code

ALLOS

Sendout

Yes

Performing Lab

CareDx

Specimen Preparation

Collection kit is required for processing. After collection kit is to be shipped from drawing location.

Minimum Volume

10 mL fpr AlloSure

Rejection Criteria

Frozen samples. Hemolysis.

Stability (from collection to initiation)

AlloSure - 7 days
Result Interpretation

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.
Administrative

CPT Codes

81479
Complete View

Available Stat

No

Test Code

ALLOS

Performing Lab

CareDx

Sendout

Yes

Methodology

Targeted Next Generation Sequencing

Remarks

Collection kit is required for this testing. Kits stocks are limited at draw sites, if possible, patients should bring kit from the ordering clinic.

Mix the tubes after drawing by gently inverting them back and forth 10 times.

Label with patient’s name, the date and time of collection, and RN or Phlebotomist initials. 

Collect

Streck Cell-Free DNA BCT® (Streck Tube): AlloSure (Brown Tubes)

Amount to Collect

10 mL fpr AlloSure

Sample Type

Whole blood

Minimum Volume

10 mL fpr AlloSure

Rejection Criteria

Frozen samples. Hemolysis.

Specimen Preparation

Collection kit is required for processing. After collection kit is to be shipped from drawing location.

Stability (from collection to initiation)

AlloSure - 7 days

Reported

3-5 days

Additional Information

The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

CPT Codes

81479