Immune Cell Function
Test Summary
This non-pathogen-specific immune function assay detects cell-mediated immunity by measuring intracellular adenosine triphosphate (iATP) levels in stimulated CD4 lymphocytes. This test may be useful in assessing the immunosuppressive status of solid organ transplant (SOT) recipients to help predict the risk of infection and optimize immunosuppressive regimens [1,2].
The risk of infection after transplantation depends upon the epidemiologic exposures and the net state of immunosuppression [3]. Excessive immunosuppression increases the risk of infection; inadequate immunosuppression increases the risk of graft rejection. Because CD4 lymphocytes mediate cell-mediated immunity (CMI), quantification of CD4 activation may be helpful in assessing the immunosuppression status after SOT. Early responses of CD4 lymphocytes can be quantified by measuring iATP production in stimulated CD4 cells. By assessing CMI, this assay may help estimate the aggregate impact of multiple factors, such as the use of immune suppressants and underlying clinical conditions, on a patient's immune status [1,2].
This assay cannot be used as a diagnostic test for infection or graft rejection and does not replace diagnostic assays (eg, culture, viral load, and biopsy) to inform clinical decisions [2]. Without standardized strategies to simultaneously assess a patient's risk for infection and graft rejection, clinical judgment remains crucial for individualizing patient management. The value of this assay for assessing risk of infection [4] and rejection [4,5] in SOT recipients needs further study.
Results are most accurate if testing is performed on the day of blood draw. Performing the assay ≥1 day after the draw may lead to falsely low iATP levels [6].
The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.
References
1. ImmuKnow immune cell function assay. Eurofins Viracor. Accessed March 1, 2022. https://www.eurofins-viracor.com/clinical/our-testing/immuknow/
2. Kowalski RJ, et al. Transplantation. 2006;82(5):663-668.
3. Fishman JA. Am J Transplant. 2017;17(4):856-879.
4. Ling X, et al. Transplantation. 2012;93(7):737-743.
5. Rodrigo E, et al. Liver Transpl. 2012;18(10):1245-1253.
6. Suviolahti E, et al. Transplantation. 2012;94(12):1243-1249.
Aliases
- N/A
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Call for STAT transportation to lab
• Test available by prior arrangement only.
• Contact your local laboratory for specific directions.
• Special logistic arrangements must be made before ordering the test.
• Samples received exceeding 30 hours will be rejected.
• Only collect MONDAY - WEDNESDAY. Must arrive at Sandridge in AM on morning of collection. Do not collect the day before a holiday.
Patient Preparation
Storage
Transport Temperature
Specimen Stability
- Room temperature: 30 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
Other Acceptable Specimens
Unacceptable Specimens
Order Code
EPIC (Premier) Code
Includes
CPT Code
- 86352 - This test code is for non-New York patient testing. For New York patient testing use test code 17836X
Billing Code
- 700000
CPT Statement
Methodology
FDA Status
Physician Attestation of Informed Consent
Testing Laboratory
14225 Newbrook Drive
Chantilly VA, 20153
Reference Range
≤225 ng/mL ATP | Low Immune Cell Response | |
226-524 ng/mL ATP | Moderate Immune Cell Response | |
≥525 ng/mL ATP | Strong Immune Cell Response |
Setup Schedule / Expected Turnaround Time
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Call for STAT transportation to lab
• Test available by prior arrangement only.
• Contact your local laboratory for specific directions.
• Special logistic arrangements must be made before ordering the test.
• Samples received exceeding 30 hours will be rejected.
• Only collect MONDAY - WEDNESDAY. Must arrive at Sandridge in AM on morning of collection. Do not collect the day before a holiday.
Patient Preparation
Storage
Transport Temperature
Specimen Stability
- Room temperature: 30 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
Other Acceptable Specimens
Unacceptable Specimens
Billing
CPT Code
- 86352 - This test code is for non-New York patient testing. For New York patient testing use test code 17836X
Billing Code
- 700000
CPT Statement
Result Information
Methodology
Testing Laboratory
Reference Range
≤225 ng/mL ATP | Low Immune Cell Response | |
226-524 ng/mL ATP | Moderate Immune Cell Response | |
≥525 ng/mL ATP | Strong Immune Cell Response |