Assay Sheet
Test ID
9000 ImmuKnow
CPT Code
86353
82397
Description
ImmuKnow is an immune cell function assay that detects cell-mediated immunity in an immunosuppressed population.1
Procedure
ImmuKnow technology combines cell stimulation, cell selection, and quantification of metabolic markers (ATP) to measure cell-mediated immunity. ImmuKnow measures early response to stimulation by detecting intracellular ATP synthesis in CD4 cells selected from blood by monoclonal antibody-coated magnetic beads. The amount of ATP present in stimulated blood specimens is a measure of lymphocyte activity. Since the CD4 lymphocytes orchestrate cell-mediated immunity responses through immunoregulatory signaling, the measurement of CD4 activation reflects the degree of immune function.1
Specimens
Whole Blood: 2-3 ml submitted in a sodium heparin (green top) tube; Ship at room temperature, priority overnight Monday - Friday.
Sensitivity
The limit of ATP detection of ImmuKnow is 1 ng/ml.1
Assay ATP Level Ranges
The ATP level ranges for ImmuKnow were established by testing 155 apparently healthy adults and 127 transplant recipients. A cumulative frequency of differences was used to select the ATP levels that give the best balance of results between immunosuppressed and non-immunosuppressed individuals. The cutoffs for the ATP level ranges are 225 and 525 ng/ml.1
Interpretation of Results
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| <225 |
Low Immune Response
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| 226-524 |
Moderate Immune Response
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| >525 |
Strong Immune Response
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Results of the ImmuKnow assay should be used in conjunction with clinical presentation, medical history, and other clinical indicators when establishing the immune status of a patient. This is a qualitative assay; therefore, the result does not quantify the level of immunosuppression.1
Turnaround Time
Within 24 hours of receiving specimen
DOWNLOAD ASSAY SHEET
AS18-0108 For in vitro diagnostic use.
ImmuKnow is a registered trademark of Cylex Incorporated.
ImmuKnow technology is patented by Cylex Incorporated.
1. ImmuKnow Package Insert (Cylex Incorporated Immune Cell Function Assay)
AS18-0108
Collection & Shipping
Turnaround Time: Within 24 hours of specimen receipt at ViraCor
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9000 ImmuKnow®
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Whole Blood: 2‐3 ml collected in a sodium heparin (green top) tube. Maintain ambient temperature by shipping the specimen in 2 inch thick styrofoam with specimen surrounded by ambient temperature gel packs Specimen must arrive at ViraCor within 30 hours of collection.
Ship ambient for priority overnight delivery Monday‐Friday.
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- All specimens must be labeled with patient's name and collection date.
- A ViraCor Test Request Form must accompany each specimen.
- Ship specimens FedEx Priority Overnight to: ViraCor Laboratories | 1001 NW Technology Dr | Lee's Summit MO 64086
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PCR tests are performed pursuant to a license agreement with Roche Molecular Systems Inc.
ImmuKnow is a registered trademark of Cylex Incorporated.
Respiratory Viral Panel is a product of Luminex Corporation.
ImmuKnow is an FDA cleared for in vitro diagnostic use immune cell function assay that detects cell-mediated immunity in an immunosuppressed population.