Lymphocyte Proliferation, Anti-CD3, Anti-CD28 and IL-2 Induced, by Flow Cytometry (24-Hr Critical Room Temp)

3001337
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Ordering Recommendation

Primarily for evaluating T-cell function in patients with suspected cellular immune dysfunction, such as primary and secondary immunodeficiencies. Other uses include monitoring lymphocyte recovery and competence after hematopoietic stem cell transplantation and monitoring lymphocyte function during immunosuppressive therapy. Not a first-level test; order after Lymphocyte Proliferation, Mitogen Induced, by Flow Cytometry (48-Hr Critical Room Temp) (3001321) has been performed.

Mnemonic
LPCD3 FLOW
Methodology

Cell Culture/Flow Cytometry

Performed

Thu, Fri

Reported

9-10 days

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Specimen Required
Patient Preparation

Collect control specimen from a healthy individual unrelated to patient.
Patient and control specimens must be collected ONLY on Wednesdays or Thursdays AND shipped directly to ARUP the same calendar day to meet the strict 24-hour stability requirement.

Collect

Green (sodium heparin) (patient) AND green (sodium heparin) (control) only on Wednesdays or Thursdays.

Specimen Preparation

: Transport 10 mL whole blood (patient) AND 10 mL whole blood (control) in original collection tubes. (Min: 7 mL (patient) AND 7 mL (control)). Infant Minimum: 3 mL (patient) AND 7 mL (control).
Do not refrigerate or freeze. LIVE LYMPHOCYTES REQUIRED.

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE.
Must be collected and shipped directly to ARUP the same calendar day.

Unacceptable Conditions

Refrigerated or frozen specimens.

Remarks

Do not collect or ship on, or the day before, holidays.

Stability

Ambient: 24 hours; Refrigerated: Unacceptable; Frozen: Unacceptable

Reference Interval
Anti-CD3 Anti-CD3/Anti-CD28 Anti-CD3/IL-2
CD45 Pos Cells 10.2% or greater 29.0% or greater 33.1% or greater
CD3 Pos Cells 13.5% or greater 24.3% or greater 36.1% or greater

Interpretive Data

This test measures T lymphocyte proliferation in response to stimulation with anti-CD3, anti-CD3/anti-CD28, and anti-CD3/Interleukin-2, determined by flow cytometry. Proliferating cells are detected by fluorescent labeling. Results are reported as percent proliferating cells of the total specific cell populations. This is a second-level test to be performed after Lymphocyte Proliferation to Mitogens (PHA, Con A, and PWM) by Flow Cytometry has been assessed.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Hotline History

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Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
04/01/2019
X
N/A
CPT Codes

86353 x3

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Components
Component Test Code* Component Chart Name LOINC
3001338 CD45+ Cell Proliferation by anti-CD3 81760-1
3001339 CD3+ Cell Proliferation by anti-CD3 81756-9
3001340 CD45+ Cell Prolif by anti-CD3/CD28 81759-3
3001341 CD3+ Cell Prolif by anti-CD3/CD28 81758-5
3001342 CD45+ Cell Prolif by anti-CD3 and IL-2 81755-1
3001343 CD3+ Cell Prolif by anti-CD3 and IL-2 81757-7
3001344 Lymphocyte Proliferation-AntiCD3, Interp 53810-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
Lymphocyte Proliferation, Anti-CD3, Anti-CD28 and IL-2 Induced, by Flow Cytometry (24-Hr Critical Room Temp)