Ordering Recommendation
Evaluate for primary immunodeficiencies, including severe combined immunodeficiency, and monitor immune reconstitution following transplantation.
Mnemonic
Methodology
Quantitative Flow Cytometry
Performed
Sun-Sat
Reported
1-3 days
New York DOH Approval Status
Specimen Required
Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin). Hemogard tubes are preferred for laboratory automation and safety.
Transport 4 mL whole blood. (Min: 0.5 mL)
CRITICAL ROOM TEMPERATURE.
Clotted or hemolyzed specimens.
Specimens must be analyzed within stability times provided. Some medication may affect immunophenotyping results and should be provided on the patient test request form.
EDTA: Ambient: 72 hours; Refrigerated: Unacceptable; Frozen: Unacceptable; Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
New York State Clients: Same as the above.
Reference Interval
Test Number |
Components |
Reference Interval |
||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Absolute CD19 |
|
|||||||||||||||||||||||||
% Natural Killer Cells |
|
|||||||||||||||||||||||||
Absolute Natural Killer Cells |
|
|||||||||||||||||||||||||
Absolute CD3 |
|
|||||||||||||||||||||||||
% CD3 |
|
|||||||||||||||||||||||||
Absolute CD4 |
|
|||||||||||||||||||||||||
Absolute CD8 |
|
|||||||||||||||||||||||||
% CD4 |
|
|||||||||||||||||||||||||
% CD8 |
|
|||||||||||||||||||||||||
% CD19 |
|
|||||||||||||||||||||||||
CD4:CD8 Ratio |
|
Interpretive Data
The CD4 cells are Helper T-cells expressing both CD3 and CD4. The CD8 cells are Cytotoxic T-cells expressing both CD3 and CD8. The B-cells express CD19, but not CD3. The NK-cells express either CD16 or CD56 (or both) but not CD3. CD3, CD4, CD8, CD19 and NK-cell percentages are reported as a percent of total lymphocytes. CD4 T-cell levels are a criterion for categorizing HIV-related clinical conditions by the CDC's classification system for HIV infection. The measurement of CD4 T-cell levels has been used to establish decision points for initiating P. jirovecii prophylaxis, antiviral therapy and to monitor the efficacy of treatment. The Public Health Service (PHS) has recommended that CD4 T-cell levels be monitored every 3 to 6 months in all HIV-infected persons.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Modified FDA
Note
This assay is designed for enumerating the percent and absolute cell counts of lymphocyte subsets in lysed whole blood. Whole blood is added to fluorochrome-labeled antibodies that bind specifically to cell surface antigens on lymphocytes. After incubation, lysing and fixation, percent and absolute counts are enumerated utilizing an internal quantitation standard. Additional CBC data is not required.
During HIV infection, antiviral therapy is often initiated when the absolute CD4 count drops below 500 cells/µL. When the absolute CD4 count drops below 200 cells/µL, therapeutic prophylaxis against PCP and other opportunistic infections may be initiated. When the absolute CD4 count drops below 100 cells/µL, prophylaxis against Mycobacterium avium complex is recommended.
For longitudinal studies involving serial monitoring, specimen collections should be performed at the same time of day.
Hotline History
CPT Codes
86355; 86357; 86359; 86360
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0095618 | Lymphocyte Subset Panel 5 Information | 48767-8 |
0095700 | Absolute CD19 | 15195-1 |
0095701 | % Natural Killer Cells | 32519-1 |
0095702 | Absolute Natural Killer Cells | 20604-5 |
0095902 | Absolute CD3 | 8122-4 |
0095903 | % CD3 | 20599-7 |
0095906 | Absolute CD4 | 24467-3 |
0095911 | Absolute CD8 | 14135-8 |
2012857 | % CD4 | 8123-2 |
2012858 | % CD8 | 32518-3 |
2012859 | % CD19 | 20593-0 |
2012860 | CD4:CD8 Ratio | 54218-3 |
Aliases
- CD3, CD4, CD8, CD19 absolute count, NK cells absolute count
- Helper T-Cell count
- Helper T-cells, Cytotoxic T-cells and NK-cells count
- Immune Status-Flow Cytometry
- Immunosuppressive therapy monitoring for immunocompromised
- P. jiroveci prophylaxis
- T-Cell Immunodeficiency Profile