Evaluate for primary immunodeficiencies, including severe combined immunodeficiency, and monitor immune reconstitution following transplantation.
Quantitative Flow Cytometry
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
New York State Clients: EDTA: Ambient: 30 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Effective November 16, 2015
Reports include age appropriate reference intervals and interpretation.
Reference Interval Notes:
Pediatric reference values (0 - 6 days up to 10 - 15 years) taken from Scandinavian Journal of Immunology 2012; 75, 436-444.
Adult and Geriatric (16 - 64 and 65 plus years) ranges were developed in-lab.
|Test Number||Components||0-6 days
||1 week-1 month||2-4 months||5-8 months||9-14 months||15-23 months||2-4 years||5-9 years||10-15 years||16-64 years||65 years or older|
|% CD3||38-88%||55-90 %||49-97 %||49-95%||56-87%||36-92%||52-92%||55-97%||52-90%||62-87%||62-89%|
|1400-6800 cells/µL||1900-8400 cells/µL||2200-9200 cells/µL||1400-11500 cells/µL||2400-8300 cells/µL||700-8800 cells/µL||850-4300 cells/µL||770-4000 cells/µL||850-3200 cells/µL||570-2400 cells/µL||660-2200 cells/µL|
|% CD4||26-62 %||39-69 %||37-69 %||27-81%||25-86%||16-91%||25-66%||26-61%||20-65%||32-64%||35-68%|
|1000-4800 cells/µL||1500-6000 cells/µL||1600-6500 cells/µL||1000-7200 cells/µL||1300-7100
|400-7200 cells/µL||500-2700 cells/µL||400-2500 cells/µL||400-2100 cells/µL||430-1800 cells/µL||490-1600 cells/µL|
|300-3400 cells/µL||200-5400 cells/µL||400-4100 cells/µL||200-2800 cells/µL||200-1800 cells/µL||200-1700 cells/µL||300-1300 cells/µL||210-1200 cells/µL||150-1050 cells/µL|
|140-2000 cells/µL||180-3500 cells/µL||520-2300 cells/µL||130-6300 cells/µL||110-7700 cells/µL||160-3700 cells/µL||180-1300 cells/µL||100-800 cells/µL||120-740 cells/µL||91-610 cells/µL||74-510 cells/µL|
|Absolute NK-cells||500-3100 cells/µL||140-1900 cells/µL||97-2000 cells/µL||68-3900 cells/µL||71-3500 cells/µL||55-4000 cells/µL||61-510 cells/µL||70-590 cells/µL||92-1200 cells/µL||78-470 cells/µL||74-620 cells/µL|
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.
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.
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.
86355; 86357; 86359; 86360
|Component Test Code*||Component Chart Name||LOINC|
|0095618||Lymphocyte Subset Panel 5 Information||48767-8|
|0095701||% Natural Killer Cells||32519-1|
|0095702||Absolute Natural Killer Cells||20604-5|
- 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