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Time Sensitive
Ordering Recommendation

Evaluate for primary immunodeficiencies, including severe combined immunodeficiency, and monitor immune reconstitution following transplantation.

Mnemonic
TIMMUNPAN
Methodology

Quantitative Flow Cytometry

Performed

Sun-Sat

Reported

1-3 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin). Hemogard tubes are preferred for laboratory automation and safety.

Specimen Preparation

Transport 4 mL whole blood. (Min: 0.5 mL)

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE.

Unacceptable Conditions

Clotted or hemolyzed specimens.

Remarks

Specimens must be analyzed within stability times provided. Some medication may affect immunophenotyping results and should be provided on the patient test request form.

Stability

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

Reference Interval

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%
Absolute
CD3
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%
Absolute
CD4
1000-4800 cells/µL 1500-6000 cells/µL 1600-6500 cells/µL 1000-7200 cells/µL 1300-7100
cells/µL
400-7200 cells/µL 500-2700 cells/µL 400-2500 cells/µL 400-2100 cells/µL 430-1800 cells/µL 490-1600 cells/µL
% CD8 5-37% 7-35% 6-41% 10-35% 7-58% 7-40% 9-49% 13-47% 14-40% 15-46% 10-46%
Absolute
CD8
200-2700 cells/µL 300-2700
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
CD4:CD8 Ratio 1.00-2.60 1.30-6.30 1.70-3.90 1.60-3.80 1.30-3.90 0.90-3.70 0.90-2.90 0.90-2.60 0.90-3.40 0.80-3.90 0.80-6.17
% CD19 3-30% 3-60% 8-33% 4-54% 3-77% 8-45% 8-39% 4-33% 7-24% 6-23% 5-21%
Absolute
CD19
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
% NK-cells 8-62% 3-23% 2-20% 2-36% 1-64% 1-96% 2-25% 2-31% 4-51% 4-26% 5-28%
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

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.

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

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
N/A
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
* 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
  • 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
Lymphocyte Subset Panel 5 - Total Lymphocyte Enumeration