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Recommendations when to order or not order the test. May include related or preferred tests.
Evaluate for primary immunodeficiencies, including severe combined immunodeficiency, and monitor immune reconstitution following transplantation.
Methodology
Process(es) used to perform the test.
Quantitative Flow Cytometry
Performed
Days of the week the test is performed.
Sun-Sat
Reported
Expected turnaround time for a result, beginning when ARUP has received the specimen.
1-3 days
New York DOH Approval Status
Indicates test has been approved by the New York State Department of Health.
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; Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable New York State Clients: Same as the above.
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.
Test Number
Components
Reference Interval
Absolute CD19
Age
Reference Interval (cells/µL)
0-6 days
140-2000
1 week-1 month
180-3500
2-4 months
520-2300
5-8 months
130-6300
9-14 months
110-7700
15-23 months
160-3700
2-4 years
180-1300
5-9 years
100-800
10-15 years
120-740
16-64 years
91-610
65 years or older
74-510
% Natural Killer Cells
Age
Reference Interval (Percent)
0-6 days
8-62
1 week-1 month
3-23
2-4 months
2-20
5-8 months
2-36
9-14 months
1-64
15-23 months
1-96
2-4 years
2-25
5-9 years
2-31
10-15 years
4-51
16-64 years
4-26
65 years or older
5-28
Absolute Natural Killer Cells
Age
Reference Interval (cells/µL)
0-6 days
500-3100
1 week-1 month
140-1900
2-4 months
97-2000
5-8 months
68-3900
9-14 months
71-3500
15-23 months
55-4000
2-4 years
61-510
5-9 years
70-590
10-15 years
92-1200
16-64 years
78-470
65 years or older
74-620
Absolute CD3
Age
Reference Interval (cells/µL)
0-6 days
1400-6800
1 week-1 month
1900-8400
2-4 months
2200-9200
5-8 months
1400-11500
9-14 months
2400-8300
15-23 months
700-8800
2-4 years
850-4300
5-9 years
770-4000
10-15 years
850-3200
16-64 years
570-2400
65 years or older
660-2200
% CD3
Age
Reference Interval (Percent)
0-6 days
38-88
1 week-1 month
55-90
2-4 months
49-97
5-8 months
49-95
9-14 months
56-87
15-23 months
36-92
2-4 years
52-92
5-9 years
55-97
10-15 years
52-90
16-64 years
62-87
65 years or older
62-89
Absolute CD4
Age
Reference Interval (cells/µL)
0-6 days
1000-4800
1 week-1 month
1500-6000
2-4 months
1600-6500
5-8 months
1000-7200
9-14 months
1300-7100
15-23 months
400-7200
2-4 years
500-2700
5-9 years
400-2500
10-15 years
400-2100
16-64 years
430-1800
65 years or older
490-1600
Absolute CD8
Age
Reference Interval (cells/µL)
0-6 days
200-2700
1 week-1 month
300-2700
2-4 months
300-3400
5-8 months
200-5400
9-14 months
400-4100
15-23 months
200-2800
2-4 years
200-1800
5-9 years
200-1700
10-15 years
300-1300
16-64 years
210-1200
65 years or older
150-1050
% CD4
Age
Reference Interval (Percent)
0-6 days
26-62
1 week-1 month
39-69
2-4 months
37-69
5-8 months
27-81
9-14 months
25-86
15-23 months
16-91
2-4 years
25-66
5-9 years
26-61
10-15 years
20-65
16-64 years
32-64
65 years or older
35-68
% CD8
Age
Reference Interval (Percent)
0-6 days
5-37
1 week-1 month
7-35
2-4 months
6-41
5-8 months
10-35
9-14 months
7-58
15-23 months
7-40
2-4 years
9-49
5-9 years
13-47
10-15 years
14-40
16-64 years
15-46
65 years or older
10-46
% CD19
Age
Reference Interval (Percent)
0-6 days
3-30
1 week-1 month
3-60
2-4 months
8-33
5-8 months
4-54
9-14 months
3-77
15-23 months
8-45
2-4 years
8-39
5-9 years
4-33
10-15 years
7-24
16-64 years
6-23
65 years or older
5-21
CD4:CD8 Ratio
Age
Reference Interval
0-6 days
1.00-2.60
1 week-1 month
1.30-6.30
2-4 months
1.70-3.90
5-8 months
1.60-3.80
9-14 months
1.30-3.90
15-23 months
0.90-3.70
2-4 years
0.90-2.90
5-9 years
0.90-2.60
10-15 years
0.90-3.40
16-64 years
0.80-3.90
65 years or older
0.80-6.17
Interpretive Data
Background information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.
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.
Compliance Category
Modified FDA
Note
Additional information related to the test.
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
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* 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
Other names that describe the test. Synonyms.
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
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