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Time Sensitive

Ordering Recommendation

Absolute CD4 count is sufficient for routine HIV monitoring.

Mnemonic

TSHORT

Methodology

Quantitative Flow Cytometry

Performed

Sun-Sat

Reported

1-2 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

BAL specimens (refer to ARUP test code 0093420). 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

Test Number
Components
Reference Interval
  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

  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

The CD4 cells are Helper T-cells expressing both CD3 and CD4. The CD8 cells are Cytotoxic T-cells expressing both CD3 and CD8. CD3, CD4 and CD8 percentages are reported as a percent of total lymphocytes. CD4 T-cells levels are a criterion for categorizing HIV-related clinical conditions by 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

This test is designed for enumerating the percents 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, percents 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

86359; 86360

Components

Component Test Code* Component Chart Name LOINC
0095616 Lymphocyte Subset Panel 4 Information 48767-8
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
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 and CD4
  • Helper T-cell count
  • Immune Status-Flow Cytometry
  • P. jiroveci prophylaxis determination
  • T-Cell Immunodeficiency Short Profile
  • T4/T8
Lymphocyte Subset Panel 4 - T-Cell Subsets Percent and Absolute, Whole Blood