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Lymphocyte Subset Panel 3 - T-Cell Subsets (CD4 and CD8), Absolute Counts Only

ABS
Example Reports
Abnormal
Normal

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Time Sensitive

Ordering Recommendation

Absolute CD4 count is sufficient for routine HIV monitoring.

New York DOH Approval Status

This test is not New York state approved. Alternative testing that is New York approved is available. See Ordering Recommendations.

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.

Remarks

Specimens must be analyzed within stability times provided. Some medications may affect immunophenotyping results and should be listed on the patient test request form.
This test is not approved for New York State clients.

Stability

EDTA: Ambient: 72 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable

Methodology

Quantitative Flow Cytometry

Performed

Sun-Sat

Reported

1-2 days

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

  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

  Absolute CD4:CD8 Ratio
Age Reference Interval (cells/µL)
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. 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

This assay is designed for enumerating the 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, 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

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Components

Component Test Code* Component Chart Name LOINC
0095619 Lymphocyte Subset Panel 3 Information 48767-8
0095740 Absolute CD3 8122-4
0095741 Absolute CD8 14135-8
0095742 Absolute CD4:CD8 Ratio 54218-3
0095904 Absolute CD4 24467-3
* 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

  • Helper T cell count
  • Helper T-Cell count
  • Immune Status-Flow Cytometry
  • Lymphocyte Subset CD4 and CD8
  • Absolute CD3, CD4, CD8 count
  • P. jiroveci prophylaxis determination
  • Absolute CD4 and CD8
Lymphocyte Subset Panel 3 - T-Cell Subsets (CD4 and CD8), Absolute Counts Only