Aids in clinical management of HIV-positive individuals.
Quantitative Flow Cytometry
New York DOH Approval Status
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 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
EDTA: Ambient: 72 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|
|Absolute CD4||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|
The CD4 cells are Helper T-cells expressing both CD3 and CD4. 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.
Laboratory Developed Test (LDT)
This test is specifically designed for enumerating the absolute cell counts of Helper T-cells 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.
|Component Test Code*||Component Chart Name||LOINC|
- Immune Status-Flow Cytometry
- CD4 Count
- Helper T-Cell count
- P. jiroveci prophylaxis determination