Lymphocyte Subset Panel 1 - CD4 Absolute Count Only
0095854
Ordering Recommendation
Aids in clinical management of HIV-positive individuals.
Mnemonic
ABS4
Methodology
Quantitative Flow Cytometry
Performed
Sun-Sat
Reported
1-2 days  
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
Time SensitiveTime Sensitive

Specimen Required
Patient Preparation
  
Collect
Lavender Hemogard (EDTA), pink Hemogard (K2EDTA), or green Hemogard (sodium or lithium heparin). Hemogard tubes are preferred for laboratory safety.  
Specimen Preparation
Transport 4 mL whole blood. (Min: 0.5 mL)  
Storage/Transport Temperature
CRITICAL ROOM TEMPERATURE.  
Unacceptable Conditions
Frozen or refrigerated specimens. Specimens older than 72 hours in EDTA or 48 hours in heparin. Clotted or hemolyzed specimens.  
Remarks
Specimens must be analyzed within 72 hours of collection in EDTA or within 48 hours of collection in heparin. 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
Ambient: 72 hours in EDTA, 48 hours in heparin; Refrigerated: Unacceptable; Frozen: Unacceptable  
Reference Interval
Effective November 18, 2013
Reports include age appropriate reference intervals and interpretation.
 
Age: 0-​11 months Age: 12-​23 months Age: 2 years and older
1580-​4850 cells/µL 1020-​3600 cells/µL 430-​1800 cells/µL
Interpretive Data
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. jiroveci 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 three to six months in all HIV-infected persons.

See Compliance Statement B: www.aruplab.com/CS
Statement B: 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 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.
CPT Code(s)
86361
Components
Component Test Code*Component Chart NameLOINC
0095854Absolute CD424467-3
* 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
  • Immune Status-Flow Cytometry
  • CD4
  • CD4 Count
  • Helper T-Cell count
  • P. jiroveci prophylaxis determination