Feedback
Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA with Reflex to HIV-1/HIV-2 Antibody Differentiation, Supplemental
2013333
Ordering Recommendation

• This 4th generation test screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. Repeatedly reactive HIV-1, 2 antigen/antibody screening results will reflex to an HIV-1/HIV-2 antibody differentiation test.
•This test does not complete the 2014 CDC Recommended Algorithm for Laboratory Diagnosis of HIV Infection. Preferred test is Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by ELISA, Reflexive Panel (2012674).

Mnemonic
HIVAGABGE
Methodology
Qualitative Chemiluminescent Immunoassay/Qualitative Immunoassay
Performed
Sun-Sat
Reported
1-2 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
N/A 
Collect
Serum Separator Tube (SST). Also acceptable: Lavender (EDTA) or Pink (K2EDTA). 
Specimen Preparation
Separate from cells ASAP or within 2 hours of collection. Transfer 1.5 mL serum into an ARUP Standard Transport Tube. (Min: 0.75 mL) Remove particulate material. 
Storage/Transport Temperature
Refrigerated. 
Unacceptable Conditions
Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens. 
Remarks
 
Stability
After separation from cells: Ambient: Unacceptable; Refrigerated: 1 week; Frozen: 8 months (avoid repeated freeze/thaw cycles) 
Reference Interval
Test Number
Components
Reference Interval
HIV 1,2 Combo Antigen/AntibodyNegative
2013107Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental
Test Number
Components
Reference Interval
HIV-1 AntibodyNegative
HIV-2 AntibodyNegative


Interpretive Data
This test should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P).

Note
The fourth-generation screen test is for the simultaneous qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2). Results of the screen cannot be used to distinguish between the presence of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody.

The reflexed HIV-1/ HIV-2 Antibody Differentiation test discriminates between HIV-1 and HIV-2 antibodies. Results for each type are reported.

If the HIV-1,2 Combo Antigen/Antibody screen is repeatedly reactive, then the HIV-1/ HIV-2 Antibody Differentiation test will be performed. Additional charges apply. A recommendation to order further testing on a separate specimen for HIV-1 Nucleic Acid will be made for certain results. This multi-test algorithm is recommended by the Centers for Disease Control and Prevention (CDC) and was adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV.
CPT Code(s)
87389; if reflexed, add 86701 and 86702
Components
Component Test Code*Component Chart NameLOINC
2012675HIV 1,2 Combo Antigen/Antibody56888-1
* 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
  • 4th generation
  • Fourth generation HIV
  • HIV 1,2 Combo Antigen/Antibody
  • HIV Diagnosis
  • HIV Geenius
  • HIV-1 & 2 Antibody Differentiation
  • HIV-1 Antibody by Geenius
  • HIV-1,2 Combo Antigen/Antibody
  • HIV-2 Antibody by Geenius
  • Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody