Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by ELISA, Reflexive Panel
Ordering Recommendation

2014 CDC Recommended Algorithm for Laboratory Diagnosis of HIV infection. 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 are confirmed with an HIV-1/ HIV-2 antibody differentiation test. Negative or indeterminate results for HIV-1/2 antibody differentiation are confirmed with a quantitative PCR test.

Qualitative Enzyme-Linked Immunosorbent Assay/Qualitative Immunoassay/Quantitative Polymerase Chain Reaction
Mon, Wed-Sat
1-3 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
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Lavender (EDTA), pink (K2EDTA). 
Specimen Preparation
Separate plasma from cells ASAP or within 2 hours of collection. Transfer 3 mL plasma into an ARUP Standard Transport Tube dedicated only for HIV testing. (Min: 2 mL) Remove particulate material. 
Storage/Transport Temperature
Unacceptable Conditions
Serum. Heparinized or citrated plasma specimens. Specimens submitted in plasma preparation tube. Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens. 
This test requires a dedicated tube of EDTA plasma submitted only for HIV testing. 
After separation from cells: Ambient: Unacceptable; Refrigerated: 6 days; Frozen: 6 weeks (avoid repeated freeze/thaw cycles) 
Reference Interval
Test NumberComponentsReference Interval
HIV 1,2 Combo Antigen/AntibodyNegative
HIV-1 AntibodyNegative
HIV-2 AntibodyNegative
0055598Human Immunodeficiency Virus 1 by Quantitative PCRNot detected

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

The fourth-generation ELISA 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.

If the HIV-1,2 Combo Antigen/Antibody screen is repeatedly reactive, then the HIV-1/2 Ab Differentiation Immunoassay will be performed. Additional charges apply. The HIV-1/2 Ab Differentiation Immunoassay confirms and discriminates between HIV-1 and HIV-2 antibodies. Results for each type are reported.

If the HIV-1/2 Ab Differentiation Immunoassay is Negative or Indeterminate, then the Human Immunodeficiency Virus 1 by Quantitative PCR will be added. Additional charges apply.

This multi-test algorithm was is recommended proposed by the Centers for Disease Control and Prevention (CDC) and adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV (refer to

Refer to the following tests for additional information regarding Performed or Reported times, Interpretive Data and Notes for the reflex tests of this panel:
Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental with Reflex to HIV-1 Quantitative PCR (2012669);
Human Immunodeficiency Virus 1 by Quantitative PCR (0055598)
CPT Code(s)
87389; if reflexed, add 86701 and 86702; if reflexed, add 87536
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.
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antibodies, Preliminary Test With Confirmation
  • 4th generation, Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody
  • Fourth generation HIV
  • HIV 1,2 Combo Antigen/Antibody
  • HIV Diagnosis
  • HIV-1/2 Antigen and Antibodies
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test