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 CIA, 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.
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/Antibody Negative
2013107 Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental
Test Number
Components
Reference Interval
HIV-1 Antibody Negative
HIV-2 Antibody Negative

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).

No compliance statements are in use for this test.

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.

Hotline History
N/A
CPT Codes

87389; if reflexed, add 86701; 86702

Components
Component Test Code* Component Chart Name LOINC
2012675 HIV 1,2 Combo Antigen/Antibody 56888-1
* 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
Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA with Reflex to HIV-1/HIV-2 Antibody Differentiation, Supplemental