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Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA, Reflexive Panel
2012674
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.

Mnemonic
HIV PANEL
Methodology
Qualitative Chemiluminescent Immunoassay/Qualitative Immunoassay/Quantitative Polymerase Chain
Performed
Sun-Sat
Reported
1-3 days
N/A
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
 
Collect
Lavender (EDTA) or pink (K2EDTA). 
Specimen Preparation
Separate from cells ASAP or within 2 hours of collection. Transfer 3 mL plasma into an ARUP Standard Transport Tube. (Min: 2 mL) Remove particulate material. This test requires a dedicated transport tube submitted only for HIV testing. 
Storage/Transport Temperature
Frozen. 
Unacceptable Conditions
Serum. Heparinized or citrated plasma specimens. Plasma preparation tube. Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens. 
Remarks
 
Stability
After separation from cells: Ambient: Unacceptable; Refrigerated: 6 days; Frozen: 6 weeks (avoid repeated freeze/thaw cycles) 
Reference Interval
Test Number
Components
Reference Interval
 HIV 1,2 Combo Antigen/AntibodyNegative
2012669Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental, with Reflex to HIV-1 Quantitative PCR
Test NumberComponentsReference Interval
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).

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.

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 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 (refer to http://www.arupconsult.com/Topics/HIV.html).

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
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
  • 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