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Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA, Reflexive Panel
Ordering Recommendation
In accordance with the CDC's recommended HIV testing algorithm, this fourth-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-1/2 antibody differentiation test. Negative or indeterminate results for HIV-1/2 antibody differentiation are confirmed with a quantitative nucleic acid amplification test (NAAT).
New York DOH Approval Status
Specimen Required
Lavender (EDTA) or pink (K2EDTA).
Separate from cells within 24 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.
Frozen.
Serum. Heparinized or citrated plasma specimens. Plasma preparation tube. Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens.
After separation from cells: Ambient: 24 hours (CRITICAL: SHIP FROZEN); Refrigerated: 72 hours; Frozen: 3 months (avoid repeated freeze/thaw cycles)
Methodology
Qualitative Chemiluminescent Immunoassay (CLIA)/Qualitative Immunoassay/Quantitative Transcription-Mediated Amplification (TMA)
Performed
Sun-Sat
Reported
1-2 days
Reference Interval
Effective November 12, 2018
| Test Number |
Components |
Reference Interval |
|---|---|---|
| HIV 1,2 Combo Antigen/Antibody | Negative |
Interpretive Data
This test should not be used for blood donor screening, associated reentry protocols, or for screening human cells, tissues, and cellular- and tissue-based products (HCT/P).
FDA
Note
The fourth-generation screen test is for the simultaneous qualitative detection of human iImmunodeficiency 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 (Ab), or HIV-2 Ab.
If the HIV-1,2 combo antigen/Ab 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 Abs. Results for each type are reported.
If the HIV-1/2 Ab differentiation immunoassay is Negative or Indeterminate, then the Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma will be added. Additional charges apply.
This multitest 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 https://arupconsult.com/content/human-immunodeficiency-virus).
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 NAAT, Plasma (ARUP test code 2012669); Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma (ARUP test code 3000867).
Hotline History
CPT Codes
87389; if reflexed, add 86701 and 86702; if reflexed, add 87536
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2012675 | HIV 1,2 Combo Antigen/Antibody | 56888-1 |
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
