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.
- Patient Preparation
- Collect
- Lavender (EDTA) or Pink (K2EDTA).
- Specimen Preparation
- 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.
- 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: 72 hours; Frozen: 3 months (avoid repeated freeze/thaw cycles)
Test Number | Components | Reference Interval | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
  | HIV 1,2 Combo Antigen/Antibody | Negative | ||||||||||||
2012669 | Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental, with Reflex to HIV-1 Quantitative NAAT, Plasma | Effective November 12, 2018
|
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 (HIV-1) by Quantitative NAAT, Plasma 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 NAAT, Plasma (ARUP test code 2012669); Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma (ARUP test code 3000867).
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
2012675 | HIV 1,2 Combo Antigen/Antibody | 56888-1 |
- 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