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
- 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)
|Test Number||Components||Reference Interval|
|HIV 1,2 Combo Antigen/Antibody||Negative|
|0055598||Human Immunodeficiency Virus 1 by Quantitative PCR||Not detected|
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 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)
|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