Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA with Reflex to HIV-1/HIV-2 Antibody Differentiation, Supplemental
Also known as: HIVAGABGE
Use
This 4th generation test screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. It is used for detecting HIV infection, though it does not constitute the full 2014 CDC recommended algorithm for HIV diagnosis. Results that are repeatedly reactive will reflex to an HIV-1/HIV-2 antibody differentiation test, which helps in distinguishing between HIV-1 and HIV-2 antibodies as recommended by the CDC and adopted by the CLSI.
Special Instructions
This assay should not be used for blood donor screening, associated reentry protocols, or for screening human cells, tissues, and cellular- and tissue-based products. The reflexed differentiation test will incur additional charges, and further testing might be recommended based on results. All workflow and procedures adhere to FDA compliance.
Limitations
The test cannot distinguish between the presence of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody. It should not be utilized for screening blood donors or products derived from human tissues and cells. Reactivity might be influenced by particulate material, hemolysis, or heat inactivation of specimens which could lead to assay rejection.
FDA ApprovedNew York Approved
Methodology
Immunoassay (CLIA)
Biomarkers
LOINC Codes
- 56888-1
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
0.75 mL
Container
Serum separator tube (SST), also lavender (EDTA) or pink (K2EDTA) tube
Collection Instructions
Separate from cells ASAP or within 2 hours of collection and transfer to an ARUP standard transport tube.
Patient Preparation
N/A
Storage Instructions
Frozen
Causes for Rejection
Specimens containing particulate material, severely hemolyzed, or heat-inactivated specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 24 hours |
| Refrigerated | 7 days |
| Frozen | 8 months |