HIV-1 Antigen & HIV-1/HIV-2 Antibody
HIV-1 Antigen and HIV-1 / HIV-2 Antibody (Human Immunodeficiency Virus) with Reflex to HIV-1/HIV-2 Antibody Differentiation
Brief Description of Test
Specimens will be screened by a fourth generation CMIA test for the qualitative detection of HIV-1 p24 antigen, and IgM and IgG antibodies to HIV-1 and/or HIV-2.
Any repeatedly reactive CMIA specimen will be tested with the Geenius assay that differentiates antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/HIV-2).
If the Geenius Interpretation is Negative, HIV-1 Indeterminate, HIV-2 Indeterminate, or HIV Indeterminate, the specimen will be sent out for an HIV nucleic acid test (NAT) if specimen requirements are met.
This multi-test algorithm is recommended by the Centers for Disease Control and Prevention (CDC) and has been adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV.
This test is not intended for use in screening blood or plasma donors. This test has not been FDA approved for children less than 2 years of age or for cadaveric specimens.
Chemiluminescent Microparticle Immunoassay (CMIA) / Immunochromatographic
One 6 mL red top vacutainer tube or EDTA, heparin, serum separator (SST)
6 mL of whole blood or 1.5 mL of serum or plasma
Store specimens at 2-8°C for 7 days.
After 7 days, the serum/plasma must be removed from clot, red blood cells, or separator gel and stored frozen at -20°C or colder
Specimens should be sent daily or next working day
Transport in SPHL shipping containers at room temperature or with coolant (if available)
CMIA: Reactive, Non-Reactive, Unsatisfactory
Geenius Interpretation: HIV-1 Positive, Negative, HIV-1 Indeterminate, HIV Positive (Untypable), HIV-2 Positive, HIV-2 Indeterminate, HIV Indeterminate, HIV-2 Positive with HIV-1 cross reactivity, Unsatisfactory
Components: HIV Ag/Ab, Combo
Reference Interval: Non-Reactive, Negative
No Name on Specimen
Name on Specimen Does Not Match Name on Request Form
Quantity Not Sufficient
In Transit for More Than 10 Days
Hemolysis and bacterial contamination
1-3 days after receipt of specimen
For private entities, there is a $10 handling fee.
87389 HIV-1 Ag/HIV-1 and HIV-2 Ab; if reflexed, add HIV-1 and HIV-2 Antibody Differentiation 86701 and 86702
HIV Ag/Ab Combo: 56888-1, Geenius: 80203-3 (HIV-1 Ab: 68961-2, HIV-2 Ab: 81641-3)
Testing alone cannot be used to diagnose AIDS, which is a clinical syndrome. The diagnosis of AIDS must be established clinically. A nonreactive result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. Nonreactive results may be because antigen and antibody levels are below the limit of detection of this assay.