Test Code HIVCOM Human Immunodeficiency Virus (HIV) 1 and 2 Antibody
Infectious
Additional Codes
| EPIC | LAB4126 |
Clinical Significance
Acquired Immunodeficiency Syndrome (AIDS) is caused by at least two types of Human Immunodeficiency Viruses designated HIV-1 and HIV-2. In addition, some HIV-1 strains have been isolated from AIDS patients in West Africa and designated as HIV-1 subtype O. Serological studies have shown that antibodies may develop to epitopes present in the peptides of the viral core and glycoprotein envelope. While antibodies to HIV-1 and HIV-2 core peptides demonstrate considerable cross reactivity, the antibodies generated by the glycoprotein show less cross-reactivity.
The VITROS anti-HIV 1+2 test uses 4 recombinant antigens (HIV-1 Env 13, HIV-1 Env 10, HIV-1 p24,and HIV-2 Env AL) derived from HIV-1 core, HIV-1 envelope and HIV-2 envelope. HIV-1 Env 13, envelope SOD fusion protein, contains region from both gp 120 and gp 41. HIV-1 Env 10, envelope SOD fusion protein, contains a gp 41 region which extends beyond the C-terminus of Env 13. HIV-1 p24 is derived from full length core protein of HIV-1. HIV-1 Env AL, envelope SOD fusion protein, contains a region from gp 36 of HIV-2.
These antigens detect antibodies to HIV-1 and antibodies from HIV-2 in the same test. The use of these recombinant antigens improves test specificity by avoiding non-specific reactions due to cross-reaction with human cell proteins, which are present in cell lysates. The host organism for all four HIV recombinant antigens is S. cerevisiae (yeast).
Source: Vitros ECiQ, HIV c IFU. Pub. No. GEM1256 Version 2.0
Methodology
Immunometric bridging technique (Vitros ECiQ)
Sample Type
| Preferred Sample Type | |
|---|---|
| Inpatient: Yellow Top - Serum | |
|
|
Outpatient: Yellow Top and Lavender top |
| Acceptable Sample Type | |
|---|---|
| Green Top - PST Plasma | |
Centrifuge: Yes
Specimen Minimum Volume
0.5 mL Serum - Yellow top
0.8 mL EDTA plasma - Lavender top
Specimen Stability
Yellow/Red/Light Green Top Specimen Stability
| Temperature | Time |
|---|---|
| Ambient (18-25°C) | 8 hours |
| Refrigerated (2-8°C) (store) | 48 hours |
| Frozen (<-20°C) | 1 month |
(Reflex - Sendout) Lavender Top Specimen Stability
| Temperature | Time |
|---|---|
| Ambient (18-25°C) | N/A |
| Refrigerated (2-8°C) | 6 days |
| Frozen (<-20°C) (preferred) | 30 days |
Reference Ranges
Normal Range
Negative
Result Interpretations
| Assay (1st Run) | Normalized Signal | Interpretation | Assay Repeat (2nd/3rd) | Normalized Signal | Interpretation |
|---|---|---|---|---|---|
| HIV | <0.90 | Negative (N) | HIV | <1.00 | Negative (N) |
| ≥0.90 and <1.00 | Retest | ||||
| ≥1.00 | Reactive (VRE) | ≥1.00 | Reactive (VRE) |
NOTE: This is only a qualitative test for the detection of HIV 1 + 2. Samples that are "Reactive" will reflex testing for confirmation/differentiation. The reflex test, HIV-1 and HIV-2 Antibody Confirmation and Differentiation (HVDIP), is performed at Mayo Clinic Laboratories.
Samples with Total Protein >9g/dL may give falsely reactive results.
Rejection Criteria
| Hemolysis | N/A |
|---|---|
| Icterus | N/A |
| Lipemia | 1+, ultracentrifuge |
Availability
| Performed | STAT |
|---|---|
| 24/7 | Yes |
Performing Laboratory
MultiCare Yakima Memorial Hospital Laboratory
Mayo Clinic Laboratories (Reflex testing)
Lab Department
Chemistry
CPT Code
87389
LOINC
95523-7 HIV 1 and 2 An panel IA