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Test Code HIVCOM Human Immunodeficiency Virus (HIV) 1 and 2 Antibody

Important Note

The VITROS HIV is not intended for newborn screening or for use with cord blood specimens or from individuals less than 2 years of age.

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