|
|
| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HIV Ag/Ab Combo (CHIV)
Test CodeHIVAA
Preferred Specimen
1.0 mL Plasma (Lithium Heparin)
Minimum Volume
0.5 mL
Other Acceptable Specimens
Plasma (EDTA), Serum (Red top tube, Serum separator tube SST)
Instructions
Normal procedures for collecting and storing serum and plasma may be used for samples to be analyzed by this method.
Transport Container
Collection container
Transport Temperature
Room temperature
Specimen Stability
Room Temperature: 24 hours
Refrigerated: 14 days
Frozen: 8 months
Refrigerated: 14 days
Frozen: 8 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis
Methodology
The Atellica IM CHIV assay is a 2-step antigen/antibody sandwich immunoassay in which
antigens are bridged by antibody present in the patient sample and antigen in the sample is bridged by antibody present in the reagents. The Solid Phase contains a preformed complex of streptavidin-coated paramagnetic microparticles and biotinylated HIV‑1 and HIV‑2
recombinant antigens, group O peptide antigen, and biotinylated anti‑p24 antibody. This
reagent is used to capture anti‑HIV‑1 and/or HIV‑2 antibodies and/or HIV p24 antigen in the
patient sample. The Ancillary Lite Reagent and Lite Reagent contain acridinium-ester-labeled HIV‑1 and HIV‑2 recombinant antigens, group O peptide antigen, and acridinium-ester-labeled anti‑p24 antibodies used to detect anti‑HIV‑1 and/or HIV‑2 antibodies and/or p24 antigen bound to the Solid Phase in the sample.
A direct relationship exists between the amount of HIV antibody activity and/or HIV p24
antigen present in the specimen and the amount of relative light units detected by the
system. A result of reactive or nonreactive is determined according to the Index Value
established with the calibrators.
FDA Status
FDA Approved/Cleared
Setup Schedule
Daily
Report Available
Daily
Limitations
Interfering Substances
| Specimens that are … | Demonstrate ≤ 10% change in results … |
| Hemolyzed | Up to 500 mg/dL of hemoglobin |
| Lipemic | Up to 1000 mg/dL of triglycerides |
| Icteric | Up to 40 mg/dL of conjugated bilirubin |
| Icteric | Up to 40 mg/dL of unconjugated bilirubin |
| Hyper-IgG | Up to 60 mg/mL of Immunoglobulin G |
| Hyperproteinemic | Up to 12 g/dL of total protein |
| Hypoproteinemic | As low as 3.5 g/dL of protein |
Reference Range
Nonreactive (NR)
Clinical Significance
Human immunodeficiency virus is the causative agent of acquired immunodeficiency
syndrome (AIDS). Human immunodeficiency virus type 1 (HIV‑1) has been identified as the primary cause of acquired immunodeficiency syndrome (AIDS). This retrovirus, a member of the lentivirinae subfamily, is spread by sexual contact, exposure to infected blood or blood products, and perinatal transmission. Human immunodeficiency virus type 2 (HIV‑2) was isolated from AIDS patients in West Africa. These viruses share epitopes of the core proteins, but exhibit little or no cross-reactivity between the envelope glycoproteins.
Comparison of the nucleic acid sequences for HIV‑1 and HIV‑2 shows approximately 60%
homology in the conserved genes, such as gag and pol , and 30%–40% homology in less conserved regions. HIV‑1 has been subdivided into group M and group O. The routes of transmission of HIV‑1 and HIV‑2 are the same. However, the transmission and the viral replication rate are much lower in HIV‑2 infections. Clinical studies have shown that in
HIV‑2 infections there is a slower disease progression than in HIV‑1 infections. In HIV‑2
infections, there is a slower rate in the decline of CD4 T‑cells and reduced viremia. Individuals infected with HIV‑2 generally have a better clinical outcome. The Atellica IM CHIV assay uses yeast-recombinant-derived antigens corresponding to the viral envelope proteins. Recombinant antigens include an HIV‑1 envelope protein and an HIV‑2 envelope protein. A synthetic peptide is added for the detection of antibodies to HIV‑1 group O. The assay uses 3 monoclonal antibodies specific to HIV p24 antigen to capture and detect HIV p24 antigen in a sample.
syndrome (AIDS). Human immunodeficiency virus type 1 (HIV‑1) has been identified as the primary cause of acquired immunodeficiency syndrome (AIDS). This retrovirus, a member of the lentivirinae subfamily, is spread by sexual contact, exposure to infected blood or blood products, and perinatal transmission. Human immunodeficiency virus type 2 (HIV‑2) was isolated from AIDS patients in West Africa. These viruses share epitopes of the core proteins, but exhibit little or no cross-reactivity between the envelope glycoproteins.
Comparison of the nucleic acid sequences for HIV‑1 and HIV‑2 shows approximately 60%
homology in the conserved genes, such as gag and pol , and 30%–40% homology in less conserved regions. HIV‑1 has been subdivided into group M and group O. The routes of transmission of HIV‑1 and HIV‑2 are the same. However, the transmission and the viral replication rate are much lower in HIV‑2 infections. Clinical studies have shown that in
HIV‑2 infections there is a slower disease progression than in HIV‑1 infections. In HIV‑2
infections, there is a slower rate in the decline of CD4 T‑cells and reduced viremia. Individuals infected with HIV‑2 generally have a better clinical outcome. The Atellica IM CHIV assay uses yeast-recombinant-derived antigens corresponding to the viral envelope proteins. Recombinant antigens include an HIV‑1 envelope protein and an HIV‑2 envelope protein. A synthetic peptide is added for the detection of antibodies to HIV‑1 group O. The assay uses 3 monoclonal antibodies specific to HIV p24 antigen to capture and detect HIV p24 antigen in a sample.
Performing Laboratory
Shady Grove Medical Center, White Oak Medical Center
