HIV ANTIGEN ANTIBODY COMBO

The performance of this assay has not been established for individuals younger than 2 years of age. Includes HIV-1p24 antigen, antibodies to HIV-1 and antibodies HIV-2. If positive sample will be fowarded to Quest for HIV-1 and HIV-2 antibodies differentiation and HIV-1 Qualitative RNA.

HIV

HIV1SER
HIV-1,HIV-2 Ab, HIV-1 p24 Antigen
HIV1/HIV2
4th Generation HIV
HIV Progressive

1.0 mL collected in a SST (serum seprator-gold top tube) AND 1.0 mL serum collected in a Red top (no gel) tube.

0.1 mL each tube

Tiger top (SST)
Gold top (SST)
Red top
Plasma – Lithium, Na heparin
Plasma –EDTA (Lavender)

Room temperature

Room Temperature: 7 days at 20-25°C
Refrigerated: 4 weeks at 2-8°C
Frozen: 3 months at ­20°C
The samples may be frozen and thawed up to 5 times.

Samples with out complete first and last name and date of birth.
Grossly hemolyzed.

Sun - Sat
 

Same day for non-reactive.

1. REACTIVE test results are confirmed by additional testing using a reference lab.
2. A reactive result using the Elecsys HIV combi PT assay does not distinguish HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody, and HIV-1 group O antibody.
3. The performance of this assay has not been established for individuals younger than 2 years of age. Definitive diagnosis of HIV infection in early infancy requires other assays, including HIV nucleic acid tests or viral culture.
4. If requested on an individual under 2 years of age, it can be ordered using the mnemonic “NEONATALHIV”. Automatically the following disclaimer is attached to all neonatal HIV testing: The performance of this assay has not been established for individuals younger than 2 years of age. Please treat both negative and positive results with caution. Repeat HIV testing should be done in a few weeks for definitive diagnosis by DNA test. 
5. The Elecsys HIV combi PT assay may not detect all infected individuals.
6. A negative test result does not exclude the possibility of exposure to or infection with HIV. HIV antibodies and/or p24 antigen may be undetectable in some stages of the infection and in some clinical conditions. 
7. A negative test result does not completely rule out the possibility of an infection with HIV. Serum or plasma samples from the very early (pre seroconversion) phase or the late phase of HIV infection can occasionally yield negative findings. The presence of HIV antigen or antibodies to HIV is not a diagnosis of AIDS.
8. A person who has antigen or antibodies to HIV is presumed to be infected with the virus. However, a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.

Non-reactive

Intended for the in vitro qualitative determination of HIV 1 p24 antigen and antibodies to HIV 1 (HIV 1 groups M and O) and HIV 2 in human serum and plasma. Elecsys HIV combi PT is intended to be used as an aid in the diagnosis of HIV 1 and/or HIV 2 infection, including acute or primary HIV 1 infection. The assay may also be used as an aid in the diagnosis of HIV 1/HIV 2 infection in subjects greater than 2 years of age and in pregnant women. A reactive result using the Elecsys HIV combi PT assay does not distinguish HIV 1 p24 antigen, HIV 1 antibody, HIV 2 antibody, and HIV 1 group O antibody. The human immunodeficiency virus (HIV), the causative agent of Acquired Immunodeficiency Syndrome (AIDS), belongs to the family of retroviruses. HIV can be transmitted through contaminated blood and blood products, through sexual contact or from a HIV infected mother to her child before, during and after birth. Two types of human deficiency viruses, called HIV 1 and HIV 2, have been identified to date. Various subtypes of the known human immunodeficiency viruses have been described, each of which has a different geographical distribution. HIV 1 can be divided into 3 distantly related groups: group M (for main), group N (for non M, non O) and group O (for outlier). Based on their genetic relationship, at least 9 different subtypes (A to D, F to H, J, K) have been identified within HIV 1 group M.7 Recombinant HIV 1 viruses consisting of sequences of two or even more different subtypes exist and are spreading epidemically. Antibodies to HIV proteins, indicating the presence of an HIV infection, can be found in the serum usually 6 12 weeks after infection. Due to differences in the sequence of immunodominant epitopes, especially in the envelope proteins HIV 1 group M, HIV 1 group O and HIV 2, specific antigens are necessary to avoid failure in the detection of an HIV infection by immunoassays.By detecting the HIV 1 p24 antigen in blood specimens of recently infected patients with a high viral load, HIV infection can be detected about 6 days earlier than with traditional antibody assays. Anti HIV antibodies and the HIV 1 p24 antigen can be detected simultaneously using a 4th generation HIV assay. This leads to improved sensitivity and therefore, a shorter diagnostic window as compared to anti HIV assays.