The Autobio HIV assay is designed for the qualitative determination of the concentration of antibodies to the human immunodeficiency virus (anti-HIV) (1+2) in human serum or human plasma.
HIV-1 is one of the causes of AIDS (Acquired Immunodeficiency Syndrome). AIDS is the end stage of a drawn out process in which the immune system of an infected person and its ability to control infections or malignant proliferative disorders are progressively destroyed[1]. HIV is mainly transmitted through unprotected sexual intercourse or from mother to child. Most frequently, HIV infection is diagnosed by tests that assess whether an individual’s immune system has produced an HIV-specific immune response (antibodies to HIV).
In the USA the standard laboratory test algorithm (set of different tests) may take 48 hours to one week before results may be made available. This algorithm consists of screening with an enzyme immunoassay (EIA) followed by confirmation by Western Blot (WB) or immuno-fluorescent (IFA) methods.
During the last 20 years, HIV infection and severe HIV-related diseases (e.g., AIDS) have become a leading cause of illness and death in the United States. Approximately 800,000-900,000 persons in the United States are infected with HIV and approximately 275,000 of these persons might not know they are infected.
Approximately 25 million persons each year in the United States are tested for HIV. Publicly funded counseling and testing programs conduct approximately 2.5 million of these tests each year. In 1995, 25% of these individuals tested HIV positive and 33% of persons tested HIV negative at publicly funded clinics did not return for their test results. Rapid tests to detect HIV antibody can be performed within 20 minutes, enabling healthcare providers to supply definitive negative and preliminary positive results to patients at the time of testing, potentially increasing the overall effectiveness of counseling and testing programs. In comparison, results from enzyme immunoassays (EIAs) currently used for HIV screening often are not available until after 1-2 weeks. Using rapid tests, during 1995, a total of 697,495 more persons would have learned their HIV status[3].
Many advances have been made in HIV/AIDS prevention and treatment, including the development of effective antiretroviral therapies that have reduced HIV-related illness and death. Early knowledge of HIV infection is now recognized as a critical component in controlling the spread of HIV infection[2]. Rapid HIV testing allows clients to receive results the same day in a single visit, which is useful in urgent medical circumstances and settings where clients tend not to return for HIV test results (e.g., some STD clinics). Advances in these areas have resulted in revised recommendations for HIV screening of pregnant women treating opportunistic infections and other sexually transmitted and blood-borne diseases and managing occupational and non-occupational exposures and prophylaxis.
