New nationwide HIV home test services receive FDA clearance; Home Access Express to offer results in three business days.HOFFMAN ESTATES Hoffman Estates A village of northeast Illinois, a suburb of Chicago. Population: 49,700. , Ill.--(HealthWire)--July 24, 1996--Home Access Health Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market Home Access Express(TM) and Home Access(TM), the first HIV-1 testing and counseling systems to allow people nationwide to anonymously collect a blood sample, access professional pre-test and post-test counseling 24-hours a day, seven days a week, and receive test results in either three business days or one week, depending on the type of collection kit purchased. "Home Access Express(TM) and Home Access(TM) will give people the unique flexibility to learn their HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. status and speak with professional counselors whenever and wherever it is most convenient," said Allan P. Frank, MD, attending physician at Illinois Masonic Medical Center in Chicago, and medical director for Home Access. "We hope the benefit of 24-hour counseling and a short wait period for a test result will encourage more people to learn their HIV status." Consumers are now able to purchase Home Access Express(TM) by calling 1-800-HIV-TEST, and orders will be taken by the company immediately with delivery beginning on or before Aug. 1. Home Access also will distribute its services through public health and over-the-counter in pharmacies and other national retail outlets later this year. Home Access' HIV home test system is comprised of a four step process: (1) anonymous registration and pre-Test counseling, (2) sample collection, (3) laboratory processing, (4) Test result retrieval and post-Test counseling. (1) Anonymous Registration and Pre-Test Counseling __________________________________________________ After purchasing Home Access Express(TM) and Home Access(TM), people are instructed to call a toll-free number to register a Home Access code number and participate in pre-test counseling. Callers will be asked to respond to a series of questions to determine their risk of HIV infection and listen to a series of education messages that explain how HIV is transmitted and possible test result outcomes. Callers respond to these questions by pressing the appropriate number on a touch-tone phone. While instructional booklets are available as a supplement, callers who wish to talk with a professional counselor can do so at any time during the call by pressing "0". (2) Sample Collection _____________________ Individuals will provide a blood sample by pricking a finger and placing drops of blood on special filter paper. The sample is packaged in a safe return pouch and sent to Home Access' laboratory for testing and proper disposal. A pre-paid FedEx(R) (Home Access Express(TM)) or U.S. Postal Service The U.S. Postal Service (USPS) processes and delivers mail to individuals and businesses within the United States. The service seeks to improve its performance through the development of efficient mail-handling systems and operates its own planning and engineering programs. (Home Access(TM)) shipping envelope is provided. (3) Laboratory Processing _________________________ Test results will have the same level of accuracy as HIV tests HIV test Various tests have been used to detect HIV and production of antibodies thereto; some HTs shown below are no longer actively used, but are listed for completeness and context. See HIV, Immunoblot. ordered by a doctor or clinic. Home Access will screen each specimen for the presence of the antibody to the HIV-1 virus using the FDA licensed HIV-1 Enzyme Linked Immunosorbant Assay (ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. ) test kit. Specimens found to be reactive will be re-screened twice with the ELISA. Repeatedly reactive specimens will be confirmed using an FDA licensed immunofluorescent assay Immunofluorescent assay (IFA) A blood test sometimes used to confirm ELISA results instead of using the Western blotting. In an IFA test, HIV antigen is mixed with a fluorescent compound and then with a sample of the patient's blood. (IFA Immunofluorescent assay (IFA) A blood test sometimes used to confirm ELISA results instead of using the Western blotting. In an IFA test, HIV antigen is mixed with a fluorescent compound and then with a sample of the patient's blood. ) manufactured by Waldheim Pharmazuetica (Vienna, Austria). All laboratory procedures and test protocols have been reviewed by the FDA. (4) Test Result Retrieval and Post-Test Counseling __________________________________________________ When test results are available, users call the toll-free 800 number and re-enter re·en·ter also re-en·ter v. re·en·tered, re·en·ter·ing, re·en·ters v.tr. 1. To enter or come in to again. 2. To record again on a list or ledger. v.intr. their Home Access code number. Before results are delivered, callers will hear an important reminder that an HIV-1 antibody test is unable to detect recent infection during what is known as the "window period," and that individuals who recently engaged in high-risk activities should re-test and refrain from behavior that might lead to HIV infection. Most people who test negative for the HIV-1 antibody test will be informed by Home Access' automated system with the option of speaking with a counselor at any time during their post-test counseling call. For quality assurance, some people who test negative will be informed by a Home Access counselor. Individuals who test positive will hear their result from a professional counselor who will then explain the test result, provide emotional support, offer assistance with partner notification partner notification Public health Any formal and systematic means of informing the sexual partner(s) of a person with an STD, that the person being tested is infected with an organism–eg, HIV, N gonorrhoeae, T pallidum , and give medical/social referrals for long-term counseling and medical treatment. Counselors are available 24-hours a day, seven days a week. The retail prices for Home Access Express(TM) and Home Access(TM) will be $49.95 and $39.95, respectively, with a portion of proceeds donated to HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome service organizations. The service will be offered in both English and Spanish with bilingual written instructions and 24-hour availability of Spanish-speaking counselors. Created in 1992, Home Access is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. dedicated to breaking the barriers in healthcare by bringing people and technology together through telemedicine. Home Access' HIV at-home test service combines in-home specimen collection with clinical laboratory testing and medically-directed counseling and referrals. CONTACT: Home Access Health Corp. Kevin Johnson Kevin Maurice Johnson (born March 4, 1966 in Sacramento, California) is a retired American basketball point guard who played for the NBA's Cleveland Cavaliers and the Phoenix Suns. , 847/781-2504 kj@homeaccess.com or Edelman Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most Wendy Emanuel, 312/240-2705 wemanuel@edelman.com |
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