TUCSON, Ariz. (Nov. 23, 2010) – More than 1 million people in the United States are infected with HIV, and one in five of those individuals don't know they are infected, according to the U.S. Centers for Disease Control and Prevention. To help patients understand their status sooner, a new test to help detect the infection earlier now is available at University Physicians Hospital.
"While you hear less about HIV in the United States these days, the war against HIV is far from over,” said Lauren LeBeau, MD, medical director of UPH Hospital laboratory.“More than 56,000 people are newly infected each year. The approval of HIV combination assays in the United States represents an advancement toward controlling the spread of the virus."
Approved by the U.S. Food and Drug Administration in June, Abbott's ARCHITECT HIV Ag/Ab Combo assay is a simple blood test that simultaneously can detect both HIV-1 p24 antigen and HIV-1 or HIV-2 antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. Studies have demonstrated that the new test may detect HIV infection days earlier than antibody-only tests. This test is also the first HIV test that is FDA approved to be performed on children as young as 2 years of age and on pregnant women.
“The sooner patients can find out if they are infected, the sooner they will be aware of their status and receive the appropriate counseling and treatment,” Dr. LeBeau said. “We are pleased to be one of the first institutions in the United States and the only place in Tucson to provide this test so patients and physicians can get their results sooner."
People wishing to be tested must have a physician referral. The laboratory is located on the second floor at UPH Hospital at 2800 E. Ajo Way in Tucson. More information is available by calling (520) 874-2830.
UPH is a nonprofit corporation created in 1985 as the medical practice of the physicians of The UA College of Medicine. Together, UPH, the University of Arizona, UPH Hospital and University Medical Center combine to care for patients, educate medical students, train young physicians and conduct clinical research. With more than 400 physicians and 2,000 staff members, UPH is Arizona’s largest physicians group.
About HIV: The CDC estimates there are 56,000 new cases of HIV in the United States annually, and that every nine and a half minutes, someone in the country is infected with HIV. UNAIDS estimates that 2.7 million people throughout the world are newly infected with HIV each year. Leading risk factors for HIV infection include high-risk heterosexual contact, intravenous drug use, and male-to-male sexual contact.
ARCHITECT HIV Ag/Ab Combo Assay: Intended Use and Important Safety Information
Intended Use: The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay also may be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (children as young as 2 years) and in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish among the detection of HIV p24 antigen, HIV-1 antibody or HIV-2 antibody. The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
Important Safety Information: Assay results should be interpreted in conjunction with the patient's clinical presentation, history and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. The performance of this assay has not been established for individuals younger than 2 years.
For In Vitro Diagnostic Use
CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.
For complete information, see the assay specific package insert on www.abbottdiagnostics.com.