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Published on September 03, 2010

Avera McKennan First in the Country to Run New HIV Test

Test Detects HIV Infection Earlier than Tests Currently in Use

SIOUX FALLS (Sept. 3, 2010) - Avera McKennan Hospital & University Health Center in Sioux Falls is the first facility in the country to run an important new HIV test which can detect the virus sooner, so that patients understand their HIV status earlier and take measures to stop the spread of the virus.

Previous HIV tests detected only antibodies - the body's reaction to the virus. Abbott's ARCHITECT HIV Ag/Ab Combo assay is a simple blood test that detects antibodies as well as HIV antigen - a protein produced by the virus immediately after infection. This first fourth-generation HIV assay was approved by the U.S. Food and Drug Administration in June.

"This is very significant, because HIV could potentially be detected several days earlier," said Dr. Aris Assimacopoulos, infectious disease specialist at Avera McKennan. "When patients know they are infected with HIV, they are much more likely to change their behavior patterns to prevent spread of the disease. Also, like most viruses, HIV is most infectious within the first eight weeks after infection. For these reasons, this test ultimately has the potential to reduce HIV infections."

"It is very exciting that Avera McKennan has been chosen to run the first ever ARCHITECT test," said Leo Serrano, Avera McKennan Laboratory director. "It speaks well of our technological updates, expertise, and accuracy." The Avera McKennan Laboratory is the first hospital lab to have gained the rigorous ISO 15189SM accreditation from the College of American Pathologists, and was named Laboratory of the Year in 2010 by Medical Laboratory Observer magazine. Lab testing accuracy is measured at 99.99993%.

"Avera McKennan was chosen to be the first lab in the nation to run Abbott's new ARCHITECT HIV Combo assay because of their exceptional commitment to quality and innovation," said David Wells, Health Systems manager for Abbott Diagnostics. "Many laboratories require a lengthy evaluation before adding new tests, but Avera McKennan's laboratory director, knowing the significance of this new assay, wanted to be one of the first to offer it, so it seemed like a good partnership."

"Avera McKennan and Abbott share a passion for excellence in serving physicians and their patients. Abbott's ARCHITECT HIV Combo assay is the first of its kind in the U.S., but the only way it will make a difference for patients is when leaders in health care like Avera McKennan choose to integrate it into their laboratory," Wells said.

More than 1 million people in the United States are infected with HIV, and one in five of those people don't even know they are infected. In fact, up to 50 percent of ongoing transmissions come from people who were recently infected.

Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss up to 10 percent of HIV infections in some high-risk populations because they do not detect antigens. However, because the new assay detects the HIV-1 p24 antigen, or the direct presence of HIV, it allows for the diagnosis of early infections days before antibodies emerge.

"While you hear less about HIV in the United States these days, the war against HIV is far from over. 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," Serrano said. "We are pleased to be the first institution in the United States to provide this test so patients and physicians can get their results sooner."

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 may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between 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 two years of age.

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.