Blood test to detect AIDS virus shortly after infection Architect HIV Ag/Ab gets approval in US

Architect HIV Ag/Ab blood test to detect HIV as soon as a person gets infection from the AIDS causing virus is now available for sale.

Architect HIV Ag/Ab can detect HIV infection earlier than the currently available diagnostic tests, said Abbott labs, which had developed the diagnostic test.

Architect HIV Ag/Ab has the ability to spot both the antigen and antibody for the HIV.

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 Abbott’s new Architect HIV Ag/Ab test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.

HIV is the most virulent and most infectious from one individual to others shortly after infection.

Hence it is critical to detect the virus as soon as it start infecting the body. This can perhaps several lives as the detection of HIV enables more effective control before it get multiplied into a full-blown infection which is often tough to tackle with anti-virals.

“A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate,” stated Peter Leone, M.D., medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill, in a press release from Abbott.

Current antibody-only tests miss up to 10 percent of HIV infections in some high-risk populations because they do not detect antigens, studies conducted by the Centers for Disease Control and Prevention (CDC) showed.

However, Abbott’s new Architect HIV Ag/Ab assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

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 adult and pediatric serum and plasma.

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 pregnant women.

However, an architect HIV Ag/A combo reactive result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.

The test is not intended for use in screening blood or plasma donors. However,Architect HIV Ag/Ab 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.

The performance of the new test has not been established for individuals younger than two years of age.

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn’t know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

Abbott’s Architect HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies.

is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.

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.

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, according to the CDC estimates.

Abbott has developed the first licensed test to detect HIV antibodies in the blood and has marketed more than 20 HIV tests. Abbott has developed two protease inhibitors for the treatment of HIV.

Abbott markets its products in more than 130 countries.