FDA approves test for early diagnosis of AIDS from HIV antigen
14 July 2010
The US FDA has approved an innovative new diagnostic tool from
Abbott that can detect the AIDS antigen and give a diagnosis of AIDS
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.
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 test may detect HIV days earlier than antibody-only
tests, which is important in controlling the spread of the virus.
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. So an early diagnosis can help stem the spread of
"Since individuals are most infectious to others shortly after
infection, detecting HIV earlier is critical and life saving," said
Peter Leone, M.D., medical director, North Carolina HIV/STD
Prevention and Control Branch, University of North Carolina, Chapel
"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 counselling,
which can reduce high-risk behaviours and also initiate
antiretroviral treatment for early-stage infection, if appropriate."
Studies conducted by the US 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, Abbott's new assay detects the
HIV p24 antigen, or the direct presence of HIV, allowing for
diagnosis of early infections days before antibodies emerge.
"Abbott has long been a pioneer in HIV testing — from the world's
first test to detect HIV antibodies in 1985 — to second and third
generation immunoassay and molecular tests, and now the development
of the country's first antigen and antibody combination test," said
Brian Blaser, senior vice president, Diagnostics, Abbott. "Abbott is
committed to fighting HIV and to bringing novel tests to physicians
in order to help patients get the care they need as soon as
This new test will run on Abbott's Architect family of diagnostic
testing instruments. It 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.