Reuters: FDA approves HIV test to be released by the end of the year
by Jon Lentz
The diagnostic test, developed by Abbott Laboratories Inc, detects the virus more accurately in the weeks immediately following transmission, the company said.
The sooner patients are diagnosed and placed into care, the better the chance there is to stop further spread of the virus, said Abbott’s senior director for research and development of infectious disease diagnostics.
“With this test, we can detect probably at least 90 percent of the so-called acute infections, people in those early stages, in those first few weeks before they develop those antibodies,” Abbott’s Gerald Schochetman told Reuters in an interview.
Abbott’s test would be the first U.S. test that directly identifies HIV while currently-available tests detect the antibodies that combat the virus and show up weeks later.
The test also is the first approved by the FDA for pregnant women, which could allow them to more quickly start treatment to limit transmission of the virus to their fetuses.
The test, called ARCHITECT HIV Ag/Ab Combo assay, has been available in Europe since 2004 and is commonly used in countries such as the United Kingdom and France.
Approximately 18 million people in the United States are tested each year for HIV, which can lead to acquired immune deficiency syndrome, or AIDS, according to the U.S. Centers for Disease Control and Prevention. One in five infected individuals doesn’t know they have the virus.
About 56,000 people in the United States are infected with HIV each year, and more than a million are living with HIV, the CDC has said.
Abbott’s test will cost about the same as a standard HIV blood test and should be available by the end of the year, company spokeswoman Darcy Ross said.
If this test has been available in Europe since 2004, what has the US been waiting on. Maybe our government hoping to thin the population. Why has this not been in main stream media, they seem to be so bias on everything else they report these days, guess not important enough or sensorship, who knows.