OraSure HIV Home Test Won’t Stem Disease, Editorial Says

OraSure Technologies Inc.’s OraQuick, which allows people to screen for HIV at home, won’t help slow transmissions of the virus, a public health specialist and an infectious disease doctor said in an editorial.

Routine screening in doctors’ offices and clinics is the best way to identify people who don’t know they are infected with HIV, the virus that causes AIDS, and get them to the right care, according to the editorial published today in the Annals of Internal Medicine.

OraSure won U.S. approval for the first rapid, at-home HIV screening in July. The saliva test gives results within 20 to 40 minutes without a doctor or laboratory. The test won’t lower barriers to care because of cost and those likely to use it, said A. David Paltiel, a professor of public health and management sciences at Yale University in New Haven, Connecticut, and Rochelle Walensky, an associate professor of medicine at Massachusetts General Hospital in Boston.

“A $40 home HIV test is not even likely to make an appreciable dent in the number of undetected HIV infections,” they wrote in the editorial. “Rather, it will attract a predominantly affluent clientele composed of persons at low risk for HIV infection, persons with very recent high-risk exposures, and persons with known HIV infection seeking to monitor therapy or to pursue a misperception that treatment has reversed their seropositivity.”

Home testing may be used by someone who already knows their HIV status, starts a new sexual relationship and uses OraSure to reassure a partner, or who doesn’t want an in-office test because they have confidentiality concerns, they said.

Antibodies Response

The test doesn’t detect HIV, just the body’s response to the virus. Antibodies aren’t detectable until six weeks after infection and sometimes as long as three months, so a negative test result doesn’t always mean someone isn’t positive for HIV.

HIV screening in hospitals or doctors’ offices usually involves a blood test that screens for HIV antibodies and provides results in a few days.

OraQuick, which will sell for $39 a test, will be on store shelves this month, said Ron Ticho, a spokesman for Bethlehem, Pennsylvania-based Orasure. He said people who have never been tested or those who want to know their HIV status more frequently may be among those that use the at-home test.

“Our test is not intended to take the place of testing that takes place in a doctor’s office or a health care facility,” he said in an Oct. 5 telephone interview. “Our test is there as an additional option. It’s important to know your status.”

In the U.S., 1.2 million people have HIV and 20 percent are unaware they are infected, according to the U.S. Centers for Disease Control and Prevention. About 50,000 Americans become infected with HIV each year.

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