Experts say OraSure could lead to more people knowing their status but fear those who learn they have the virus won’t get counseling, care



RAPID RESULTS | James Lester, a registered nurse at Resource Center Dallas’ Nelson-Tebedo clinic, demonstrates the OraSure rapid HIV test this week. The test is already being used at Nelson-Tebedo but has not yet been approved by the FDA for home use. (David Taffet/Dallas Voice)

DAVID TAFFET  |  Staff Writer

When longtime Fort Worth activist David Mack Henderson tested positive for HIV, all sorts of things went through his head.

“If I didn’t have people around me when I got the news, I don’t know what I would have done,” he said. “That’s not news you need to learn alone.”

But that’s what’s likely to start happening soon, after in-home rapid HIV testing from OraSure was approved by an advisory panel of the FDA on May 15. Counseling, along with medical information and referrals, is commonly provided to those who test positive at an HIV/AIDS agency or in a doctor’s office.

“Some might unnecessarily commit suicide because they didn’t know they had a life to lead,” Henderson said. “There is a psychological imperative to having someone present.”

Others, like Jeff Strater of Dallas, said while he shares some of the concerns about the missing counseling component, he believes there’s value in wider availability of testing.

“It might appeal to some who wouldn’t otherwise get tested,” Strater said, adding that for someone who gets tested annually, checking at home six months later would be a good option. “But for the first-time tester, the clinic is the best place.”

Local HIV/AIDS experts also said they have mixed feelings about in-home rapid HIV testing.

The test utilizes a mouth swab and returns results in 20 minutes.

Other in-home tests for HIV that have already been approved require taking a blood sample that is sent to a lab.

“The hope would be that the rapid at-home test would help us identify some of the 1 million HIV-infected people who remain undiagnosed,” said Bret Camp, health services director at Resource Center Dallas.

Camp said in-home testing could lead to more people knowing their HIV status and, in turn, earlier intervention.

Dr. Nick Bellos, an Oak Lawn physician with a specialty in HIV care, called the in-home test a step forward that will increase accessibility. He said some people are more likely to test at home than at a clinic or a public event like a health fair.

Bellos said he’s seen three or four patients who’ve done the mail-in blood tests at home, but even with the new rapid oral version, a positive result needs to be confirmed.

“But anything that encourages people to get into the healthcare system is good,” Bellos said.

Resource Center’s Nelson-Tebedo clinic uses a rapid test made by the same company seeking approval for the in-home version.

Camp said that the accuracy rate of the rapid test at the clinic under controlled conditions is 99.8 percent.

However, the FDA report indicates an accuracy rate of only 93 percent for in-home tests. In pre-approval studies, the reasons for test failure range from not understanding or fully following the directions to mishandling the product.

Even with such a high accuracy rate at the clinic, Camp said all tests are confirmed with a blood test.

“We want to make sure there’s not another auto-immune disease such as multiple sclerosis, Lou Gehrig’s disease or lupus going on,” he said.

Camp said he’s worried about people who don’t understand the need to follow the diagnosis with medical care before the onset of symptoms.

“There could be a disconnect if they get a diagnosis and do not seek treatment,” Camp said.

He said that the main reason he hears people say they do not seek medical care is, “I don’t feel bad.”

The test only reveals HIV status. After diagnosis, testing is necessary to determine viral load and T-cell count, Camp said. Those are important numbers to determine when to begin taking medication. To remain healthy, the recommendation is to begin medication before the immune system is destroyed.

The in-home rapid test can detect the virus beginning three months after exposure. A nucleic acid amplification test will detect the HIV virus 10 days after exposure, but that won’t be available for in-home testing.

Camp said a negative result on an in-home test might give someone a false sense of security. Someone who does an at-home test too soon after exposure and then continues risky behavior is more likely to spread the disease than someone who is positive, on medication and has a negligible viral load count.

Camp said that no matter how good the literature accompanying the test, “one size does not fit all.”

Abounding Prosperity CEO Kirk Myers said he also has concerns about the in-home test, especially for his target constituency in South Dallas. He said couples who come to his agency are always tested and given results separately. Myers said he fears possible domestic violence when positive results occur from an at-home test and no counseling is available.

Another concern is people not accessing healthcare.

“Will people go underground?” he said.

Myers said that he and his staff walk many people through the process of testing to accessing healthcare when they come to his agency. He worried that some people who get a positive result at home would ignore the results until their immune systems were so compromised that the first contact with healthcare was while battling an opportunistic infection.

Myers also noted that for some, the in-home tests won’t be affordable.

“At $50 a pop, a lot of people won’t have access to it,” he said.

But Bellos said he hopes at that price, most people purchasing the test will take it seriously, read the accompanying material and seek medical care if positive.

Those looking for lower-cost alternatives or not willing or able to read the directions could continue to access reliable, lower-cost or free testing at clinics or HIV/AIDS agencies.

The FDA will decide this year whether to approve the product for sale. If so, in its report on the product to the agency, OraSure has promised to blanket media with advertising “to drive consumer awareness and testing.”

This article appeared in the Dallas Voice print edition June 22, 2012.