CLIA waiver crucial to rapid test adoption

Study finds numerous errors for waived tests

An unpublished California study has found that more than half of new HIV infections came from sites that would not be able to use the OraQuick HIV rapid test as it is currently labeled.

In 2001, the study found, 629 HIV-positive test results in the state were not delivered to patients. Nearly 400 of those results came from settings where a rapid test of moderate complexity would not be available.

The study underscores just how important it is to have a waiver from the Clinical Laboratory Improvement Amendment (CLIA) for the adoption of the Food and Drug Administration (FDA)-approved rapid HIV test OraQuick.

"My estimation is that we would be lucky to get a moderate-complexity rapid test into one-third of these sites," says Deanna Sykes, PhD, a research scientist at the California Office of AIDS in Sacramento.

The state has 450 publicly funded HIV testing sites. Counseling costs alone exceed $1.5 million a year.

The CLIA requirements for a moderately complex test would dramatically increase those costs, primarily because each site would need a phlebotomist to administer the tests and a qualified laboratory to analyze the results. If rapid tests were adopted in those sites, counseling costs could reach $7 million for counseling personnel alone, Sykes says.

California received funding from the Centers for Disease Control and Prevention (CDC) two years ago to evaluate the OraQuick testing in emergency departments. However, the research was not done because any test prior to FDA approval is considered highly complex and, therefore, would need trained personnel to conduct it.

"We would have liked to have been ahead of the game and provided the CDC with data but we couldn’t," Sykes says. If adopting the OraQuick tests, providers must address numerous issues, such as pre-testing counseling changes, patient flow, whether one or two staff can conduct the test, and what patients will do while they are waiting for 20 minutes, she says.

"Some sites have talked about not having all counselors actually performing the rapid tests but having only one or two who would specialize in it while others would do the counseling," she explains.

The total time needed for rapid testing should be about the same as traditional testing, Sykes says. The difference will be how it is spread out. Currently, the state’s counseling protocol calls for a 20-minute risk assessment at pretest and another 20 minutes at post-test counseling to discuss test results and risk reduction. With rapid testing, risk assessment and test result disclosure will be done in one session.

Perhaps the biggest increase in counseling services will be due to patients who didn’t return for test results with conventional testing now will be getting their results and will need post-test counseling, she explains. "We will be increasing test loads but also increasing services."

California is working on various testing and counseling protocols in anticipation that OraQuick will get a CLIA waiver. The big question is over training requirements. "We will change counseling protocols in a handful of sites, and if things work out well we will expand them," Sykes says.

"Either way, none of our counselors can do this without additional training. We don’t want to put someone out there in the position of delivering positive results without understanding what it means in their setting and how to do it in compliance with California law," she explains.

Some states have laws that prohibit untrained professionals from giving positive results.

"Our lawyers say we can deliver this type of preliminary positive result as long as we are clear about what we are saying," Sykes points out.