Seattle department finds OraSure HIV test to be less accurate than label claims

Sep 7 2008

A report by Public Health -- Seattle and King County in Washington state has found that testing with OraSure Technologies' OraQuick test provides less accurate results than the label claims, Bloomberg reports.

The OraQuick test is the only rapid test licensed to screen both oral fluids and blood for HIV, according to Bloomberg. Bob Wood, director of the HIV/AIDS control program at the Seattle-based department, said that in 5,460 tests, OraQuick failed to detect at least 8% of 133 people found to be HIV-positive with a comparable diagnostic. This compared with the 0.7% rate given on the test's label.

Elliot Cowan, chief of FDA's Center for Biologics Evaluation and Research Office of Blood Research and Review, said the agency has asked OraSure to investigate the issue. "We're keeping an ear to the phone and making sure they're doing what they're supposed to do," Cowan said, adding, "The ultimate goal is that the package insert appropriately represents the performance of the test." According to Bloomberg, CDC, which recommends testing with blood over oral fluids, also has contacted Seattle officials. Nonetheless, the agency sent a letter to physicians on Aug. 20, voicing support for oral fluid HIV testing and stating that the test has performed well "overall" and is important for increasing the number of people tested for HIV. Richard Wolitski, acting director of CDC's Division of HIV/AIDS Prevention, said, "At this time, based on all the available data, we're not changing our recommendations regarding oral fluid rapid testing."

OraSure Chief Science Officer Stephen Lee said the company tracks the performance of its test and routinely investigates complaints. Lee also said OraSure keeps FDA informed of all the product information it gathers. "All the data that we've accumulated indicates the product continues to perform according to its FDA-approved claims," Lee said.

Wood said that the department has sent its data to physicians and clinics in the area along with a recommendation to test blood rather than oral fluids when possible. "Our recommendation is that people shouldn't use rapid oral tests if they can avoid it, but there are some situations where it can't be avoided and it's better than nothing," Wood said.

According to Wood, Seattle in 2003 began back-up testing of samples screened with OraQuick. A laboratory test, called EIA, showed that OraQuick missed 10 out of 133 patients with HIV antibodies in their blood. Lee said that studies have shown rapid tests to be less sensitive than lab antibody tests, adding that other rapid tests have produced similar results. Seattle officials also tested the samples with a more accurate test that looks for HIV's genetic material. The test can detect more HIV cases because the virus appears in blood before antibodies, according to Bloomberg. When compared with the RNA test, OraQuick missed 17% of cases, according to Wood, who added that the results might be published in a journal in the future (Lauerman, Bloomberg, 9/3).