Washington Blade - November 26, 2004
Ryan Lee

"Of the people who tested, about 32 percent never came back to get their test results, so the effectiveness of testing at public health sites was impaired," said Bernard Branson, associate director for laboratory diagnostics at the Centers for Disease Control & Prevention.

That's because using the conventional blood test for HIV - known as enzyme immunoassay, or EIA, tests - required clinics to draw blood from a patient's vein, send the sample to a laboratory to detect antibodies to HIV and wait from a few days to two weeks for the results to return.

But in November 2002, the U.S. Food & Drug Administration approved OraQuick - a rapid test that HIV activists and health researchers hope will help revolutionize when and how people are tested for the disease that causes AIDS.

Manufactured by OraSure Technologies, OraQuick requires a drop of blood from a patient's finger to be mixed with a developing solution, and test results are usually available within 20 minutes.

"The rapid test is wonderful because you're able to give a person their results and counseling essentially immediately after you've given them the test," said Stephen Kagan, a doctor at AbsoluteCare, an HIV clinic in Atlanta. "It also enables you to screen a lot of people at the same time.

About 95 percent of the clients who get tested at the Gay Men's Health Crisis in New York choose the OraQuick test, said Drew De Los Reyes, associate director of the David Geffen Center at GMHC.

"For many people, the wait alone was enough of a barrier to keep them from going in and getting tested," De Los Reyes said. "[Now] they all say what a relief it is for them not to have to wait."

Tests that deliver results more quickly than traditional blood tests may help to trim the estimated 180,000 to 280,000 Americans who are unaware they are HIV positive, according to the CDC.

On the eve of World AIDS Day on Dec. 1, HIV activists say it's critical that people know as early as possible if they are infected with the disease.

"It's important because the sooner a person knows their HIV status, the more effectively we can treat them," said Greg Smith, director of prevention services at AIDS Survival Project in Atlanta. "We can get them into direct medical care so they will know over the long-term what they need to do to stay healthy."

Rapid tests gain in popularity

Health experts and patients alike are hopeful that OraQuick's rapid return rate doesn't appear to compromise the accuracy of the test results.

In clinical trials conducted by OraSure, OraQuick identified 99.6 of the people who were infected with HIV, while correctly clearing 100 percent of the people who were not infected.

CDC evaluations of the test since it appeared on the domestic market continue to reveal that OraQuick is "extremely accurate," Branson said.

But as popular as OraQuick is among community-based organizations and researchers, its entry into clinics across the country was controversial, Branson said.

The FDA is responsible for categorizing all laboratory tests into one of three categories depending on the degree of difficulty implementing the test - high, moderate and waived - according to the Clinical Laboratory Improvement Amendments of 1998, or CLIA.

While high and moderate tests must be conducted by doctors or other licensed lab technicians and are subject to regular inspections, "tests waived from the requirements of CLIA are tests that the FDA finds so simple and accurate that there is little risk of an incorrect testing result," according to the FDA Web site.

In January 2003, the FDA granted OraQuick a CLIA waiver, opening the door for HIV tests to be administered by clinical workers who complete a training program.

Many in the clinical laboratory industry objected to the FDA decision to grant a waiver, "fear[ing] the agency's move signaled a crack in the regulatory dam" that would make it easier for other vital tests to receive a CLIA waiver, according to an April 2004 report in the College of American Pathologists.

"There was a lot of controversy about whether to waive tests for HIV in the first place [because] people were concerned that the quality and accuracy of HIV testing be maintained," Branson said.

But worries about HIV testing being compromised by rapid tests have not materialized in the almost two years since OraQuick became available as a CLIA-waived test, said Branson, who noted that the CDC developed guidelines for administering OraQuick and made the use of rapid tests a key component of its Advancing HIV Prevention Initiative in April 2003.

In October 2004, the pharmaceutical company Trinity Biotech received CLIA-waived status from the FDA for its finger-stick rapid HIV test, Uni-Gold Recombigen.

Uni-Gold, which was first approved by the FDA in December 2003, produces results within 10 minutes with a 100 percent success rate detecting HIV among over 9,000 participants in its clinical trials, according to Trinity Biotech.

Uni-Gold is FDA-approved to detect HIV antibodies in whole blood, serum or plasma, while OraQuick is approved to detect antibodies in whole blood samples. A new OraSure product, OraQuick Advance, recently received a CLIA waiver from the FDA, and was approved to test for antibodies using oral fluids earlier this year.

OraQuick is the rapid test most used by community-based clinics, but more providers may begin offering Uni-Gold tests as they become more familiar with the test, Branson said.

The FDA categorizes two other rapid HIV tests - MedMira Laboratories' Reveal and BioRad's Multispot - as CLIA-moderate tests, meaning they will be restricted to facilities certified for high complexity tests, Branson said.

Benefits vs. drawbacks

If either an OraQuick or Uni-Gold test indicates a person is HIV-positive, the results must be confirmed by the conventional EIA test, which is still considered the "gold standard" for HIV testing, GMHC's De Los Reyes said.

Developed in 1985, EIA tests continue to account for the majority of HIV tests conducted in the U.S., and are regularly used for insurance purposes and blood screening, said Jeffery Lennox, medical director of the Grady Infectious Disease Program at Grady Hospital in Atlanta.

If a patient tests positive on an EIA test, the results must be confirmed by a second test, known as the Western Blot test. But the results from the confirmation test are usually available before a doctor informs the patient of the initial positive EIA test, meaning patients can receive more accurate information than they might receive with a rapid test, Branson said.

"With the rapid test, people are going to be getting screening results [immediately after they take the test] and in some cases it's going to be the wrong result," Branson said.

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