OraSure begins shipping rapid HIV test to hospitals

CLIA waiver could come in several months

After years of anticipation, the first of a new generation of rapid HIV tests is being shipped to hospitals and laboratories across the country. At the same time, health officials tell AIDS Alert that the OraQuick Rapid HIV-1 Anti-body Test soon could receive an Food and Drug Administration (FDA) waiver that would allow the test to be used in outreach settings as well.

"The estimates we are hearing are maybe a couple months," says Robert Janssen, MD, acting director of the Division of HIV Prevention for the Centers for Disease Control and Prevention (CDC). "It depends on the criteria the FDA comes up with that the manufactures will have to meet in terms of what studies they have to do."

In November, the FDA approved OraQuick for use by trained personnel as a point-of-care test for diagnosing HIV infection. This simple, 20-minute test, which uses fingerstick whole blood, was categorized as one of moderate complexity under the Clinical Laboratory Improvement Amendment (CLIA).1

Tests designated as moderately complex must be performed only by skilled technicians and in a laboratory setting. Without a waiver, the test could not be used where it is needed most — in outreach settings, such as streets and bars, where the promise of instant results can allow those at highest risk to know their HIV status.

William Bruckner, OraSure Technologies spokes-man, confirmed that the company had submitted a draft protocol to the FDA proposing what studies are needed to get the waiver. "The FDA has responded and told us how we need to modify the protocol." Once the criteria are finalized, the study could be completed "in a matter of months," he says. "I can’t say how fast the FDA will respond but our work is going to be done very quickly."

The study would compare test results in trained versus untrained users, he added.

On June 17, 2002, OraSure announced it had entered into an agreement with Abbott Laboratories for the co-exclusive distribution of the OraQuick test in the United States.

In January, Abbott announced that the first batches of OraQuick were sent to hospitals and physicians’ office laboratories around the country. The only other rapid test on the market, SUDS (Murex Single Use Diagnostic System), has not been widely used. It can take up to an hour to receive results and is not as accurate as OraQuick, experts say.

"We think OraQuick offers a lot of advantages. It is easier to do. It can be done on a fingerstick blood sample. And the results can be available in about 20 minutes," said Harold Jaffee, MD, director of the CDC’s National Center for HIV, STD (sexually transmitted disease), and TB Prevention.

The test was developed as a simple diagnostic tool, similar to a pregnancy test that could be used by outreach social workers targeting hard-to-reach populations. However, its moderately complexity labeling means that OraQuick must be performed in certified clinics and settings where trained technicians can administer and read the test. Dozens of medical and political organizations have urged the FDA to approve the test under a "waived" status under CLIA, enabling its use in the field, counseling centers, family doctors offices and public health clinics.

"Based on our own experiences with the test, we think that some training — not very much — and some quality assurance are needed," Jaffee says, adding that the CDC is working on developing training and quality assurance programs.

However, critics of a waiver note that waived tests are plagued by user errors. A presentation to the CDC from federal health officials showed that half of public health labs operating under waivered certification had some procedural errors. Indeed, quality assurance is a major concern for implementing rapid testing in outreach settings. While OraQuick is considered by many to be no more complex than a pregnancy test, the consequences of errors are greater, experts note.

Another concern is that counseling will be inadequately addressed when testing is performed in nontraditional settings, such as bars and sex clubs. At least one study, from the Denver Health Department, has shown that patients receiving rapid HIV test results were more likely to get a subsequent STD than those tested conventionally. Receiving tests results faster, however, has been shown to reduce the number of patients not receiving a diagnosis. One study found that when the time for testing in a hospital laboratory averaged 107 minutes, 55% of patients left without their results. When testing was done in an emergency department and waiting time averaged 48 minutes, only 20% left without learning their results.2

The CDC estimates that 30,000 HIV tests performed annually in CDC-funded counseling and testing sites are positive. And yet 25% of results go undelivered because clients did not make it to a second visit to receive results. The CDC’s new strategic plan has set a goal of reducing new HIV infections by 50% as of 2005. That means 30,000 more people must become aware of their status each year. While rapid testing could help achieve that goal, some experts are concerned that HIV services are so strapped now that these new patients could not receive care. At least 14 states have no funds in their AIDS Drug Assistance Program (ADAP) budgets for new patients, and the number of states is increasing each month.

"If we get these 25% who don’t know their status, we could not provide care," explains Liza Solomon, director of AIDS administration for the Maryland Department of Health in Baltimore. "If you offer someone a diagnosis and no treatment, that is unethical."

Next year, two out of 10 patients now enrolled in the Texas ADAP will be cut off under a plan to meet an expected $34 million shortfall over the next two years.

Taking another point of view, health professionals point out that identifying the estimated 125,000 people in the United States who don’t know they are HIV-positive would create a strong political base from which to lobby for more HIV prevention and treatment funding.

The cost of the moderately complex test has not yet been set, Bruckner says, but will be comparable to current lab-based tests. He was not sure how a CLIA waiver would affect pricing of the test. Estimates have ranged from $6 to $15 per test, compared to several dollars for conventional HIV testing.

The cost of the OraQuick test will be a major factor in whether it gets adopted, public health officials say. The only other approved rapid HIV test, SUDS, costs substantially more than traditional HIV testing. Although SUDS worked well for public health clinics in New Jersey, the state has recently gone back to conventional blood testing, at least at its main clinics, in order to save money, according to state health officials.

"If this thing is too expensive, it’s really going to limit its use," says Dorothy Mann, director of the Southeastern Pennsylvania Family Planning Council in Philadelphia.

Deanna Sykes, PhD, a research scientist at the California Office of AIDS in Sacramento, has calculated personnel costs in California for rapid HIV testing under the two CLIA categories. Based on specific qualifications required and the state’s personnel classification system, hourly wages to perform rapid tests would be $9 if the test gets waived and $17 if it remains moderately complex. (Counseling times were derived from the counseling and testing database.)

She estimates that rapid tests require 15 minutes to perform.3 Risk assessment (pretest counseling) requires about 20 minutes. Disclosure sessions (post-test counseling) average 15 minutes for HIV-negative people and 45 minutes for HIV-positive.

Annually, a total of 117,667 hours would be required for counseling, and approximately 51,000 hours for rapid testing. If the counselor also performs the test, waived HIV testing would cost California $1,518,000 per year vs. $2,867,339 for a moderately complex test — a $1.35 million difference.

If a person other than the counselor performs the test, additional personnel costs would exceed $408,000 annually if rapid tests were categorized as moderately complex, assuming these people actually spent all hours performing tests, Sykes concludes. "The requirements for reading a moderately complex test is a lab technician, so we would have to hire one to stand by as we tested in various sites — that’s a $20-an-hour employee."

The CDC recommends that clinics should consider return rates for standard test results and the urgency of the need for test results (i.e., post-exposure and perinatal prophylaxis) in deciding whether to offer rapid testing.

(Editors’ note: The CDC has developed a question-and-answer fact sheet on OraQuick that is posted on its web site at: www.cdc.gov/hiv/pubs/rt-faq.htm.)


1. Centers for Disease Control and Prevention. Notice to readers: Approval of a new rapid test for HIV antibody. MMWR 2002; 51:1,051-1,052.

2. Kelen G, Shahan J, Quinn T, et al. Emergency department-based HIV screening and counseling. Ann Emerg Med 1999; 33:1,27-1,155.

3. Sykes D, Branson B, Truax S. CLIA-waived vs. moderately complex rapid HIV testing: How much will it cost? Presented at the National STD Prevention Conference. San Diego; March 2002.