American Association for Clinical Chemistry
Better health through laboratory medicine
October 2007 Clinical Laboratory News: The Challenges of Universal HIV Screening

 
October 2007: Volume 33, Number 10

The Challenges of Universal HIV Screening
Why Cost, Logistics, and Some State Laws Present Hurdles to CDC Recommendations

By Deborah Levenson 

Most HIV screening now occurs in traditional healthcare settings including hospitals, with 44% of adults nationwide reporting that they have had at least one HIV test, according to the Centers for Disease Control and Prevention (CDC). The agency’s statistics show, however, that these screenings are often performed too late. About 40% of new HIV diagnoses come within a year of the infection’s progression to AIDS, presumably about 10 years after they were first infected. In order to make more early HIV diagnoses, CDC has issued revised screening guidelines suggesting a radical change from longstanding policies aimed at testing those patients at high risk for contracting HIV. In these September 2006 guidelines, CDC calls upon healthcare providers in all settings to screen all patients ages 13–64, with provisions allowing patients to opt out, and recommends that those at high risk be screened at least once a year. To establish this new screening strategy, the guidelines suggest rapid HIV tests as an option in episodic care settings, and that it’s acceptable to forgo pre-test counseling and separate, written informed consent in many cases.

Now, a year after the release of CDC’s recommendations, what really has healthcare institutions stymied is the lack of funds. Laboratorians and HIV testing experts laud the agency’s goals, but maintain that universal screening of emergency department or admitted patients is impossible to do without a large government or foundation grant. “Some see the CDC recommendations as another thing the government wants us to do without providing money,” remarked Michael Lyons, MD, Assistant Professor of Emergency Medicine at University of Cincinnati in Ohio. At the same time, other federal government HIV screening recommendations are not consistent with the 2005 United States Preventive Services Task Force (USPSTF) recommendations. That group examined universal screening in 2005 and again in 2006, but found insufficient evidence “to recommend for or against” universal screening.

Meanwhile, the CDC recommendations appear to be gaining momentum, at least among hospital emergency departments. Large insurers are also looking at covering HIV screenings suggested by CDC, with at least one, Aetna, reportedly opting to do so. “I’m optimistic that the energy and interest generated by the guidelines will eventually translate into a real change in practice,” Lyons predicted.

Examining the Evidence Differently

The two different federal stances on universal screening arise from CDC’s and USPSTF’s use of different standards of evidence, explained Bernard Branson, MD, Associate Director for Laboratory Diagnostics in CDC’s Division of HIV/AIDS Prevention. “USPSTF likes to see randomized, controlled trials prior to making recommendations, while CDC has to use the best available evidence. CDC saw accumulating evidence from its demonstration projects that indicated lots of missed opportunities for screening and substantial behavioral changes accompanying knowledge of HIV status,” he explained.

The CDC guidelines emphasize the value of rapid HIV tests in speedily informing patients of their status and reducing the resources needed to locate those who are infected, especially in episodic care settings like emergency departments, where CDC encourages hospitals to begin universal screening. Rapid test results are preliminary and must be confirmed, usually by Western blot before establishing diagnosis, the agency notes. But with the 2006 FDA approval of the APTIMA HIV-1 RNA Qualitative Assay (Gen-Probe, San Diego, Calif.), healthcare workers have an additional tool to detect viral RNA and HIV infection before antibodies develop. Of the six rapid tests currently on the market, some are simple, single-use disposable devices that use minimal reagents and can provide results within 60 minutes. (See Chart)

FDA-Approved Rapid HIV Antibody Screening Tests
Test
Price per
Device*
Storage
Temperature
Operating
Temperature
Shelf Life
of Test**
Total Time
Required to
Conduct Test***
Window Period
for Reading
Results****
OraQuick ADVANCE
Rapid HIV-1/2
Antibody Test
$17.50

2–27°C (tests)

2–8°C (controls)

15–37°C
6 months
<5 min.
(<10 min.
for plasma)
+ 20 min. wait time
20–24 minutes
Uni-Gold
Recombigen HIV
$15.75

2–27°C (tests)

2–8°C (controls)

15–27°C
12 months
<5 min.
+ 10 min. wait time
10–15
minutes
Reveal G-3 Rapid
HIV-1 Antibody Test
$14.00

2–30°C (tests)

2–8°C (controls)

15–27°C
12 months
3–5 min.
No add. wait time
Result must
be read
immediately
Multispot HIV-1/
HIV-2 Rapid Test
$25.00
2–8°C or
20–30°C
(tests & controls)
20–30°C

12 months
(@ 2–8°C)

3 months
(@ 20–30°C)

10–15 min.
No add. wait time
Can be read
immediately
or any time
up to 24 hrs.
Clearview HIV 1/2
STAT-PAK
$25.00
8–30°C
18–30°C
24 months
<5 min.
+ 15 min. wait time
15–20
minutes
Clearview COMPLETE
HIV 1/2
$26.00
8–30°C
18–30°C
24 months
<5 min.
+ 15 min. wait time
15–20
minutes

*Actual price may vary by purchasing agreements with manufacturers.
**From date of manufacture, unless otherwise noted.
***First time listed is estimated time required to set up test. The second time is the required wait time before reading results. Times listed exclude time needed to draw/obtain sample.
****As measured from last step of testing process.

Chart modified with permission, copyright 2007 by the Health Educational Trust and the Centers for Disease Control and Prevention.
The original is at www.edhivtestguide.org
.

 

 

Others can be used only with plasma or serum and are classified as moderate complexity. Costs range from about $14 to $26 per assay, while the sensitivity for all the approved rapid tests is over 99%, and is up to 100% for both the Uni-Gold Recombigen HIV Test (Trinity Biotech, Bray Ireland) and Multispot HIV-1/HIV-2 Rapid Test (Hercules, Calif). Uni-Gold is approved for use in blood, serum, and plasma, while Multispot can be used in serum and plasma. The six assays’ specificities range from a low of 98.6% reported for Clearview COMPLETE HIV 1/2 (Inverness Medical Professional Diagnostics, Princeton, N.J.) to a high of 100% reported for Oraquick Advance Rapid HIV 1 /2Antibody Test (Orasure Technologies, Bethlehem, Pa.).

The CDC guidelines pay specific attention to pregnancy, stipulating that HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women, and be repeated in the third trimester in communities with high HIV prevalence among pregnant women. USPSTF’s 2005 recommendations also call for universal screening of pregnant women.

Quality Concerns: The Lab’s Role

Although CLIA-waived, rapid tests are easy to use and provide reliable results when used according to manufacturers’ instructions, “mistakes can occur at any point in the testing process, including storage and testing area temperature, test kit shelf-life, specimen collection, test performance and results interpretation, referring specimens for confirmatory testing, and managing confirmative results,” the CDC’s 2006 screening guidelines reiterate. In response to these concerns, CDC in August issued revised quality assurance guidelines for rapid HIV-antibody tests waived under CLIA. The document, written for both lab personnel who must oversee technical aspects of testing as well as laypeople, describes basic elements and organization of a quality assurance program for rapid HIV testing, including qualifications, training, and assessment of testing personnel and the specifics of running internal and external controls. The document also describes possible problems associated with follow-up and details requirements for temperature, external control results, and test result logs.

At George Washington University Hospital (GW) in Washington, D.C., the lab oversees the use of the OraQuick test. In a recent paper, authors from GW’s testing program recommend that other emergency departments planning to set up universal HIV testing programs enlist the lab’s aid in the quality assurance tasks described by the CDC guidelines. They also advocate that lab staff play a major role in decisions about charting and entering HIV test results into patients’ medical records because most computerized emergency department records have direct interfaces with the laboratories. (Academic Emergency Medicine 2007; 14: 658–661).

Some HIV testing experts have noted that use of a combination of rapid tests to both screen and confirm rapid results might further speed diagnosis of HIV infection. This scenario, now used in countries that lack resources, is slated for discussion at a December CDC conference aimed at developing new recommendations for HIV screening and diagnosis. Other topics on the agenda include laboratory-based confirmatory algorithms using supplemental Western blot, indirect immunofluorescence, nucleic acid amplification tests, algorithms for acute HIV infection screening, and new diagnostic technologies.

The Counseling Controversy

Among HIV service providers, CDC’s recommendation that pre-test counseling—beyond basic information given in a patient’s native language—should not be required is a hot topic. Some maintain that without pre-test counseling, it’s difficult to inform patients—especially those with low healthcare literacy—about the limitations of screening tests, while those who support CDC’s suggestion assert that the more important goal is to identify and inform as many HIV positive patients as possible, especially when the majority of hospitals lack funds to pay for counseling services.

Staff at Boston Medical Center’s (BMC) Project TRUST (Boston, Mass.) aim to screen as many inpatients as possible during daytime business hours and are strong proponents of pre-test counseling. They have been providing HIV testing services to a population that grapples with poverty, lack of education, and limited English skills since 1987 through a program funded primarily by the Massachusetts Department of Public Health. In 2001, BMC became a site for a series of CDC-funded demonstration projects testing routine and rapid testing in hospitals. With funding from grants, trained HIV counselors administer rapid tests, usually Oraquick, via fingerstick, and provide both pre- and post-test counseling, even if screening results are negative. About half of all cases identified through the program are patients considered to be at low risk, according to Jonathan Hall, MM, Director of Clinical and Program Operations for Infectious Disease at BMC. He added that many patients who tested negative didn’t know that antibodies to HIV can take several weeks to develop, so that a negative screening result may not accurately reflect their HIV status.

Because it is a large teaching hospital serving a sizable immigrant population, BMC needs the counseling services, maintained Hall and Vanessa Sasso, MSW, Manager of HIV Counseling, Testing, and Referral Services. “In large institutions, it’s hard to sustain a screening program by relying on routine-care providers,” Hall pointed out, explaining that in teaching hospitals especially, patients sometimes don’t get HIV test results because of intern and resident physician turnover. “You don’t want to add another burden on a physician or a nurse.” Serving a large immigrant population compounds the need for counseling, added Sasso. “People who are educated and intelligent often don’t understand the healthcare system, never mind an immigrant who doesn’t speak the language,” she pointed out, adding that BMC must also comply with state requirements that patients get results in their native language and that the hospital report them to the state by patient name. The reporting requirement makes immigrants uncomfortable and more likely to opt out of testing without proper explanation and support, she added.

BMC’s clinical laboratory handles after-hours testing and helps Project TRUST navigate a complex maze of regulatory requirements, according to Nancy S. Miller, MD, BMC’s Medical Director of the Clinical Microbiology Laboratory. A lab medical technologist who specializes in point-of-care testing oversees daily quality assurance and ensures that counselors comply with lab procedures, institutional policy, and other requirements from The Joint Commission, the College of American Pathologists, and the state’s Department of Health, Miller noted. In addition to designing the HIV program’s testing area to comply with state privacy recommendations, the technologist oversees technical training of the HIV counselors, documentation of their competency, and monitoring of quality assurance.

In contrast to BMC, the GW emergency department has provided counseling only to patients with positive screening tests under a policy that aims at universal screening of patients between 8 a.m. and midnight. Since universal screening was implemented to coincide with CDC release of its recommendations in September 2006, unpaid student research assistants working for academic credit have administered OraSure tests provided by the Washington, D.C. Department of Health after receiving 3 hours of training about how the test works and performing it under observation, noted Jeremy Brown, MD, Director of Clinical Research in the GW Emergency Medicine Department. Patients who test positive are informed of their status by the attending physician. Brown says the physician does provide these patients some counseling and ensures that they are seen in the hospital’s infectious disease clinic within a few days. With only 2 to 4 positive cases a week, doing so is not an overwhelmingly time-consuming task. “Testing has been working out wonderfully. If we had 10 positive cases per day, it would be a different story,” he noted. About 60% of patients offered HIV screening accept it, a rate that is consistent with national figures, Brown added.

The vast majority of patients who accept testing in the GW emergency department think highly of it, according to analysis of data from a survey of 1,500 patients tested in the program’s first 8 months. Stratified by income, zip code, and ethnicity, the data revealed that 80% of respondents thought the ER was a good place to do HIV testing, while African Americans were especially enthusiastic and reported they would recommend testing to a friend at a rate of 89%. Brown notes that other nonwhite patients and those of lower economic status generally accept screening at higher rates than their white and higher-income counterparts.

Who Pays?

While screening is working well at GW, Brown emphasized that because most hospitals are not reimbursed for screening, although New York State Medicaid reimburses some of that state’s emergency departments. An emergency department or hospital looking to implement universal screening must therefore find a way to pay for it. Even with public funding, universal screening programs can still impact an institution’s own resources. Lyons noted that his emergency room attempts universal screening but doesn’t do rapid testing because state money for this purpose has been diverted to other institutions with lower rates of result notification. So staff must fit finding patients to inform them of their HIV status into their already hectic schedules. While the University of Cincinnati Medical Center staff makes contact with about 75% of those who get screened, the work involved remains a disincentive to screening for some providers at institutions without resources for either rapid testing or result notification after standard testing, he maintained.

The CDC’s recommendation for universal screening and overall lack of funding to implement it raises important questions, Lyons observed. “Should the healthcare system take a role in public health and prevention? That’s exactly what CDC is asking for with these guidelines, but the U.S. healthcare system has been widely criticized for doing a poor job at prevention activities like screening. Even if HIV screening got more financing from private insurers, much of the at-risk population wouldn’t benefit because it’s uninsured,” Lyons pointed out.

Informed Consent May Present Legal Challenges

Beyond the financial and logistical hurdles to implementing the CDC recommendations, there are legal problems in some states. According to an article by Brown, 14 states currently require separate, written informed consent for HIV, although many are considering legislation to change it. Some states also have laws requiring verbal consent, partner notification, and like Massachusetts, name-based reporting of positive cases. (Academic Emergency Medicine 2007; 14: 658–661). “We haven’t institutionalized universal screening because CDC’s recommendations are superseded by Georgia law requiring specific written consent to the test and counseling,” noted Angela Caliendo, MD, PhD, Director of Emory Medical Labs in Atlanta and Professor of Pathology and Laboratory Medicine at Emory University School of Medicine. Still, some settings with CDC support have increased screening rates even with specific written consent. New York City Health and Hospitals Corporation reported in 2006 that it increased the number of patients screened via rapid tests over 2005 figures while using specific informed consent required by the state.

Costs and More Federal Help

Meanwhile, the cost of rapid testing is falling, while that of EIAs is rising, Branson noted. Rapid tests are more expensive than EIA assays, but healthcare providers now have fewer EIA assay options since bioMerieux (Durham, N.C.) withdrew its Vironostika assay from the U.S. market earlier this year. But Branson predicts new technologies will ease testing. He noted that the first FDA-approved random access EIA test, EHIV (Siemens, Tarrytown, N.Y.), approved for use with the ADVIA Centaur Immunoassay System, can give results in an hour.

To increase HIV screening rates, CDC and the Health Resources and Services Administration (HRSA) have made funds available for testing and counseling. CDC plans to distribute $35 million to jurisdictions with high rates of AIDS among African Americans, with the goal of testing 1.5 million and identifying 20,000 HIV-positive residents during 3-year pilot projects. In August, HRSA announced $70.6 million in grants to state and local government agencies as part of its Minority AIDS Initiative and Ryan White HIV/AIDS program, which fills gaps in care faced by those with low incomes and little or no insurance. Diagnostic companies are also providing aid. For example, last year Trinity Biotech (Dublin, Ireland) with the Prime Vendor Program, a negotiated pricing distribution program, provided the Uni-Gold Recombingen Rapid HIV test to participants, including public hospitals and other safety-net healthcare providers.

Prior to CDC’s recommendation for universal screening, between 16 and 22 million Americans got HIV tests each year. CDC aims to test many more. “Our ultimate goal is to diagnose as many as possible of the 250,000 to 300,000 people who are infected but don’t know it,” Branson said.

HIV Screening Resources

“Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Healthcare Settings"

“Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988”

“HIV Testing in Emergency Departments: A Practical Guide,” published by Health Research & Educational Trust