234930 Rapid hepatitis C screening using an oral swab: Public health implications for community-based organizations serving high-risk populations

Tuesday, November 1, 2011

Ann Drobnik, MPH , Division of Disease Control, New York City Department of Health and Mental Hygiene, Long Island City, NY
Caroline Judd, MPH , Office of Viral Hepatitis Coordination, New York City Department of Health and Mental Hygiene, New York, NY
David Banach, MD, MPH , Department of Medicine, Division of Infectious Diseases, Mount Sinai School of Medicine, New York, NY
Joseph Egger, PhD , Bureau of Epidemiology Services, New York City Department of Health and Mental Hygiene, New York, NY
Kevin Konty, MS , Bureau of Epidemiology Services, New York City Department of Health and Mental Hygiene, New York, NY
Eric Rude, MSW , Office of Viral Hepatitis Coordination, New York City Department of Health and Mental Hygiene, New York, NY
Objectives: The objective of the study was to evaluate the OraQuick® hepatitis C virus (HCV) rapid antibody test in community-based organizations (CBOs) serving populations at high risk for HCV infection.

Methods: Individuals who met HCV risk criteria were tested by oral swab rapid test and enzyme immunoassay (EIA) HCV-antibody test via blood draw at six CBO test sites in New York City. The OraQuick® device was evaluated by comparing results to the EIA and performing confirmatory ribonucleic acid polymerase chain reaction (PCR) testing for discordant results. The perceptions of research staff were assessed through a short survey at the end of each patient visit, and during a focus group discussion at the conclusion of the study around the potential benefits and challenges of using the rapid testing platform in the CBO setting.

Results: Overall, 97.5% of rapid test results matched those of the EIA. In six of the seven discordant pairs, the rapid test result agreed with the confirmatory PCR result. Research staff preferred using the rapid test and identified challenges with phlebotomy and locating clients to provide results that would be overcome with rapid testing. CBOs would benefit from reduced risk of needle stick injury to staff and increased testing capacity, while clients may benefit from a less invasive testing procedure and more rapid access to education, counseling, and referrals.

Conclusions: The OraQuick® rapid HCV test has accuracy comparable to the current standard EIA test. As happened when rapid HIV testing was implemented, HCV screening programs serving high-risk populations can potentially reach a larger number of individuals and expand testing into non-traditional settings using rapid testing technology. While a rapid test will not overcome the challenges facing HCV-infected clients in accessing medical care, CBOs are well positioned to provide supportive services like health insurance enrollment, support groups, education about liver care, and entry into substance use treatment.

Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice

Learning Objectives:
Compare the accuracy, ease of use and acceptability of the rapid oral swab hepatitis C test to the current standard enzyme immunoassay test Describe the potential impact of rapid hepatitis C testing on individuals at risk Describe the potential impact of rapid hepatitis C testing on community-based organizations serving high-risk populations

Keywords: Hepatitis C, Access and Services

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: The OraQuick rapid test had not been approved by the FDA at the time of the study. At the time of abstract submission, it had still not been approved for oral swab, which was the method of specimen collection used in the study, however it has been approv

Qualified on the content I am responsible for because: I am qualified to present because I was a coauthor on this paper and have worked closely with the hep-c team, as well as other infectious disease surveillance teams, to monitor screening tests, postmarketing surveillance and product safety.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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