231700 Results from the field evaluation of pre-market rapid hepatitis C virus (HCV) antibody tests in four national HIV Behavioral Surveillance (NHBS) study sites

Tuesday, November 9, 2010 : 9:35 AM - 9:50 AM

Bryce Smith, PhD , Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA
Eyasu Teshale, MD , Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta
Elizabeth DiNenno, PhD , Centers for Disease Control and Prevention, Atlanta, GA
Amy Jewett , Division of Viral Hepatitis, Centers for Disease Control, Atlanta, GA
Alan Neaigus, PhD , HIV Epidemiology Program, New York City Department of Health and Mental Hygiene, New York, NY
Samuel Jenness, MPH , HIV Epidemiology Program, New York City Department of Health and Mental Hygiene, New York, NY
Sharon K. Melville, MD, MPH , TB/HIV/STD Epidemiology and Surveillance Branch, Texas Department of State Health Services, Austin, TX
Richard Burt , Viral Hepatitis, Seattle/King County Public Health, Seattle, WA
Hanne Thiede, DVM, MPH , HIV/AIDS Epidemiology Program, Public Health- Seattle and King County, Seattle, WA
Alia Al-Tayyib, PhD, MSPH , STD/HIV Prevention and Control, Denver Public Health, Denver, CO
Praveen R. Pannala, MD, MPH , TB/HIV/STD Epidemiology and Surveillance Branch, Texas Department of State Health Services, Austin, TX
Isa Williams Miles, ScD, MS , Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Alexandra Oster, MD , Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Amanda Smith, MPH , Division of HIV/AIDS Prevention, CDC, Atlanta, GA
Teresa Finlayson, PhD , Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Kristina Bowles , Division of HIV/AIDS Prevention, CDC, Atlanta, GA
Persons who inject drugs (PWIDs) have limited access to health care services yet are at very high risk for blood borne infections such as HCV and HIV. CDC estimates that injection drug use (IDU) accounted for 48% of acute hepatitis C cases in the United States in 2007 (MMWR, 2009), and previous studies have found prevalence of HCV infection up to 70-80% among persons who inject drugs (PWIDs). There are currently no rapid HCV tests available on the US market, but several are in various stages of development, testing, and clinical trials and one is currently under review at FDA.

To evaluate the performance of these rapid tests in field settings, CDC collaborated with four 2009 National HIV Behavioral Surveillance System (NHBS) sites (Dallas, Denver, Seattle, New York City) that conducted HCV testing among persons who injected drugs at least once in the previous 12 months. The four sites integrated both rapid and standard HCV tests (Enzyme Immunoassay and Recombinant Immunoblot Assay: RIBA) into their existing HIV testing protocol. Standard HCV test results provided a validated reference to which the rapid test results were compared. Three diagnostic manufacturers submitted five different test kits for oral fluid, finger stick blood, or both.

There was considerable variation in performance characteristics across sites and across rapid tests with substantial ranges in sensitivity (78.5%-96.2%), specificity (86.8%-100%), positive predictive value (93.8%-100%) and negative predictive value (33.6%-89.9%). Detailed site-level and test-level performance characteristics of these tests and their utility in this and other populations will be discussed.

Learning Areas:
Epidemiology
Public health or related research

Learning Objectives:
Compare pre-market rapid hepatitis C tests in terms of performance characteristics of sensitivity and specificity.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to present because I serve as the Team Lead for the Hepatitis C Prevention Research and Evaluation Team and in that capacity I oversee programs addressing hepatitis C screening strategies, evaluating HCV rapid test technologies, and HCV modeling studies including cost effectiveness and mortality/morbidity forecasting.
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.

Back to: 4024.0: Current issues in the epidemiology of hepatitis C virus (HCV) infection in the United States