Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites.

SUMMARY: Performance characteristics of rapid assays for hepatitis C virus antibody were evaluated in 4 National HIV Behavioral Surveillance System injection drug use sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira and OraSure tests were 94.0%, 78.9%, and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. BACKGROUND: The Centers for Disease Control and Prevention (CDC) estimates that 4.1 million Americans have been infected with hepatitis C virus (HCV) and 75%-80% of them are living with chronic HCV infection, many unaware of their infection. Persons who inject drugs (PWID) account for 57.5% of all persons with HCV antibody (anti-HCV) in the United States. Currently no point-of-care tests for HCV infection are approved for use in the United States. METHODS: Surveys and testing for human immunodeficiency virus (HIV) and anti-HCV were conducted among persons who reported injection drug use in the past 12 months as part of the National HIV Behavioral Surveillance System in 2009. The sensitivity and specificity of point-of-care tests (finger-stick and 2 oral fluid rapid assays) from 3 manufacturers (Chembio, MedMira, and OraSure) were evaluated in field settings in 4 US cities. RESULTS: Sensitivity (78.9%-97.4%) and specificity (80.0%-100.0%) were variable across assays and sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira, and OraSure tests were 94.0%, 78.9% and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. In multivariate analysis, false-negative anti-HCV results were associated with HIV positivity for the Chembio oral assay (adjusted odds ratio, 8.4-9.1; P < .01) in 1 site (New York City). CONCLUSIONS: Sensitive rapid anti-HCV assays are appropriate and feasible for high-prevalence, high-risk populations such as PWID, who can be reached through social service settings such as syringe exchange programs and methadone maintenance treatment programs.

Utility of the Beck Depression Inventory to screen for and track depression in injection drug users seeking hepatitis C treatment.

OBJECTIVE: Treating acute hepatitis C (HCV) in injection drug users (IDUs) is complicated by a high prevalence of psychiatric comorbidities that may lead to increased risk for depressive complications of interferon treatment. Effective screening strategies are needed to help non-psychiatric clinicians identify depressive disorders. METHODS: Thirty IDUs with acute HCV completed the Beck Depression Inventory (BDI), underwent a psychiatric examination, and were randomized to 24 weeks of pegylated interferon treatment (IFA) or observation (OBS). Sensitivity, specificity, positive (PPV) and negative predictive values (NPV) of the BDI for diagnosing depression (with a cutoff >10) were calculated. The psychiatrist's diagnosis was used as the gold standard. Depression severity was assessed over time with the BDI. RESULTS: Forty-seven percent of individuals met criteria for a depressive disorder. Sensitivity (91%) and NPV (92%) were high for the BDI; specificity (58%) and PPV (56%) were low. BDI worsened in 2 patients completing the study (one IFA, one OBS); two IFA patients were discontinued for possible depression-related complications. At baseline, subject-rated fatigue was associated with alanine aminotransferase level. CONCLUSION: The BDI is an adequate tool for ruling out depressive disorders in active IDUs with acute HCV, but specificity is low. Psychiatric consultation is recommended for all active IDUs being considered for acute HCV treatment.