Details:

Alternative Title:
J Clin Virol
Personal Author:
Jewett, A. ; Smith, B.D. ; Garfein, R.S. ; Cuevas-Mota, J. ; Teshale, E.H. ; ... More +
Jewett, A. ; Smith, B.D. ; Garfein, R.S. ; Cuevas-Mota, J. ; Teshale, E.H. ; Weinbaum, C.M. Less -
Description:
Background

Approximately 4.1 million Americans are estimated to have been infected with hepatitis C virus (HCV), 45–85% of whom are unaware of their infection. Persons who inject drugs (PWID) account for 55.8% of all persons with HCV antibody (anti-HCV) in the U.S. PWID have limited access to healthcare and are infrequently tested for anti-HCV using conventional laboratory assays.

Objective

To evaluate performance characteristics (sensitivity and specificity) of three, pre-market rapid point-of-care tests (one oral fluid and two finger-stick assays) from two manufacturers (Chembio and MedMira) in settings providing services to young adult PWID in San Diego, CA.

Study design

Behavioral risk assessment surveys and testing for HCV were conducted among persons who reported injection drug use (IDU) within the past 6 months as part of the Study to Assess Hepatitis C Risk (STAHR) among PWID aged 18–40 years in 2009–2010. Sensitivity and specificity of the rapid anti-HCV assays were evaluated among STAHR participants, using two commonly used testing algorithms.

Results

Variability in sensitivity (76.6–97.1%) and specificity (99.0–100.0%) was found across assays. The highest sensitivity achieved for the Chembio finger-stick blood, Chembio oral fluid and MedMira finger-stick blood tests was 97.1%, 85.4% and 80.0% respectively; the highest specificity was 99.0%, 100.0% and 100.0%, respectively. In multivariate analysis false negative anti-HCV results were associated with female sex for the MedMira blood assay.

Conclusions

Sensitive anti-HCV rapid assays are appropriate and feasible for high-prevalence, high-risk populations such as young PWID.


Subjects:
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Adolescent Adult Clinical Laboratory Techniques Female Hepacivirus Hepatitis C Antibodies Humans Immunoassay Male Point-of-Care Systems Sensitivity And Specificity Substance Abuse, Intravenous Time Factors Virology Young Adult
Source:
J Clin Virol. 54(3):213-217.
Pubmed ID:
22560051
Pubmed Central ID:
PMC5484575
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Place as Subject:
United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:216bcf9d0552539c72544d69d261fadb57a4d5fee22c28daa787011076fd2455
Download URL:
https://stacks.cdc.gov/view/cdc/46441/cdc_46441_DS1.pdf
File Type:

Supporting Files

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