Related Experiment Video
Updated: May 30, 2026
Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques
Published on: March 13, 2015
Evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus
Bryce D Smith1, Jan Drobeniuc, Amy Jewett
1Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. bsmith6@cdc.gov
Insights
Rapid hepatitis C virus (HCV) antibody tests offer sensitive and specific results for high-risk individuals, aiding in quicker identification of chronic HCV infection among those unaware of their status.
Area of Science:
- Infectious Diseases
- Diagnostic Medicine
- Public Health
Background:
- An estimated 3.2 million Americans have chronic hepatitis C virus (HCV) infection.
- A significant percentage (50%-70%) of individuals with HCV are unaware of their infection status.
- Timely identification of HCV is crucial for effective treatment and management.
Purpose of the Study:
- To evaluate and compare the performance of rapid anti-HCV screening assays from three manufacturers.
- To assess the sensitivity and specificity of these rapid tests against established methods.
- To determine the utility of rapid tests in identifying HCV infection expeditiously.
Main Methods:
- Three rapid anti-HCV antibody assays (Chembio, OraSure, MedMira) were evaluated by the CDC.
- Performance was assessed using 1100 specimens from individuals reporting injection drug use (1997-1999).
- Sensitivity and specificity were determined using two reference approaches, including the CDC HCV testing algorithm.
Main Results:
- Rapid assay sensitivities ranged from 86.8% to 99.3% across manufacturers and methods.
- All three assays demonstrated high specificity (≥99.5%) with no significant differences.
- False positive results for Chembio and MedMira assays were associated with human immunodeficiency virus (HIV) positivity.
Conclusions:
- Rapid anti-HCV tests are capable of delivering sensitive and specific results.
- These rapid diagnostic tools can effectively identify high-risk patients with HCV infection.
- The use of rapid tests can expedite the identification process for chronic HCV.
Background:
The Centers for Disease Control and Prevention (CDC) estimates that 3.2 million Americans are living with chronic hepatitis C virus (HCV) infection and 50%-70% are unaware of their status. Although therapies are available that can suppress or eliminate infection, identifying persons infected with HCV is challenging. Rapid tests could help identify many of these persons more expeditiously.
Methods:
Three manufacturers, Chembio, OraSure, and MedMira, submitted HCV antibody (anti-HCV) rapid screening assays to the CDC for evaluation and comparison with established anti-HCV screening assays. The panel consisted of 1100 specimens drawn during 1997-1999 from persons reporting injection drug use. Sensitivity and specificity were assessed using 2 reference approaches, one based on the reactivity of samples in an anti-HCV screening assay and the other based on CDC HCV testing algorithm.
Results:
The sensitivities of the Chembio, MedMira, and OraSure assays across the 2 approaches were 96.2%-98.0%, 86.8%-88.3%, and 97.8%-99.3%, respectively. The 3 assays had specificity of 99.5% or higher with no differences between assays. False rapid assay results were associated with human immunodeficiency virus positivity for both approaches for Chembio and MedMira.
Conclusions:
Rapid anti-HCV tests can provide sensitive and specific anti-HCV results for high-risk patients.
