Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection
Section snippets
Background
Following the identification of the etiological agent of hepatitis C (HCV) infection in 1989,1 numerous laboratory-based tests have been developed and commercialized to aid in the diagnosis of HCV infection and the screening of donated blood. These include both immunoassay-based tests for antibodies produced in response to infection,2, 3 as well as nucleic acid based tests for direct detection of virus.4 However, despite significant evolution in the performance of these technologies, there
Objectives
We report here the development of a rapid, POC test for the detection of antibodies to hepatitis C virus (HCV) using the OraQuick® rapid test platform, which does not require phlebotomy and can be used with any 1 of 5 different specimen types, including whole blood from finger stick and oral fluid. This test provides a result in 20 minutes and requires no instrumentation. We have evaluated the performance of this test compared to FDA-approved laboratory-based assays currently used for HCV
Test device
The OraQuick® HCV assay utilizes an indirect immunoassay method in a lateral flow device to detect antibodies to HCV in blood or oral fluid. In this device, antigens from the core, NS3 and NS4 regions of the HCV genome are immobilized on a single test line on a nitrocellulose strip and antibodies reactive with these antigens are visualized by colloidal gold labeled with protein-A. Oral fluid samples are collected directly on a collection pad protruding from the device, before placing the device
Results
Of the 19 seroconversion series tested, HCV antibody was detected at the same time by both OraQuick® and EIA in 9 cases and earlier by OraQuick® HCV in 10 (Table 1). In no cases did EIA detect antibody before OraQuick®. Mean time to detection of seroconversion (relative to first available specimen in each series) was 61.3 days in the case of EIA and 56.4 days in the case of OraQuick® HCV. Overall, the OraQuick® HCV test detected antibody 4.9 days before EIA (95% CIs: 1.4–8.3).
Sensitivity in
Discussion
A simple, non-instrumented rapid point-of-care test for HCV may be a useful tool to address under-diagnosis of HCV infection by increasing testing opportunities outside of traditional laboratory settings, such as clinics, community outreach centers and physician offices. This approach has been shown to be beneficial in the identification of previously undiagnosed HIV infection.15 However, one of the obstacles to more widespread adoption of rapid testing for infectious diseases has been concerns
Conflict of interest
Financial relationship with OraSure Technologies, Inc.
Acknowledgements
Funding: None.
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