Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection

https://doi.org/10.1016/j.jcv.2010.02.018Get rights and content

Abstract

Background

Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings.

Objectives

We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods.

Study design

HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels.

Results

Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types.

Conclusions

The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV 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.

References (22)

  • WHO

    Weekly Epidemiology Record

    (1999)
  • Cited by (71)

    • Clinical evaluation of a hepatitis C antibody rapid immunoassay on self-collected oral fluid specimens

      2019, Diagnostic Microbiology and Infectious Disease
      Citation Excerpt :

      In this study, we evaluated the performance of the OraQuick ® HCV Rapid Antibody test when used by patients for self-testing of self-collected oral fluid specimens. To our knowledge, this is the first study in which participants collected and interpreted their test results using the OraQuick test (Ibrahim et al., 2015; Lee et al., 2010; Smith et al., 2011). The test kit showed very good performance when used by patients, but there was a small not statistically significant difference in the clinical performance of the test when interpreted by the patients compared to trained staff.

    • New virological tools for screening, diagnosis and monitoring of hepatitis B and C in resource-limited settings

      2018, Journal of Hepatology
      Citation Excerpt :

      These findings were confirmed in other meta-analyses (Table 6).38,39 However, the sensitivities and specificities of the different tests available vary widely according to the nature of the RDT, the matrix used, the matrix volume and, importantly, the population tested, as shown in recent studies performed in populations with high and low risks of infection.25,40–42 These results justify careful assessment of the clinical performance of HCV RDTs prior to recommending their broad use for HCV screening in various populations.21,25

    View all citing articles on Scopus
    View full text