Evaluation of a new rapid test kit to detect hepatitis C virus infection

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Abstract

This study investigated the performance characteristics and diagnostic usefulness of a new rapid device test (RDT) for HCV (SD Bioline, Korea). A total of 200 specimens were used in this study and to assess cross-reactivity, five hepatitis B surface antigen (HBsAg) positive, five anti-hepatitis B surface antibody (anti-HBs) positive, five rheumatoid factor (RF) positive, and six samples from multiple myeloma patients were tested. The early detection capability of the test was assessed using seroconversion panels. Sensitivity and specificity were calculated compared with a recombinant immunoblot assay (RIBA). Sixty-six cases were positive by the RIBA, while 52 cases were positive using the new RDT. The sensitivity and specificity of the new RDT were 78.8% (95% CI: 71.2-86.8%) and 100%, respectively. The kappa value for the agreement between the new RDT and RIBA results was 0.831 (95% CI: 0.746-0.916). The early detection capability of the new RDT and a HCV EIA were similar, with the same window period. The new RDT did not cross-react with HBsAg, anti-HBs, RF and immunoglobulins. In conclusion, the SD Bioline HCV RDT has superior sensitivity and specificity than the GENEDIA® HCV Rapid LF that is used in Korea. This assay can be used for HCV screening, especially in small hospitals, without the financial burden of expensive equipment.

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Most cited references 10

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Unravelling hepatitis C virus replication from genome to function.

Brett Lindenbach, Charles Rice (2005)

Since the discovery of the hepatitis C virus over 15 years ago, scientists have raced to develop diagnostics, study the virus and find new therapies. Yet virtually every attempt to dissect this pathogen has met with roadblocks that impeded progress. Its replication was restricted to humans or experimentally infected chimpanzees, and efficient growth of the virus in cell culture failed until very recently. Nevertheless hard-fought progress has been made and the first wave of antiviral drugs is entering clinical trials.

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Comparison of a newly developed automated and quantitative hepatitis C virus (HCV) core antigen test with the HCV RNA assay for clinical usefulness in confirming anti-HCV results.

Hasan Polat, Yuksel Terzi, M Kurtoglu … (2011)

Hepatitis C virus (HCV) is a global health care problem. Diagnosis of HCV infection is mainly based on the detection of anti-HCV antibodies as a screening test with serum samples. Recombinant immunoblot assays are used as supplemental tests and for the final detection and quantification of HCV RNA in confirmatory tests. In this study, we aimed to compare the HCV core antigen test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV core antigen test may be used as an alternative confirmatory test to the HCV RNA test and to assess the diagnostic values of the total HCV core antigen test by determining the diagnostic specificity and sensitivity rates compared with the HCV RNA test. Sera from a total of 212 treatment-naive patients were analyzed for anti-HCV and HCV core antigen both with the Abbott Architect test and with the molecular HCV RNA assay consisting of a reverse transcription-PCR method as a confirmatory test. The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 96.3%, 100%, 100%, and 89.7%, respectively. The levels of HCV core antigen showed a good correlation with those from the HCV RNA quantification (r = 0.907). In conclusion, the Architect HCV antigen assay is highly specific, sensitive, reliable, easy to perform, reproducible, cost-effective, and applicable as a screening, supplemental, and preconfirmatory test for anti-HCV assays used in laboratory procedures for the diagnosis of hepatitis C virus infection.

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Evaluation of a rapid assay as an alternative to conventional enzyme immunoassays for detection of hepatitis C virus-specific antibodies.

Hubert Darius-J Daniel, Priya Abraham, Sukanya Raghuraman … (2005)

A rapid membrane flow-through immunoassay to detect antibodies to hepatitis C virus was compared with a commercial enzyme immunoassay (EIA) and microparticle enzyme immunoassay (MEIA) using 2,590 serum samples. Sensitivity and specificity of the "rapid assay" in comparison to the EIA/MEIA were 99.3 and 99.0%; the correlation coefficient being 0.91. This assay is suitable where infrastructure and laboratory expertise are limited.