Evaluation of clinical usefulness of second‐generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0

Yokosuka, Osamu; Kawai, Sadaaki; Suzuki, Yôichi; Fukai, Kenichi; Imazeki, Fumio; Tada, Motohisa; Mikata, Rintarou; Hata, Akira; Saisho, Hiromitsu

doi:10.1111/j.1478-3231.2005.01185.x

Cited by 10 publications

(14 citation statements)

References 33 publications

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“…Both assays have shown good correlations to HCVcoreAg in previous studies 11,12 and an excellent correlation among each other of 0.96. 13 Thus we consider the values for HCV RNA independent from the HCV RNA assay used.…”

Section: Quantification Of Hcv Rnamentioning

confidence: 72%

HCV core antigen testing in HIV- and HBV-coinfected patients, and in HCV-infected patients on hemodialysis

Mederacke

Potthoff

Meier

et al. 2012

Journal of Clinical Virology

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Section: Quantification Of Hcv Rnamentioning

confidence: 72%

HCV core antigen testing in HIV- and HBV-coinfected patients, and in HCV-infected patients on hemodialysis

Mederacke

Potthoff

Meier

et al. 2012

Journal of Clinical Virology

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“…In addition, nucleic acid amplifications are labor-intensive and time-consuming methods and have the risk of laboratory contamination; for these reasons, amplification methods are not suitable for widespread use in most laboratories, especially in developing countries (1,4,11,23,27). Therefore, the HCV Ag assay is needed as a supplemental or preconfirmatory test to preconfirm anti-HCV results and distinguish false-positive results from the accurate ones because it is easy to perform and reliable, has high specificity and sensitivity rates, is cost-effective, is able to shorten the duration of the time to diagnosis of infection in patients during the window period, and has a lower risk of laboratory contamination than assays based on nucleic acid amplification technology (31,28). During the past decade, several HCV Ag tests have been developed as potential alternatives to the HCV RNA assay (3).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2011

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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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“…In the previous report, which utilized the same Ag assay and a different RNA assay (Roche Cobas Amplicor HCV monitor 2.0), the correlation coefficient was 0.74 (n ϭ 197) (11). Another HCV Ag assay also showed a good correlation (n ϭ 213; r ϭ 0.848) with the Amplicor HCV monitor 2.0 assay (18).…”

mentioning

confidence: 95%

“…Furthermore, the HCV Ag assay could also be useful in monitoring immunocompromised patients and those undergoing hemodialysis (10). However, most of the past studies detecting HCV Ag utilized enzyme-linked immunosorbent assays (ELISAs) or enzyme immunoassays (EIAs) (4,7,14,18), which may need considerable time and skills. Recently, a fully automated chemiluminescent immunoassay (CLIA) with higher sensitivity and throughput was developed to overcome shortcomings of the conventional core Ag assays (11).…”

mentioning

confidence: 99%

New Automated Hepatitis C Virus (HCV) Core Antigen Assay as an Alternative to Real-Time PCR for HCV RNA Quantification

Park¹,

Lee²,

Kim

et al. 2010

J Clin Microbiol

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An automated hepatitis C virus (HCV) antigen (Ag) assay was evaluated with clinical samples. Determination of HCV Ag and RNA levels in 282 subjects using Abbott HCV Ag and Roche Cobas TaqMan assays revealed that these two tests were highly correlated (r ‫؍‬ 0.9464). Thus, the HCV Ag assay could be an alternative test to quantitative reverse transcription-PCR.Hepatitis C virus (HCV) infection usually causes a progressive disease that can result in chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma (12). Diagnosis and monitoring of HCV infection are commonly based on anti-HCV assays, recombinant immunoblotting, and HCV RNA viral load in current clinical practices (13). However, anti-HCV assays have limitations, including a lack of detection sensitivity in the early window periods of 45 to 68 days after infection (5), although second-and third-generation anti-HCV assays have improved. Real-time quantitative reverse transcription-PCR (qRT-PCR) analyses for measuring viral loads also have some drawbacks. These techniques are not completely free from contamination and false-positive results. Furthermore, some PCR assays require technical skills and may also be labor intensive and expensive.HCV core antigen (Ag) tests have been introduced to supplement anti-HCV tests or HCV qRT-PCR analyses over the last decade (1, 16), and these quantitative HCV Ag assays could be used for the monitoring of antiviral therapy as well as for diagnosis of HCV infection (3, 6). Furthermore, the HCV Ag assay could also be useful in monitoring immunocompromised patients and those undergoing hemodialysis (10). However, most of the past studies detecting HCV Ag utilized enzyme-linked immunosorbent assays (ELISAs) or enzyme immunoassays (EIAs) (4,7,14,18), which may need considerable time and skills. Recently, a fully automated chemiluminescent immunoassay (CLIA) with higher sensitivity and throughput was developed to overcome shortcomings of the conventional core Ag assays (11). Thus, we evaluated the newly introduced HCV Ag assay and compared it with a quantitative RNA assay to verify the utility of this automated Ag assay as an alternative to HCV RNA qRT-PCR.A total of 282 serum samples from the 268 patients who visited a university hospital in Korea with suspected HCV infection were collected from January to April 2009. HCV Ag and qRT-PCR assays were performed for all 282 samples, while anti-HCV antibodies and liver enzymes were measured in 279 and 250 subjects, respectively. HCV genotyping was also performed in 127 specimens. Serum HCV Ag was determined by an Abbott Architect i2000SR analyzer (Abbott Laboratories, Abbott Park, IL) with an HCV Ag assay kit (Abbott Japan Co., Ltd., Tokyo, Japan). The Architect HCV Ag assay is a two-step chemiluminescent microparticle immunoassay for the quantitation of HCV core Ag. The sample volume required is about 110 l, and the total assay time is 36 min. The cutoff value is 3.0 fmol/liter; thus, HCV Ag levels below 3.0 fmol/liter were considered nonreactive. HCV RNA viral load was determi...

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Evaluation of clinical usefulness of second‐generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0

Abstract: This new assay was considered to be useful in evaluating the HCV levels in patients with chronic hepatitis C.

Cited by 10 publications

References 33 publications

HCV core antigen testing in HIV- and HBV-coinfected patients, and in HCV-infected patients on hemodialysis

HCV core antigen testing in HIV- and HBV-coinfected patients, and in HCV-infected patients on hemodialysis

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

New Automated Hepatitis C Virus (HCV) Core Antigen Assay as an Alternative to Real-Time PCR for HCV RNA Quantification

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