Laboratory Assays for Diagnosis and Management of Hepatitis C Virus Infection

Richter, Sandra

doi:10.1128/jcm.40.12.4407-4412.2002

Cited by 90 publications

(67 citation statements)

References 42 publications

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“…The most common problem in the laboratory-screening anti-HCV assay is the false positivity of samples with low titers. Among immunocompetent populations with an anti-HCV prevalence below 10% (e.g., volunteer blood donors, military personnel, general population, health care workers, or clients attending sexually transmitted diseases clinics), the proportion of false-positive results is approximately 35% (range, 15% to 60%) (14,21,24).…”

Section: Discussionmentioning

confidence: 99%

“…Anti-HCV assays have several disadvantages, such as a high rate of false positivity, a lack of sensitivity of detection in the early window period of 45 to 68 days after infection, the inability to distinguish between acute (ongoing active, viremic), past (recovered), and persistent (chronic) infections, and a possibility of false negativity with samples from immunocompromised patients, who may not have an adequate antibody response (9,17,19,21). Recombinant immunoblot assays, types of EIAs, also have several disadvantages, such as being difficult to perform and having a high percentage of indeterminate results and a high cost.…”

mentioning

confidence: 99%

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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

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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Section: Discussionmentioning

confidence: 99%

mentioning

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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“…The detection of hepatitis C virus (HCV) RNA has become an increasingly useful tool in the diagnosis of HCV infection and in the management of patients during therapy (Richter, 2002;Lok & Gunaratnam, 1997;Chevaliez & Pawlotsky, 2006). Compared to HCV RNA testing, anti-HCV antibody immunoassays are thought to be more practicable as an initial screening test because of the ease of use, relative cost-effectiveness and low variability.…”

Section: Introductionmentioning

confidence: 99%

Double-antigen sandwich time-resolved immunofluorometric assay for the detection of anti-hepatitis C virus total antibodies with improved specificity and sensitivity

Wu¹,

Ouyan²,

Tang³

et al. 2008

Journal of Medical Microbiology

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Current anti-hepatitis C virus (HCV) antibody screening immunoassays are routinely based on an indirect format. Although their use for anti-HCV antibody detection has achieved a very high specificity and sensitivity, false-positive results are still a problem especially among populations with a low prevalence of HCV infection. One strategy to obviate this problem is to adapt the assay from an indirect format to a double-antigen sandwich one to further improve its specificity. In this study, a double-antigen sandwich time-resolved immunofluorometric assay (DAS-TRIFMA) has been developed to detect total anti-HCV antibodies based on biotin-streptavidin interaction. For comparison, 1025 samples were analysed by the DAS-TRIFMA and three indirect anti-HCV antibody detection methods. For samples with discordant results, PCR-ELISA and Inno-LIA were employed as supplementary assays to analyse the presence of HCV antibodies. With regard to the 1025 clinical samples, the overall concordance between the DAS-TRIFMA and the three indirect methods was 99.41, 98.93 and 98.93 % for Ortho ELISA 3.0, WAT ELISA and I-TRIFMA, respectively. The specificity/sensitivity of the DAS-TRIFMA, Ortho HCV ELISA 3.0, WAT HCV ELISA and I-TRIFMA were 100/99.09, 99.34/98.18, 99.23/97.27 and 99.01 %/98.18 %, respectively. The DAS-TRIFMA was able to detect HCV antibodies at a concentration about 1/10 of that detectable by indirect methods. From the obtained results and their comparison, it is concluded that the DAS-TRIFMA is a more specific and reliable method for screening anti-HCV antibodies, and weakly positive S/Co values by the DAS-TRIFMA were more predictive of HCV infection than those by indirect methods.

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“…there are diversities in terms to responce to interferone therapy among these genotypes. hcV genotype 1 and 4 are less likely to respond to interferon treatment than hcV genotype 2 or 3. therefore genotyping, might help to direct the treatment managemnet (10,13).…”

Section: Introductionmentioning

confidence: 99%

“…Genotypes 1, 2 and 3 are found throughout the world; but other genotypes are common in particular geographic regions (10). Genotype 1b is encountered as the most common genotype in the studies done in our country (1,6).…”

Section: Introductionmentioning

confidence: 99%