Evaluation of newly developed microparticle enzyme immunoassays for the detection of HCV antibodies

Hennig, Holger; Schlenke, Peter; Kirchner, Holger; Bauer, Irma; Schulte-Kellinghaus, B.; Bludau, H.

doi:10.1016/s0166-0934(99)00146-9

Cited by 24 publications

(15 citation statements)

References 13 publications

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“…29 Our data were obtained using the AxSYM 3.0 (Abbott) assay that detects antibodies to proteins that are conserved across HCV genotypes. 30 The manufacturers claim this includes genotype 5 (the most common type of HCV seen in South Africa 31,32 ) but no genotype 5 sensitivity data are available for evaluation. The low prevalence of HCV in this cohort is attributed to HIV transmission via sexual contact (an uncommon route of HCV transmission) rather than through injecting drug use.…”

mentioning

confidence: 99%

Hepatitis C seropositivity is not a risk factor for sensory neuropathy among patients with HIV

Cherry¹,

Affandi²,

Brew³

et al. 2010

Neurology

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confidence: 99%

Hepatitis C seropositivity is not a risk factor for sensory neuropathy among patients with HIV

Cherry¹,

Affandi²,

Brew³

et al. 2010

Neurology

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“…The first-and the second-generation anti-HCV enzyme immunoassays, thus, had important limitations, notably, a high rate of false-positive and -negative results (7, 18). To increase both sensitivity and specificity, a greater number of HCV-encoded antigens are now included in the third-generation enzyme immunoassay (EIA), allowing an increase in the specificity (8,19). The addition of core and NS5 region-encoded antigens on the solid phase of serological assays also resulted in earlier detection of anti-HCV during acute infection, a marked increase in the sensitivity, and a dramatic reduction in the incidence of posttransfusion hepatitis in blood banks (25).…”

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confidence: 99%

Laboratory Evaluation of a Fully Automated Chemiluminescence Immunoassay for Rapid Detection of HBsAg, Antibodies to HBsAg, and Antibodies to Hepatitis C Virus

2004

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The performance of a fully automated, random access, enhanced chemiluminescence immunoassay (Ortho/ ECi) for the detection of antibody to hepatitis C virus (HCV) (anti-HCV), HBsAg, and antibody to HBsAg (anti-HBsAg), in human serum was compared to a Abbott second-generation enzyme immunoassay (EIA 2.0). The Ortho/ECi assays employ an immunometric technique with enhanced chemiluminescence for optimal assay performance. With regard to the study of clinical laboratory performance, six groups of sera prescreened with Abbott EIAs were assayed: anti-HCV-negative samples (n ‫؍‬ 318), anti-HCV-positive samples (n ‫؍‬ 177), anti-HBsAg-negative samples (n ‫؍‬ 241), anti-HBsAg-positive samples (n ‫؍‬ 239), HBsAg-positive samples (n ‫؍‬ 158), and HBsAg-negative samples (n ‫؍‬ 312). Sera with discrepant results in the two serological assays were resolved by confirmatory tests. Sera with indeterminate results by one or more confirmatory tests were evaluated by reviewing medical records. The overall concordance between the Ortho/ECi assay and the Abbott EIA were 97.78, 93.54, and 97.66% for anti-HCV antibodies, anti-HBsAg antibodies, and HBsAg, respectively. After resolving the discrepancies, the specificities of the new assay for anti-HCV and anti-HBsAg antibodies and HBsAg were 98.1, 92.8, and 100%, respectively. The sensitivities of the new assay for anti-HCV, anti-HBsAg, and HBsAg were 100, 98.8, and 97.4%, respectively. In conclusion, The Ortho/ECi assays for diagnosis of HCV and hepatitis B virus (HBV) infections are highly specific and sensitive assays. The rapid turnaround time, random access, full automation, and high throughput make it an effective assay system for clinical laboratory diagnosis of HCV and HBV infections.The four immunoassays described here are associated with the diagnosis of hepatitis C and B virus (HCV and HBV, respectively) infections. HCV, an enveloped positive-stranded RNA virus of the Flaviviridae family, has been demonstrated to be the etiologic agent of 90% of chronic non-A, non-B hepatitis (2, 5, 10, 15). HCV infection is often asymptomatic; however, the vast majority of HCV-infected individuals (Ͼ85%) develop persistent chronic infection and chronic hepatitis (9,32,45,46). Diagnosis of HCV infection has serious implications, especially for the high-risk patients such as those undergoing hemodialysis (20,27,35). The presence of anti-HCV antibodies indicates that an individual may have been infected with HCV and/or may be capable of transmitting HCV infection while active infection is marked by the presence of HCV RNA detected by reverse transcriptase PCR (6,17,35,42). Detection of viremia is often required in certain cases of acute infection and/or immunodeficiency, where individuals may fail to produce antibodies specific for HCV (32, 39).The HCV genome consists of seven functional regions: the core, the envelope, including the E1 and E2 regions, and the nonstructural region, including NS2, NS3, NS4, and NS5 (31). The first commercially available HCV test was an enzymelinked immunosorbent a...

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“…Anti-HCV detection is widely diffuse and used as the screening procedure in the clinical practise. In fact, the development of semi-and fully-automated methods makes the methods easy and rapid to perform and the data highly reproducible [3,4]. Despite the advances in serological diagnostic capability in relation to HCV infection over the past 14 years, a number of controversial aspects remain object of discussion and debate.…”

Section: Discussionmentioning

confidence: 99%

“…In the last years, particular attention has been paid to the research of a better specificity and better antigen combination, in order to reduce the frequency of results initially reactive that needed subsequent analysis with supplementary tests. In addition, efforts were made in the technological field, direct to develop semior fully-automated methods [3,4]. This research has concurred to significantly reduce the turnaround time and obtain a better analytical control.…”

Section: Introductionmentioning

confidence: 99%

External quality assurance program in anti-HCV serological detection: an Italian experience

Vassalle

Mercuri

Masini

et al. 2004

Immuno-analyse & Biologie Spécialisée

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Evaluation of newly developed microparticle enzyme immunoassays for the detection of HCV antibodies

Cited by 24 publications

References 13 publications

Hepatitis C seropositivity is not a risk factor for sensory neuropathy among patients with HIV

Hepatitis C seropositivity is not a risk factor for sensory neuropathy among patients with HIV

Laboratory Evaluation of a Fully Automated Chemiluminescence Immunoassay for Rapid Detection of HBsAg, Antibodies to HBsAg, and Antibodies to Hepatitis C Virus

External quality assurance program in anti-HCV serological detection: an Italian experience

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