Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Berger, Annemarie; Rabenau, Holger F.; Allwinn, Regina; Doerr, Hans Wilhelm

doi:10.1016/j.jcv.2008.05.009

Cited by 31 publications

(28 citation statements)

References 9 publications

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“…These five samples tested negative in both Architect and Procleix PCR assays, but were weakly test-positive in the VIDAS assay (TV 1.05-6.23). Such discrepant results between immunoassays have been reported elsewhere, especially for samples with low S/CO ratios, and may be due to random errors, differences in antigens or epitopes, or differences in labeling substances for signal detection in the assays [78910]. The Architect test is a two-step immunoassay based on the chemiluminescent microparticle immunoassay and employs the Hcr43 recombinant fusion protein (Core, NS3; expressed in E. coli ) and the c100-3 recombinant protein (NS4; expressed in yeast) as antigens.…”

Section: Discussionmentioning

confidence: 95%

“…Several studies have analyzed the correlation between Architect, Elecsys, and Vitros (Ortho-Clinical Diagnostics, Raritan, NJ, USA) anti-HCV antibody assays and showed a strong correlation between Architect and Vitros assays because of the use of the same recombinant antigens under contract agreement between the two manufacturers [781016]. The weak correlation between VIDAS and Architect assays was probably due to the differences in antigens or epitopes or labeling substances for signal detection, as mentioned above.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

Hyun

Kang

et al. 2016

Ann Lab Med

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BackgroundAnti-hepatitis C virus antibody (anti-HCV) assays are recommended for screening HCV-infected persons. The VIDAS Anti-HCV Assay (bioMérieux, France), based on the enzyme-linked fluorescence test principle, was recently introduced in Korea. We evaluated the clinical performance of the VIDAS assay.MethodsOne hundred HCV-positive and 1,002 HCV-negative blood samples confirmed by Architect anti-HCV (Abbott Laboratories, USA) and COBAS TaqMan HCV real-time PCR (Roche Diagnostics, USA) or the Procleix Ultrio Plus Assay (Gen-Probe Incorporated, USA) were obtained from the Human Serum Bank (HSB) and tested by VIDAS. In case of discrepant results, we conducted a recombinant immunoblot assay (RIBA).ResultsThe agreement rates for known HCV-positive and HCV-negative samples between the VIDAS assay and the HSB testing were 100% (95% confidence interval [CI]: 96.4-100%) and 99.5% (95% CI: 98.8-99.8%), respectively. One of the five discrepant samples was positive for Core 2+ and NS3-2 2+ reactivity, two samples were negative, and the other two were indeterminate regarding NS4 2+ reactivity in RIBA. We observed a significant but weak positive correlation between the titers of VIDAS and Architect assays (r=0.315, P<0.001).ConclusionsThe VIDAS anti-HCV assay, developed on the VIDAS automated immunoassay platform based on the ready-to-use, single-sample test concept may be useful in small-to-medium-sized laboratories. It showed good agreement with Architect anti-HCV and COBAS PCR assays and is therefore useful for detection of HCV infection. Weakly test-positive (ambiguous) samples require additional testing by another anti-HCV, RIBA, or HCV RNA assay.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

Hyun

Kang

et al. 2016

Ann Lab Med

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“…Some viruses, such as HCV and HIV, can duplicate in very low concentration in the host and so the early infection period diagnosis is very important in such diseases [1][2][3][4][5]. Diagnosis depends on the sensitivity of the detection method and, generally, the lower the detection limit, the shorter the window period between infection and diagnosis [4][5][6][7].…”

Section: Introductionmentioning

confidence: 99%

“…However, high signal amplification is by far not the only issue the analysts are focusing on in the immunoassays. The lower limitation of detection (LOD) which is affected by nonspecific binding and other aspects is as important as the sensitivity [1][2][3][4]12,13]. High signal amplification systems increase the analyte signal; however, they will amplify the nonspecific binding and background signals at the same time, especially in the solid-phase fluorescent immunoassays.…”

Section: Introductionmentioning

confidence: 99%

An Organic Nanoparticle based High Signal Amplification Immunoassay with Improvement of Nonspecific Binding

Cao¹

2014

J Nanomed Nanotechnol

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A high signal amplification immunoassay method based on Fluorescein Diacetate (FDA) organic nanoparticle was proposed here. FDA nanoparticles were prepared in a ball mill and centrifugation was applied to get the size-uniformed SDS stabilized particle (FDA@SDS). Further SEM images confirmed the particle size was well dispersed in solution and particle size analysis results showed that the particle size 90% was distributed in the range of 200 nm to 500 nm. Mass Spectrometry results showed that the antibody can directly attach to the FDA@SDS particles and standard sandwich immunoassay confirmed the bioactivity of the antibody on the FDA@SDS particle surface (FDA@SDS-IgG). And then Zeta potential test results showed that the blocking reagents BSA and Casein can successfully block the unsatisfied sites on the FDA@SDS-IgG surface, which resulted in the improvement of nonspecific binding and stabilization. Further experiments were carried out using the standard immunoassays which showed the analyte signal can be greatly amplified when Casein was used as block buffer in the immunoassays. The limitation of detection was lower than 10 pg/mL, which is 100 times lower than Cy3 or FITC directly labeled antibody. The improved procedure simplifies previously reported protocols and provides a simple high signal amplification immunoassay.

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“…A major problem with current screening assays is false-positive results (4,11,35). Blood donors comprise a population with low prevalence of infection; thus the sensitivity of screening immunoassays is maintained to be high in order to make sure HCV infection does not go undetected.…”

Section: Introductionmentioning

confidence: 99%

A Bioinformatics Approach to Identify Natural Autoantibodies from Healthy Blood Donors' Sera Reactive with the HCV NS5A-Derived Peptide by Immunoassay

Vasiljević¹,

Veljković²,

Kosec³

et al. 2011

Viral Immunology

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Natural autoantibodies (NAbs) are continually produced throughout life and have an ability to recognize self and altered self, as well as foreign antigens, by recognizing cellular pattern recognition receptors. Sometimes NAb specificity demonstrates overlap between human and pathologic proteomes. This information can be useful in selecting target sequences for screening purposes. In this study we undertook a multi-step bioinformatics search to predict a virus-derived peptide that can be recognized by NAbs in sera of uninfected individuals. We selected protein hepatitis C virus (HCV) NS5A as a target sequence, motivated by the fact that the HCV proteome is characterized by extensive sequence similarities to the human proteome, and because screening for anti-HCV antibodies, including anti-NS5A, is important clinically, particularly in screening of potential blood donors. The virus-specific peptide P1, and the homologous human peptide derived from enzyme-inducible nitric oxide synthase (iNOS), P2, exhibiting not only simple homology, but also complementarities of physicochemical patterns, were synthesized and 80 HCV-negative and 50 HCV-positive blood donor sera were tested by ELISA. These peptides reacted similarly (p<0.001) with HCV-negative sera, and in several cases the measured reactivity was significantly above the cut-off value of commercial anti-HCV screening assays. In HCV-positive sera, the titers of antibodies reactive with analyzed HCV NS5A peptide were not significantly increased (p<0.001) compared to host peptide, the implications of which are unclear, but may be consistent with these antibodies being "naturally produced." Finally, we extended our bioinformatics analyses to the dataset of human self-binding sequences, and propose a general approach for the selection of specific diagnostic and screening antigens for use in immunoassays.

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Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Cited by 31 publications

References 9 publications

Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

An Organic Nanoparticle based High Signal Amplification Immunoassay with Improvement of Nonspecific Binding

A Bioinformatics Approach to Identify Natural Autoantibodies from Healthy Blood Donors' Sera Reactive with the HCV NS5A-Derived Peptide by Immunoassay

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