Performance characteristics of the ARCHITECT® Anti-HCV assay

Jonas, Gesa; Pelzer, Claudia; Beckert, Christian; Hausmann, Michael; Kapprell, Hans-Peter

doi:10.1016/j.jcv.2005.08.001

Cited by 29 publications

(14 citation statements)

References 22 publications

(16 reference statements)

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“…For this reason the diluent of the assay was modified and a new study revealed an improvement of the assay not only concerning the specificity but also the sensitivity (Jonas et al, 2005).…”

Section: Discussionmentioning

confidence: 99%

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

Berger

Rabenau

Allwinn

et al. 2008

Journal of Clinical Virology

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Section: Discussionmentioning

confidence: 99%

“…This improved assay includes a modified sample dilution buffer (Jonas et al, 2005). We compared this new test version with the Vitros anti-HCV test (Ortho Clinical Diagnostics, Amersham, Bucks., UK) by testing >2000 serum samples in parallel in both systems under routine laboratory conditions.…”

Section: Introductionmentioning

confidence: 99%

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

Berger

Rabenau

Allwinn

et al. 2008

Journal of Clinical Virology

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“…Consequently, screening assays play an essential role in the diagnostic process [6]. In clinical practice, the usual approach is to test for antibodies to HCV (anti-HCV), which indicates that the individual has been infected with the virus, and then to detect HCV RNA to confirm that it is an active infection [7]. Indirect serologic tests are comparatively easy to perform and cheaper than direct tests; consequently, they are widely used as first-line assessments in screening and diagnosis.…”

Section: Introductionmentioning

confidence: 99%

Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity

Alborino

Burighel

Tiller

et al. 2010

Med Microbiol Immunol

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Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-hepatitis C (anti-HCV) antibody are valuable first-line tests in the screening and diagnosis of HCV infection. The aim of this multicenter study was to compare the Elecsys(®) Anti-HCV assay with alternative CE-marked Anti-HCV antibody assays against a range of samples that included 1,138 blood donors, 3,553 unselected routine daily specimens, and 46 pre-selected seroconversion panels. Specificity of the Elecsys Anti-HCV assay was 99.5% with blood donor samples and 99.4% with routine clinical specimens. These were similar to those obtained with the Prism(®) Anti-HCV, Architect(®) Anti-HCV assay, ADVIA(®) Centaur Anti-HCV assay and Vitros(®) Eci aHCV assays. Seroconversion sensitivity for the Elecsys Anti-HCV assay was similar to that of the Architect Anti-HCV, AxSYM HCV version 3.0, ADVIA Centaur Anti-HCV, and Vitros Eci aHCV assays. In fact, seroconversion testing on 46 commercially available panels showed that the difference in first detecting a positive blood sample was less than one day between assays (not statistically significant). The Elecsys Anti-HCV assay as well as the Architect, Prism, and Vitros Anti-HCV immunoassays revealed a seroconversion sensitivity of 100%, whereas the ADVIA Centaur HCV immunoassay showed a sensitivity of only 97.5% (39/40). Overall, the performance of the Elecsys Anti-HCV assay was similar to the performances of the comparator CE-marked Anti-HCV antibody assays.

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“…CLIA showed significantly improved specificity, a greater positive predictive value, and a similar sensitivity compared to those of EIA for detecting anti-HCV antibodies (10, 15). Although automated CLIAs are gradually replacing the EIA, there are no published studies on the comparative evaluation of automated CLIAs (10,15,16,22,27). We compared the performance of currently marketed anti-HCV automated CLIAs under routine conditions of a hospital laboratory.…”

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confidence: 99%

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

Kim

Yoon

et al. 2008

J Clin Microbiol

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Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7% with positive control materials and 7.2 to 10.2% with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1%. The clinical sensitivity of all CLIAs was 100%. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2%.Hepatitis C virus (HCV), first identified in 1989, is an enveloped positive-strand RNA virus classified in the Hepacivirus genus in the family Flaviviridae (6). The HCV genome is about 9.5 kb in length and encodes 3,011-to 3,033-amino-acid polypeptides in structural and nonstructural regions (20). The structural region contains the core protein and two envelope proteins (E1 and E2), and nonstructural proteins have been assigned protease (NS2, NS3, and NS4A), helicase (NS3), and RNA-dependent RNA polymerase (NS5B) (21) functions.The first commercially available anti-HCV enzyme immunoassay (EIA) used a single HCV recombinant antigen derived from the nonstructural NS4 protein designated c100-3 (19). The sensitivity of this first-generation EIA was low for a highprevalence population (approximately 80%) and showed a high false-positive rate (up to 70%) in a low-prevalence blood donor group (13). Therefore, a second-generation EIA was developed and approved for use by the Food and Drug Administration (FDA) in 1992 (3). The second-generation EIA, which contained additional HCV antigens from the core (c22-3) and NS3 (c33c) proteins, showed increased sensitivity and specificity and shortened the average seroconversion period from 16 to 10 weeks (1, 3, 13, 18). The third-generation EIA, which added a fourth antigen (NS5), showed significantly improved performance, particularly for high-risk patients (2, 8). However, a residual risk still exists due to the seroconversion period of approximately 56 days, and high false-positive rates were not resolved (12). The Centers for Disease Control and Prevention (CDC) recommended that an anti-HCV screening test positive result be verified by a more specific supplemental assay such as recombinant immunoblot or nucleic acid test (5). To facilitate the use of the supplemental assay, the revised guideline included an option for reflex supplemental testing based on signal-to-cutoff (s/co) ratios (4).Today, automated chemiluminescence immunoassay (...

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Performance characteristics of the ARCHITECT® Anti-HCV assay

Cited by 29 publications

References 22 publications

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

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

Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

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