Distinguishing Acute from Chronic and Resolved Hepatitis C Virus (HCV) Infections by Measurement of Anti-HCV Immunoglobulin G Avidity Index

Klimashevskaya, S.; Obriadina, Anna; Ulanova, T. I.; Bochkova, G. D.; Burkov, A. N.; Araujo, A Caterino de; Stramer, Susan L.; Tobler, Leslie H.; Busch, Michael P.; Fields, Howard A.

doi:10.1128/jcm.01012-07

Cited by 34 publications

(40 citation statements)

References 17 publications

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“…16,19,23 Previous studies have found that patients with resolved HCV infection can have a lower avidity index compared to chronic patients whose antibodies are continually exposed to the HCV virus. [16][17][18][19] A testing algorithm has been developed for HCV avidity using either plasma or DBS. In our laboratory we found that two dilution factors were required to help differentiate between chronic and resolved infections when the sample had an AI < 30 and was PCR negative.…”

Section: Discussionmentioning

confidence: 99%

“…Several papers have addressed HCV avidity testing but all have been described using plasma/serum samples. [15][16][17][18][19] All the HCV avidity methods reported are modifications of commercial or in house ELISA kits using either guanidine or urea as the DA. The method described in this paper uses a modified commercial assay with an overnight incubation stage for HCV avidity testing.…”

Section: Introductionmentioning

confidence: 99%

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A hepatitis C avidity test for determining recent and past infections in both plasma and dried blood spots

Shepherd

Kean

Hutchinson

et al. 2013

Journal of Clinical Virology

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This version is available at https://strathprints.strath.ac.uk/42887/ Strathprints is designed to allow users to access the research output of the University of Strathclyde. Unless otherwise explicitly stated on the manuscript, Copyright © and Moral Rights for the papers on this site are retained by the individual authors and/or other copyright owners. Please check the manuscript for details of any other licences that may have been applied. You may not engage in further distribution of the material for any profitmaking activities or any commercial gain. You may freely distribute both the url (https://strathprints.strath.ac.uk/) and the content of this paper for research or private study, educational, or not-for-profit purposes without prior permission or charge.Any correspondence concerning this service should be sent to the Strathprints administrator: strathprints@strath.ac.ukThe Strathprints institutional repository (https://strathprints.strath.ac.uk) is a digital archive of University of Strathclyde research outputs. It has been developed to disseminate open access research outputs, expose data about those outputs, and enable the management and persistent access to Strathclyde's intellectual output. a b s t r a c tBackground: DBS testing has been used successfully to detect HCV antibody positive individuals. Determining how long someone has been infected is important for surveillance initiatives. Antibody avidity is a method that can be used to calculate recency of infection. Objectives: A HCV avidity assay was evaluated for both plasma and DBS. Study design: To measure antibody avidity a commercial HCV ELISA was modified using 7 M urea. The plasma samples were split into: group 1 (recently infected N = 19), group 2 (chronic carrier N = 300) and group 3 (resolved infection N = 82). Mock DBS made from group 1 (N = 12), group 2 (N = 50), group 3 (N = 25) and two seroconverter panels were evaluated. 133 DBS taken from patients known to have a resolved infection or be a chronic carrier were also tested.Results: The avidity assay cut-off was set at AI ≤ 30 for a recent infection. Using sequential samples the assay could detect a recent infection in the first 4-5 months from the point of infection. Most of the false positive results (AI < 30 among cases known not to have had recent infection) were detected among known resolved infections, in both the plasma and DBS; as a result, a testing algorithm has been designed incorporating both PCR and two dilution factors. The sensitivity and specificity of the assay on plasma was 100% and 99.3%, respectively, while DBS had 100% sensitivity and 98.3% specificity. Conclusion:The HCV avidity assay can be used to distinguish between chronic and recent infection using either plasma or DBS as the sample type.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A hepatitis C avidity test for determining recent and past infections in both plasma and dried blood spots

Shepherd

Kean

Hutchinson

et al. 2013

Journal of Clinical Virology

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“…The chronic hepatitis C patients (the "chronic" group) consisted of anti-HCVIgG-positive plasma samples from 141 blood donors: 64 samples were from BBI, and 77 were from the American Red Cross (9). All samples were confirmed to contain anti-HCV IgG by the Ortho recombinant immunoblot assay (RIBA) and HCV RNA by reverse transcriptase PCR (9).…”

Section: Methodsmentioning

confidence: 99%

“…Further, distinguishing acute from chronic infection on the basis of clinical history, epidemiological risk factors, and symptoms can be difficult because for most patients acute infection is asymptomatic (12,3). Several approaches, which include detection of anti-HCV IgM (4,2), measurement of the anti-HCV IgG avidity index (9), and observation of serial changes in viral load (10), have been proposed as indicators of acute HCV infection. The usefulness of anti-HCV IgM as a marker of acute infection remains controversial (4,2).…”

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confidence: 99%

Distinguishing Acute from Chronic Hepatitis C Virus (HCV) Infection Based on Antibody Reactivities to Specific HCV Structural and Nonstructural Proteins

et al. 2011

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Currently available serological assays for detection of antibodies to hepatitis C virus (HCV) cannot reliably discriminate acute from chronic HCV infection. We developed a multiplexed, flow-cytometric microsphere immunoassay to measure anti-HCV-IgG reactivities to the core, NS3, NS4, and NS5 HCV recombinant proteins and applied it to 99 serum samples from 24 anti-HCV seroconverters and 141 anti-HCV-IgG and HCV RNA-positive plasma specimens from chronically infected people. Differences in the geometric means or means of signal/cutoff ratios between the two sample sets were statistically significant for all the antigens tested. A multivariate logistic regression model correctly classified the samples in two groups, with a cross-validation accuracy of 90.8% for the acute group and 97.2% for the chronic group. The immunoassay described has the potential to distinguish acute from chronic HCV infection.The diagnosis of acute hepatitis C virus (HCV) infection is based on the detection in serum or plasma of HCV RNA, anti-HCV IgG, and elevation of alanine aminotransferase levels (5). However, none of these markers alone or in combination can be used to identify acute infection, since they may also be detectable during the chronic phase of infection. Further, distinguishing acute from chronic infection on the basis of clinical history, epidemiological risk factors, and symptoms can be difficult because for most patients acute infection is asymptomatic (12, 3). Several approaches, which include detection of anti-HCV IgM (4, 2), measurement of the anti-HCV IgG avidity index (9), and observation of serial changes in viral load (10), have been proposed as indicators of acute HCV infection. The usefulness of anti-HCV IgM as a marker of acute infection remains controversial (4, 2). The recently published approach of using viral load fluctuations to identify acute HCV infection requires serial testing of samples (10). We report here the development of a high-throughput microsphere immunoassay, which simultaneously detects anti-HCV IgG responses to multiple structural and nonstructural HCV recombinant proteins, and its application to serum and plasma samples collected from people in the acute and chronic phases of HCV infection. The assay has the potential to discriminate between the acute and chronic phases by testing of single specimens. MATERIALS AND METHODSStudy serum specimens. This study was performed using unlinked anonymous serum or plasma specimens and specimens obtained commercially from blood donor anti-HCV seroconversion panels. Ninety-nine plasma samples were obtained from 24 donor panels; the number of samples per panel varied between 1 and 11. Ten panels were acquired from Zeptometrix (Buffalo, NY) (batch numbers 6211, 6212, 6213, 6214, 6215, 9041, 9047, 9054, 9055, and 9058), 5 from NABI (Boca Raton, FL) (batch numbers 10, 20, 30, 40, and 60), 4 from Serologicals (Clarkston, GA) (batch numbers 4812B, 4813, 4814, and 4814B), 3 panels (batch numbers 908, 920, and 921) from BBI (West Bridgewater, MA), and 2 from Prof...

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“…However, the limited evaluation of such assays in small populations has hampered their development for use in clinical practice. More recently, the development of an "inhouse" anti-HCV IgG avidity assay, using a combination of target antigens, has been validated with seroconversion panels and samples from chronically infected individuals (12).…”

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confidence: 99%

Use of an Anti-Hepatitis C Virus (HCV) IgG Avidity Assay To Identify Recent HCV Infection

et al. 2010

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There is no reliable and simple diagnostic marker available to diagnose recent hepatitis C virus (HCV) infection. It has been shown that the avidity of specific IgG antibody is low in primary viral infection and increases with time. We report the development of an anti-HCV avidity assay derived from a commercially available test. A panel of 117 sera was first examined for IgG avidity. It was composed of samples from patients with recent (group 1, n ‫؍‬ 14), chronic (group 2, n ‫؍‬ 70), and resolved (group 3, n ‫؍‬ 33) HCV infections. Avidity index (AI) values observed in recently infected patients were significantly lower (12.0% ؎ 9.2% [mean ؎ standard deviation]) than those found in chronic carriers (83.1% ؎ 15.2%). Using a threshold of 43.0%, this assay distinguished between groups 1 and 2 with very high sensitivity (98%) and specificity (100%). For group 3, a broader distribution of the AI values was observed (54.8% ؎ 27.3%), suggesting that this index would not be useful in HCV RNA-negative patients. Blind validation of the test was carried out with a panel of 36 serum samples from 17 HCV seroconverters. The assay described here is a useful tool to distinguish recent from chronic infection in HCV-viremic patients.

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Distinguishing Acute from Chronic and Resolved Hepatitis C Virus (HCV) Infections by Measurement of Anti-HCV Immunoglobulin G Avidity Index

Cited by 34 publications

References 17 publications

A hepatitis C avidity test for determining recent and past infections in both plasma and dried blood spots

A hepatitis C avidity test for determining recent and past infections in both plasma and dried blood spots

Distinguishing Acute from Chronic Hepatitis C Virus (HCV) Infection Based on Antibody Reactivities to Specific HCV Structural and Nonstructural Proteins

Use of an Anti-Hepatitis C Virus (HCV) IgG Avidity Assay To Identify Recent HCV Infection

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