Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS)
Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti‐HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource‐limited countries. Hepatitis B core‐related antigen (HBcrAg) has the potential to b...
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Veröffentlicht in: | Journal of viral hepatitis 2021-05, Vol.28 (5), p.837-843 |
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creator | Shimakawa, Yusuke Vernoux, Laura Gabassi, Audrey Mercier‐Delarue, Séverine Vincent, Jeanne Perpétue Simon, François Maylin, Sarah |
description | Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti‐HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource‐limited countries. Hepatitis B core‐related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ |
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Hepatitis B core‐related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ <15/assay) and strong correlation with HBV DNA levels in treatment‐naïve patients. However, the current assay requires plasma or serum. To further facilitate its application to decentralized settings, we developed and evaluated a standardized procedure to quantify HBcrAg using dried blood spots as a tool to diagnose HBV‐infected people with high viraemia. We evaluated the following elution method optimized to quantify HBcrAg: suspension of a punched blood‐soaked disc (11 mm) of Whatman 903 Protein Saver Card in 450 µL of PBS 0.05% Tween 20, followed by an incubation for 4 h at room temperature and a centrifugation at 10,000 g for 10 minutes. 150 µL of DBS eluate was used to quantify HBcrAg using chemiluminescent enzyme immunoassay (LUMIPULSE® G600II, Fujirebio). The limit of detection of dried blood spot HBcrAg in relation with HBV DNA levels was 19,115 IU/mL across the five major HBV genotypes (A/B/C/D/E). A strong linear correlation was confirmed between dried blood spot HBcrAg and HBV DNA levels (r = 0.94, p < 0.0001) in samples with high viral loads (range: 3.7–7.0 log IU/mL). The coefficient of variation ranged between 4.0–11.2% for repeatability and 3.9–12.2% for reproducibility. Analytical specificity was 100% (95% CI: 83.9–100%) in HBV‐negative samples. Using our elution method, it may be possible to identify HBV‐infected patients with high viraemia who need antiviral therapy using dried blood spot and HBcrAg. A large‐scale clinical validation is warranted in resource‐limited countries.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.13489</identifier><identifier>PMID: 33599049</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>analytical validation ; Antigens ; Antiviral agents ; Blood ; Centrifugation ; Deoxyribonucleic acid ; diagnostic test ; DNA ; dried blood spot ; Elution ; Enzyme immunoassay ; Genotypes ; Hepatitis ; Hepatitis B ; hepatitis B core‐related antigen ; Life Sciences ; Original ; Patients ; resource‐limited country ; Santé publique et épidémiologie ; Viremia</subject><ispartof>Journal of viral hepatitis, 2021-05, Vol.28 (5), p.837-843</ispartof><rights>2021 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2021 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd.</rights><rights>2021. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). 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Hepatitis B core‐related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ <15/assay) and strong correlation with HBV DNA levels in treatment‐naïve patients. However, the current assay requires plasma or serum. To further facilitate its application to decentralized settings, we developed and evaluated a standardized procedure to quantify HBcrAg using dried blood spots as a tool to diagnose HBV‐infected people with high viraemia. We evaluated the following elution method optimized to quantify HBcrAg: suspension of a punched blood‐soaked disc (11 mm) of Whatman 903 Protein Saver Card in 450 µL of PBS 0.05% Tween 20, followed by an incubation for 4 h at room temperature and a centrifugation at 10,000 g for 10 minutes. 150 µL of DBS eluate was used to quantify HBcrAg using chemiluminescent enzyme immunoassay (LUMIPULSE® G600II, Fujirebio). The limit of detection of dried blood spot HBcrAg in relation with HBV DNA levels was 19,115 IU/mL across the five major HBV genotypes (A/B/C/D/E). A strong linear correlation was confirmed between dried blood spot HBcrAg and HBV DNA levels (r = 0.94, p < 0.0001) in samples with high viral loads (range: 3.7–7.0 log IU/mL). The coefficient of variation ranged between 4.0–11.2% for repeatability and 3.9–12.2% for reproducibility. Analytical specificity was 100% (95% CI: 83.9–100%) in HBV‐negative samples. Using our elution method, it may be possible to identify HBV‐infected patients with high viraemia who need antiviral therapy using dried blood spot and HBcrAg. A large‐scale clinical validation is warranted in resource‐limited countries.</description><subject>analytical validation</subject><subject>Antigens</subject><subject>Antiviral agents</subject><subject>Blood</subject><subject>Centrifugation</subject><subject>Deoxyribonucleic acid</subject><subject>diagnostic test</subject><subject>DNA</subject><subject>dried blood spot</subject><subject>Elution</subject><subject>Enzyme immunoassay</subject><subject>Genotypes</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>hepatitis B core‐related antigen</subject><subject>Life Sciences</subject><subject>Original</subject><subject>Patients</subject><subject>resource‐limited country</subject><subject>Santé publique et épidémiologie</subject><subject>Viremia</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNp1kU-PEyEYh4nRuOvqwS9gSLy0h9mFAWbgYtKuf6pp4sGNV8IA09LQYYSZbnrzI_gZ_SRSZ93oJnLhTd6H5wV-ALzE6BLndbU7bC8xoVw8AueYVKwouSCPTzUrC8QQPQPPUtohhEnJ8FNwRggTAlFxDppFp_xxcFp5eFDeGTW40MHQwq3tcz24BJdQh2h_fv8RrVeDNVB1g9vYDs5WSx0Xmzkck-s20ESXm40PwcDUhyHB2dvll_lz8KRVPtkXd_sFuHn_7uZ6Vaw_f_h4vVgXmnIsCi14RYVq25oJ1tRYm4rxklBdtpw3GFlquKmsYgJpgjBtayRs01BUK1ZqQy7Am0nbj83eGm27ISov--j2Kh5lUE7-2-ncVm7CQfKS1oKzLCgmwfbBsdViLXuVBjtGiUgl6pqSA8787G5gDN9Gmwa5d0lb71Vnw5hkSQVGHOFKZPT1A3QXxph_PlMMs1oQgU7UfKJ0DClF297fAiN5ClrmoOXvoDP76u_X3pN_ks3A1QTcOm-P_zfJT19Xk_IXhL2yWA</recordid><startdate>202105</startdate><enddate>202105</enddate><creator>Shimakawa, Yusuke</creator><creator>Vernoux, Laura</creator><creator>Gabassi, Audrey</creator><creator>Mercier‐Delarue, Séverine</creator><creator>Vincent, Jeanne Perpétue</creator><creator>Simon, François</creator><creator>Maylin, Sarah</creator><general>Wiley Subscription Services, Inc</general><general>Wiley-Blackwell</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-4198-4785</orcidid></search><sort><creationdate>202105</creationdate><title>Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS)</title><author>Shimakawa, Yusuke ; Vernoux, Laura ; Gabassi, Audrey ; Mercier‐Delarue, Séverine ; Vincent, Jeanne Perpétue ; Simon, François ; Maylin, Sarah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4819-c98649aff7595b71cd658234c2f88b10e4d8d6ea590c3014f709ebb407a52cd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>analytical validation</topic><topic>Antigens</topic><topic>Antiviral agents</topic><topic>Blood</topic><topic>Centrifugation</topic><topic>Deoxyribonucleic acid</topic><topic>diagnostic test</topic><topic>DNA</topic><topic>dried blood spot</topic><topic>Elution</topic><topic>Enzyme immunoassay</topic><topic>Genotypes</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>hepatitis B core‐related antigen</topic><topic>Life Sciences</topic><topic>Original</topic><topic>Patients</topic><topic>resource‐limited country</topic><topic>Santé publique et épidémiologie</topic><topic>Viremia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shimakawa, Yusuke</creatorcontrib><creatorcontrib>Vernoux, Laura</creatorcontrib><creatorcontrib>Gabassi, Audrey</creatorcontrib><creatorcontrib>Mercier‐Delarue, Séverine</creatorcontrib><creatorcontrib>Vincent, Jeanne Perpétue</creatorcontrib><creatorcontrib>Simon, François</creatorcontrib><creatorcontrib>Maylin, Sarah</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shimakawa, Yusuke</au><au>Vernoux, Laura</au><au>Gabassi, Audrey</au><au>Mercier‐Delarue, Séverine</au><au>Vincent, Jeanne Perpétue</au><au>Simon, François</au><au>Maylin, Sarah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS)</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2021-05</date><risdate>2021</risdate><volume>28</volume><issue>5</issue><spage>837</spage><epage>843</epage><pages>837-843</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti‐HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource‐limited countries. Hepatitis B core‐related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ <15/assay) and strong correlation with HBV DNA levels in treatment‐naïve patients. However, the current assay requires plasma or serum. To further facilitate its application to decentralized settings, we developed and evaluated a standardized procedure to quantify HBcrAg using dried blood spots as a tool to diagnose HBV‐infected people with high viraemia. We evaluated the following elution method optimized to quantify HBcrAg: suspension of a punched blood‐soaked disc (11 mm) of Whatman 903 Protein Saver Card in 450 µL of PBS 0.05% Tween 20, followed by an incubation for 4 h at room temperature and a centrifugation at 10,000 g for 10 minutes. 150 µL of DBS eluate was used to quantify HBcrAg using chemiluminescent enzyme immunoassay (LUMIPULSE® G600II, Fujirebio). The limit of detection of dried blood spot HBcrAg in relation with HBV DNA levels was 19,115 IU/mL across the five major HBV genotypes (A/B/C/D/E). A strong linear correlation was confirmed between dried blood spot HBcrAg and HBV DNA levels (r = 0.94, p < 0.0001) in samples with high viral loads (range: 3.7–7.0 log IU/mL). The coefficient of variation ranged between 4.0–11.2% for repeatability and 3.9–12.2% for reproducibility. Analytical specificity was 100% (95% CI: 83.9–100%) in HBV‐negative samples. Using our elution method, it may be possible to identify HBV‐infected patients with high viraemia who need antiviral therapy using dried blood spot and HBcrAg. A large‐scale clinical validation is warranted in resource‐limited countries.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33599049</pmid><doi>10.1111/jvh.13489</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-4198-4785</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | analytical validation Antigens Antiviral agents Blood Centrifugation Deoxyribonucleic acid diagnostic test DNA dried blood spot Elution Enzyme immunoassay Genotypes Hepatitis Hepatitis B hepatitis B core‐related antigen Life Sciences Original Patients resource‐limited country Santé publique et épidémiologie Viremia |
title | Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS) |
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