{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T17:39:50Z","timestamp":1788716390116,"version":"build-2803163510"},"reference-count":35,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005062","name":"Fujirebio Europe","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti\u2010HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource\u2010limited countries. Hepatitis B core\u2010related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ &lt;15\/assay) and strong correlation with HBV DNA levels in treatment\u2010na\u00efve 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\u2010infected people with high viraemia. We evaluated the following elution method optimized to quantify HBcrAg: suspension of a punched blood\u2010soaked disc (11\u00a0mm) of Whatman 903 Protein Saver Card in 450\u00a0\u00b5L of PBS 0.05% Tween 20, followed by an incubation for 4\u00a0h at room temperature and a centrifugation at 10,000\u00a0<jats:italic>g<\/jats:italic> for 10\u00a0minutes. 150\u00a0\u00b5L of DBS eluate was used to quantify HBcrAg using chemiluminescent enzyme immunoassay (LUMIPULSE<jats:sup>\u00ae<\/jats:sup> G600II, Fujirebio). The limit of detection of dried blood spot HBcrAg in relation with HBV DNA levels was 19,115\u00a0IU\/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 (<jats:italic>r<\/jats:italic>\u00a0=\u00a00.94, <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.0001) in samples with high viral loads (range: 3.7\u20137.0 log IU\/mL). The coefficient of variation ranged between 4.0\u201311.2% for repeatability and 3.9\u201312.2% for reproducibility. Analytical specificity was 100% (95% CI: 83.9\u2013100%) in HBV\u2010negative samples. Using our elution method, it may be possible to identify HBV\u2010infected patients with high viraemia who need antiviral therapy using dried blood spot and HBcrAg. A large\u2010scale clinical validation is warranted in resource\u2010limited countries.<\/jats:p>","DOI":"10.1111\/jvh.13489","type":"journal-article","created":{"date-parts":[[2021,2,18]],"date-time":"2021-02-18T06:51:29Z","timestamp":1613631089000},"page":"837-843","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Analytical validation of hepatitis B core\u2010related antigen (HBcrAg) using dried blood spots (DBS)"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4198-4785","authenticated-orcid":false,"given":"Yusuke","family":"Shimakawa","sequence":"first","affiliation":[{"name":"Unit\u00e9 d'\u00c9pid\u00e9miologie des Maladies \u00c9mergentes Institut Pasteur  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Vernoux","sequence":"additional","affiliation":[{"name":"Fujirebio Europe  Gent Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Gabassi","sequence":"additional","affiliation":[{"name":"Laboratoire de Virologie H\u00f4pital Saint\u2010Louis AP\u2010HP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Mercier\u2010Delarue","sequence":"additional","affiliation":[{"name":"Laboratoire de Virologie H\u00f4pital Saint\u2010Louis AP\u2010HP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne Perp\u00e9tue","family":"Vincent","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'\u00c9pid\u00e9miologie des Maladies \u00c9mergentes Institut Pasteur  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Simon","sequence":"additional","affiliation":[{"name":"Laboratoire de Virologie H\u00f4pital Saint\u2010Louis AP\u2010HP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Maylin","sequence":"additional","affiliation":[{"name":"Laboratoire de Virologie H\u00f4pital Saint\u2010Louis AP\u2010HP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"WHO.Global Health Sector Strategy on Viral Hepatitis 2016\u20132021. 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