{"id":2988,"date":"2026-08-22T21:05:41","date_gmt":"2026-08-22T20:05:41","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?page_id=2988"},"modified":"2026-11-02T16:25:14","modified_gmt":"2026-11-02T15:25:14","slug":"what-is-disease-state-serum","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/","title":{"rendered":"Was ist \u201eDisease State Serum\u201c?"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"2988\" class=\"elementor elementor-2988\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-091eeeb e-con e-atomic-element e-flexbox-base e-default-div e-b13608b\" data-id=\"091eeeb\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"091eeeb\">\n    \t\t<div class=\"elementor-element elementor-element-6bd128d elementor-widget elementor-widget-html\" data-id=\"6bd128d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<!-- \nWORDPRESS PAGE \u2014 GUTENBERG \"BENUTZERDEFINIERTES HTML\" BLOCK\nSlug: what-is-disease-state-serum\nSEO Title: What is Disease State Serum? \u2014 Definition & IVD Use | SeamlessBio\nMeta Description: What is disease state serum, what conditions are available, and how is it used for IVD assay development, cross-reactivity testing and biomarker validation?\nFocus Keyword: what is disease state serum IVD\nAdditional Keywords: disease state serum HBV HCV HIV, pathological serum IVD development, disease state human serum biomarker\nMenu: Resources \u2192 Glossary\n-->\n<div style=\"background:#e9fbfa;border-left:4px solid #18b7b2;border-radius:0 8px 8px 0;padding:20px 24px;margin-bottom:32px;\">\n<p style=\"font-size:11px;font-weight:700;text-transform:uppercase;letter-spacing:1px;color:#139b97;margin-bottom:8px;\">Kurzdefinition<\/p>\n<p style=\"font-size:16px;margin:0;\"><strong>Was ist Disease-State-Serum?:<\/strong> Disease-State-Serum ist Humanserum von Spendern mit einer best\u00e4tigten Erkrankung \u2013 etwa HBV, HCV, HIV, rheumatoide Arthritis oder Stoffwechselerkrankungen. Es wird in der IVD-Assayentwicklung f\u00fcr Kreuzreaktivit\u00e4tstests, die Sensitivit\u00e4t an klinischen Entscheidungsgrenzen, Interferenztests und die Biomarker-Validierung in echten positiven Patientenmatrices eingesetzt.<\/p>\n<\/div>\n<h2>Wie wird Disease-State-Serum in der IVD-Entwicklung eingesetzt?<\/h2>\n<p>IVD-Zulassungsantr\u00e4ge (EU-IVDR, FDA 510(k)) verlangen den Nachweis, dass der Assay keine falsch-positiven Ergebnisse in Serum von Erkrankungen liefert, die in der getesteten Population h\u00e4ufig gleichzeitig vorkommen. F\u00fcr einen HIV-Antik\u00f6rpertest m\u00fcssen Sie zeigen, dass keine Kreuzreaktivit\u00e4t mit RF-positivem, ANA-positivem, HBV-positivem und malariapositivem Serum besteht. Disease-State-Serumpanels liefern diese Pr\u00fcfproben.<\/p>\n<p>Interferenztests (CLSI EP7) erfordern lip\u00e4misches, ikterisches und h\u00e4molytisches Serum in definierten Konzentrationen, um zu zeigen, dass \u00fcbliche Schwankungen der Probenqualit\u00e4t die Assaygenauigkeit nicht \u00fcber festgelegte Grenzen hinaus beeinflussen.<\/p>\n<h2>Wichtige Fakten<\/h2>\n<ul>\n<li>Infektionskrankheiten: HIV-1\/2-positiv, HBsAg-positiv (HBV), Anti-HCV-positiv, HCV-RNA-positiv, Syphilis-reaktiv<\/li>\n<li>Autoimmun: Rheumafaktor (RF) positiv, ANA-positiv, Anti-dsDNA, Anti-CCP \u2013 f\u00fcr Interferenztests<\/li>\n<li>Metabolisch: lip\u00e4misch (TG &gt;1.000 mg\/dl), ikterisch (Bilirubin &gt;20 mg\/dl), h\u00e4molytisch (Hb &gt;500 mg\/dl) \u2013 erforderlich nach CLSI EP7<\/li>\n<li>Endokrin: Vitamin-D-Mangel (&lt;10 ng\/ml), Hypo-\/Hyperthyreose \u2013 f\u00fcr die Entwicklung von TSH\/T3\/T4-Assays<\/li>\n<li>Geliefert mit Einwilligungsdokumentation, best\u00e4tigten Diagnosebefunden und Standard-Infektionsscreening<\/li>\n<li>Erforderlich f\u00fcr Kreuzreaktivit\u00e4ts- und Interferenzvalidierung nach EU-IVDR 2017\/746 und FDA 510(k)<\/li>\n<\/ul>\n<h2>Weiterlesen<\/h2>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/ressourcen\/blog\/disease-state-serum-biomarker-research-guide\/\">Leitfaden Disease-State-Serum<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-human-ab-serum\/\">Was ist Human Serum AB?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/produkte\/humanserum\/\">Portfolio Humanserum<\/a><\/li>\n<\/ul>\n<div style=\"background:#f4f6f7;border-radius:12px;padding:32px;text-align:center;margin-top:40px;\">\n<p style=\"font-size:18px;font-weight:700;color:#1a2e35;margin-bottom:12px;\">Disease-State-Serum \u2013 auf Anfrage bei SeamlessBio<\/p>\n<a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" style=\"background:#18b7b2;color:#fff;padding:12px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Zum Produkt \u2192<\/a>\n&nbsp;&nbsp;\n<a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" style=\"border:2px solid #18b7b2;color:#139b97;padding:10px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Muster anfordern<\/a>\n<\/div>\n<p style=\"font-size:13px;color:#6b7f82;margin-top:32px;border-top:1px solid #d8e8e7;padding-top:16px;\">\n<em>SeamlessBio \u00b7 Passau, Deutschland \u00b7 <a href=\"mailto:info@seamlessbio.de\">info@seamlessbio.de<\/a><\/em>\n<\/p>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quick Definition What is Disease State Serum?: Disease state serum is human serum collected from donors with a confirmed medical condition \u2014 such as HBV, HCV, HIV, rheumatoid arthritis, or metabolic diseases. It is used in IVD assay development for cross-reactivity testing, sensitivity at clinical decision limits, interference testing, and biomarker validation in real positive [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"class_list":["post-2988","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is Disease State Serum? \u2014 Definition &amp; IVD Use<\/title>\n<meta name=\"description\" content=\"What is disease state serum, what conditions are available, and how is it used for IVD assay development, cross-reactivity testing and biomarker validation?\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is Disease State Serum? \u2014 Definition &amp; IVD Use\" \/>\n<meta property=\"og:description\" content=\"What is disease state serum, what conditions are available, and how is it used for IVD assay development, cross-reactivity testing and biomarker validation?\" \/>\n<meta property=\"og:url\" content=\"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/\" \/>\n<meta property=\"og:site_name\" content=\"SeamlessBio\" \/>\n<meta property=\"article:modified_time\" content=\"2026-11-02T15:25:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png\" \/>\n\t<meta property=\"og:image:width\" content=\"973\" \/>\n\t<meta property=\"og:image:height\" content=\"288\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/\",\"name\":\"What is Disease State Serum? \u2014 Definition & IVD Use\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\"},\"datePublished\":\"2026-08-22T20:05:41+00:00\",\"dateModified\":\"2026-11-02T15:25:14+00:00\",\"description\":\"What is disease state serum, what conditions are available, and how is it used for IVD assay development, cross-reactivity testing and biomarker validation?\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/seamlessbio.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"What is Disease State Serum?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"name\":\"SeamlessBio\",\"description\":\"Human serum, plasma and hPL, single-use bioprocessing bags, serum-free media, animal sera and FBS. EU stock, lot reservation up to 36 months, no minimum order.\",\"publisher\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/seamlessbio.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":[\"Organization\",\"Place\",\"ProfessionalService\"],\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#organization\",\"name\":\"SeamlessBio\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"logo\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#local-main-organization-logo\"},\"image\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#local-main-organization-logo\"},\"alternateName\":\"Seamless Bio\",\"description\":\"SeamlessBio is a European supplier of biological raw materials for life science research, diagnostics and bioprocessing: human serum and plasma, human platelet lysate, FBS and animal sera, albumin, serum-free media, single-use bioprocessing bags and DMPK transporter vesicle kits.\",\"disambiguatingDescription\":\"Supplier of sera, human biomaterials and cell culture reagents based in Passau, Germany (seamlessbio.de), with Swiss supply via Seamless Bio GmbH (seamlessbio.ch).\",\"knowsAbout\":[\"Human serum\",\"Human plasma\",\"Human platelet lysate\",\"Fetal bovine serum\",\"Animal sera\",\"Human serum albumin\",\"Recombinant human serum albumin\",\"Serum-free cell culture media\",\"Single-use bioprocessing bags\",\"ABC transporter vesicle assays\"],\"areaServed\":[\"EU\",\"CH\",\"GB\"],\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/seamlessbio\\\/\",\"https:\\\/\\\/seamlessbio.ch\\\/\"],\"address\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#local-main-place-address\"},\"telephone\":[\"+49 (851) 37932226\"],\"contactPoint\":{\"@type\":\"ContactPoint\",\"telephone\":\"+49 (851) 37932226\",\"email\":\"info@seamlessbio.de\"},\"openingHoursSpecification\":[{\"@type\":\"OpeningHoursSpecification\",\"dayOfWeek\":[\"Monday\",\"Tuesday\",\"Wednesday\",\"Thursday\",\"Friday\"],\"opens\":\"09:00\",\"closes\":\"17:00\"},{\"@type\":\"OpeningHoursSpecification\",\"dayOfWeek\":[\"Saturday\",\"Sunday\"],\"opens\":\"00:00\",\"closes\":\"00:00\"}],\"email\":\"info@seamlessbio.de\"},{\"@type\":\"PostalAddress\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#local-main-place-address\",\"streetAddress\":\"Dr.-Ernst-Derra-Str. 4\",\"addressLocality\":\"Passau\",\"postalCode\":\"94036\",\"addressRegion\":\"Bavaria\",\"addressCountry\":\"DE\"},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-disease-state-serum\\\/#local-main-organization-logo\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/134428046-2.png\",\"contentUrl\":\"https:\\\/\\\/seamlessbio.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/134428046-2.png\",\"width\":973,\"height\":288,\"caption\":\"SeamlessBio\"}]}<\/script>\n<meta name=\"geo.placename\" content=\"Passau\" \/>\n<meta name=\"geo.region\" content=\"Deutschland\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Was ist Disease-State-Serum? \u2013 Definition &amp; IVD-Einsatz","description":"Was ist Disease-State-Serum, welche Krankheitsbilder sind verf\u00fcgbar und wie wird es in der IVD-Assayentwicklung, bei Kreuzreaktivit\u00e4tstests und der Biomarker-Validierung eingesetzt?","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/","og_locale":"de_DE","og_type":"article","og_title":"What is Disease State Serum? \u2014 Definition & IVD Use","og_description":"What is disease state serum, what conditions are available, and how is it used for IVD assay development, cross-reactivity testing and biomarker validation?","og_url":"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/","og_site_name":"SeamlessBio","article_modified_time":"2026-11-02T15:25:14+00:00","og_image":[{"width":973,"height":288,"url":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"2\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/","url":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/","name":"Was ist Disease-State-Serum? \u2013 Definition &amp; IVD-Einsatz","isPartOf":{"@id":"https:\/\/seamlessbio.de\/#website"},"datePublished":"2026-08-22T20:05:41+00:00","dateModified":"2026-11-02T15:25:14+00:00","description":"Was ist Disease-State-Serum, welche Krankheitsbilder sind verf\u00fcgbar und wie wird es in der IVD-Assayentwicklung, bei Kreuzreaktivit\u00e4tstests und der Biomarker-Validierung eingesetzt?","breadcrumb":{"@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/seamlessbio.de\/what-is-disease-state-serum\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Start","item":"https:\/\/seamlessbio.de\/"},{"@type":"ListItem","position":2,"name":"What is Disease State Serum?"}]},{"@type":"WebSite","@id":"https:\/\/seamlessbio.de\/#website","url":"https:\/\/seamlessbio.de\/","name":"SeamlessBio","description":"Humanserum, Plasma und hPL, Single-Use-Bioprozessbeutel, serumfreie Medien, Tierseren und FKS. EU-Lager, Chargenreservierung bis 36 Monate, ohne Mindestmenge.","publisher":{"@id":"https:\/\/seamlessbio.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/seamlessbio.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":["Organization","Place","ProfessionalService"],"@id":"https:\/\/seamlessbio.de\/#organization","name":"SeamlessBio","url":"https:\/\/seamlessbio.de\/","logo":{"@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#local-main-organization-logo"},"image":{"@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#local-main-organization-logo"},"alternateName":"Seamless Bio","description":"SeamlessBio ist ein europ\u00e4ischer Lieferant biologischer Rohstoffe f\u00fcr Life-Science-Forschung, Diagnostik und Bioprocessing: Humanserum und -plasma, humanes Thrombozytenlysat, FKS und Tierseren, Albumin, serumfreie Medien, Single-Use-Bioprozessbeutel und DMPK-Transporter-Vesikel-Kits.","disambiguatingDescription":"Supplier of sera, human biomaterials and cell culture reagents based in Passau, Germany (seamlessbio.de), with Swiss supply via Seamless Bio GmbH (seamlessbio.ch).","knowsAbout":["Human serum","Human plasma","Human platelet lysate","Fetal bovine serum","Animal sera","Human serum albumin","Recombinant human serum albumin","Serum-free cell culture media","Single-use bioprocessing bags","ABC transporter vesicle assays"],"areaServed":["EU","CH","GB"],"sameAs":["https:\/\/www.linkedin.com\/company\/seamlessbio\/","https:\/\/seamlessbio.ch\/"],"address":{"@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#local-main-place-address"},"telephone":["+49 (851) 37932226"],"contactPoint":{"@type":"ContactPoint","telephone":"+49 (851) 37932226","email":"info@seamlessbio.de"},"openingHoursSpecification":[{"@type":"OpeningHoursSpecification","dayOfWeek":["Monday","Tuesday","Wednesday","Thursday","Friday"],"opens":"09:00","closes":"17:00"},{"@type":"OpeningHoursSpecification","dayOfWeek":["Saturday","Sunday"],"opens":"00:00","closes":"00:00"}],"email":"info@seamlessbio.de"},{"@type":"PostalAddress","@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#local-main-place-address","streetAddress":"Dr.-Ernst-Derra-Str. 4","addressLocality":"Passau","postalCode":"94036","addressRegion":"Bavaria","addressCountry":"DE"},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/#local-main-organization-logo","url":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046-2.png","contentUrl":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046-2.png","width":973,"height":288,"caption":"SeamlessBio"}]},"geo.placename":"Passau","geo.region":"Deutschland"},"_links":{"self":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/2988","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/comments?post=2988"}],"version-history":[{"count":8,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/2988\/revisions"}],"predecessor-version":[{"id":10484,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/2988\/revisions\/10484"}],"wp:attachment":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/media?parent=2988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}