{"id":1876,"date":"2026-06-27T12:48:11","date_gmt":"2026-06-27T11:48:11","guid":{"rendered":"http:\/\/seamlessbio.de\/?page_id=1876"},"modified":"2026-06-27T12:49:29","modified_gmt":"2026-06-27T11:49:29","slug":"human-serum-for-immunoassays","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/human-serum-for-immunoassays\/","title":{"rendered":"Application Human Serum for Immunoassay"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1876\" class=\"elementor elementor-1876\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0044f56 e-con e-atomic-element e-flexbox-base e-f6c5aac \" data-id=\"0044f56\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"0044f56\">\n    \t\t<div class=\"elementor-element elementor-element-ba7f8b1 elementor-widget elementor-widget-html\" data-id=\"ba7f8b1\" data-element_type=\"widget\" data-e-type=\"widget\" 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.rel-grid a:hover{border-color:#18b7b2;color:#139b97!important;}.sb-app .hub-back{text-align:center;padding:20px 0 0;border-top:1px solid rgba(24,183,178,.15);margin-bottom:16px;}.sb-app .hub-back a{color:#18b7b2;font-size:14px;font-weight:700;text-decoration:none;}.sb-app .cta{padding:54px 34px;border-radius:30px;background:#f7fbfb;border:1px solid rgba(24,183,178,.18);text-align:center;}.sb-app .cta h2{margin:0 0 12px;color:#111;font-size:28px;font-weight:900;}.sb-app .cta p{max-width:760px;margin:0 auto 26px;color:#555;font-size:15px;line-height:1.65;}.sb-app .ctabtns{display:flex;flex-wrap:wrap;gap:14px;justify-content:center;}.sb-app .ctab1,.sb-app .ctab2{display:inline-flex;align-items:center;justify-content:center;min-height:46px;padding:0 28px;border-radius:999px;font-size:13px;font-weight:900;text-transform:uppercase;text-decoration:none!important;transition:all .25s;}.sb-app .ctab1{background:#18b7b2;color:#fff!important;}.sb-app .ctab1:hover{background:#139b97;transform:translateY(-2px);}.sb-app .ctab2{background:transparent;border:2px solid #18b7b2;color:#18b7b2!important;}.sb-app .ctab2:hover{background:#18b7b2;color:#fff!important;transform:translateY(-2px);}@media(max-width:700px){.sb-app{padding:50px 16px 70px;}.sb-app .hero{padding:40px 24px;border-radius:24px;}.sb-app .hero h1{font-size:25px;}.sb-app .hbtns,.sb-app .ctabtns{flex-direction:column;}.sb-app .btn1,.sb-app .btn2,.sb-app .ctab1,.sb-app .ctab2{width:100%;}.sb-app .sec,.sb-app .faq{padding:20px;}.sb-app .cta{padding:36px 20px;}.sb-app .rel-grid{grid-template-columns:1fr;}}<\/style>\n<div class=\"wrap\">\n  <div class=\"bc\"><a href=\"http:\/\/seamlessbio.de\/\">Home<\/a><span>\/<\/span><a href=\"https:\/\/www.seamlessbio.de\/applications\/\">Applications<\/a><span>\/<\/span><strong>Human Serum for Immunoassays<\/strong><\/div>\n  <div class=\"hero\">\n    <span class=\"ey\">SeamlessBio \u2014 IVD \u00b7 Diagnostics \u00b7 IVDR \u00b7 EU Donors<\/span>\n    <h1>Human Serum for Immunoassays &amp; IVD \u2014 Diagnostics Supply Guide<\/h1>\n    <p class=\"sub\">Immunoassay development and IVD manufacturing require human serum formats that are not available from standard research suppliers \u2014 delipidated serum for lipemia interference studies, double charcoal-treated serum for hormone assays, Universal Negative serum for assay calibration, and auto-immune disease panel sera for diagnostics validation. SeamlessBio supplies all IVD formats with EU donor documentation aligned to IVDR 2017\/746.<\/p>\n    <div class=\"hbtns\"><a href=\"mailto:info@seamlessbio.de\" class=\"btn1\">Contact Us<\/a><a href=\"https:\/\/shop.seamlessbio.de\" class=\"btn2\">View in Shop<\/a><\/div>\n  <\/div>\n\n  <div class=\"sec\">\n    <h2>Human Serum Formats for IVD &amp; Immunoassay Applications<\/h2>\n    <div class=\"tw\">\n      <table>\n        <thead><tr><th>Format<\/th><th>Application<\/th><th>Key Specification<\/th><th>Product<\/th><\/tr><\/thead>\n        <tbody>\n          <tr><td><strong>Universal Negative Serum<\/strong><\/td><td>Negative calibrator matrix in immunoassays. Zero-standard preparation. Assay background baseline.<\/td><td>Tested negative for HIV, HBV, HCV, syphilis. Low background across standard analyte panels.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\">Universal Negative \u2192<\/a><\/td><\/tr>\n          <tr><td><strong>Delipidated Human Serum<\/strong><\/td><td>Lipemia interference studies per CLSI EP7. Interference testing for lipid-sensitive assays.<\/td><td>Triglycerides and LDL selectively removed by dextran sulfate precipitation. Endogenous proteins preserved. Used at defined triglyceride spike concentrations for EP7 testing.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/human-serum-delipidated\">Delipidated Serum \u2192<\/a><\/td><\/tr>\n          <tr><td><strong>Double Charcoal Treated<\/strong><\/td><td>Hormone-free matrix for steroid, thyroid, and small molecule immunoassays. Radioimmunoassay (RIA) diluent.<\/td><td>Charcoal strips endogenous hormones, drugs, and small molecules. Total protein and albumin preserved. Hormone concentrations below assay detection limits.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\">Double Charcoal Treated \u2192<\/a><\/td><\/tr>\n          <tr><td><strong>Human Serum AB HI<\/strong><\/td><td>Blocking serum, secondary antibody controls, non-specific binding reduction.<\/td><td>AB type eliminates anti-A\/B. Heat inactivated \u2014 no complement interference. EU donors.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/human-serum-type-ab-male\">Human Serum AB HI \u2192<\/a><\/td><\/tr>\n          <tr><td><strong>Auto-Immune Disease Panels<\/strong><\/td><td>Positive controls for auto-immune diagnostics. ANA, anti-dsDNA, ANCAs, rheumatoid factor, anti-CCP.<\/td><td>Characterised for specific autoantibody titre. Certificate of characterisation per panel. Used as positive controls in IVD kit development and lot release testing.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/auto-immune-diseases-for-controls\">Auto-Immune Panels \u2192<\/a><\/td><\/tr>\n          <tr><td><strong>Human Plasma<\/strong><\/td><td>Coagulation factor assays, fibrinogen immunoassays, platelet-derived analyte studies.<\/td><td>EDTA or citrate anticoagulated. Platelet-poor or platelet-rich available. EU donors, viral screened.<\/td><td><a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/human-plasma\">Human Plasma \u2192<\/a><\/td><\/tr>\n        <\/tbody>\n      <\/table>\n    <\/div>\n  <\/div>\n\n  <div class=\"sec\">\n    <h2>IVDR 2017\/746 \u2014 What Documentation You Need<\/h2>\n    <p>Under EU IVDR 2017\/746, human-derived materials used in IVD development and manufacturing must be documented as qualified ancillary materials. Key requirements include donor qualification, viral screening records, and traceability to EU blood centres. SeamlessBio human sera are sourced from EU-qualified blood donor centres and supplied with documentation aligned to IVDR technical file requirements.<\/p>\n    <div class=\"tw\">\n      <table>\n        <thead><tr><th>IVDR Requirement<\/th><th>SeamlessBio Documentation<\/th><\/tr><\/thead>\n        <tbody>\n          <tr><td>Donor qualification (EU Blood Directive 2002\/98\/EC)<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 EU-qualified donor centres \u2014 confirmed per lot<\/td><\/tr>\n          <tr><td>Viral screening panel (HIV, HBV, HCV, syphilis)<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 Per lot \u2014 NAT + serology results<\/td><\/tr>\n          <tr><td>Traceability to blood centre<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 Certificate of Origin \u2014 EU blood centre<\/td><\/tr>\n          <tr><td>Certificate of Analysis<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 Per lot \u2014 all analytes and format specifications<\/td><\/tr>\n          <tr><td>Lot-to-lot consistency data<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 Overlapping lot data on request<\/td><\/tr>\n          <tr><td>Batch reservation for IVD kit production<\/td><td class=\"ok\" style=\"color:#18b7b2;font-weight:700;\">\u2713 Extended reservation \u2014 per kit production campaign<\/td><\/tr>\n        <\/tbody>\n      <\/table>\n    <\/div>\n  <\/div>\n\n  <div class=\"faq\">\n    <h2>Frequently Asked Questions<\/h2>\n    <div class=\"faq-item\"><div class=\"faq-q\">What is the difference between delipidated serum and standard serum for immunoassay development?<\/div><div class=\"faq-a\">Delipidated human serum has triglycerides and LDL selectively removed by dextran sulfate-MgCl\u2082 precipitation \u2014 reducing lipid content to near-zero while preserving endogenous proteins, albumin, and immunoglobulins. This base is used in CLSI EP7 lipemia interference studies: the delipidated matrix is spiked with defined intralipid or triglyceride concentrations to test at what lipid level the assay signal deviates by more than 10% from the lipemia-free result. Standard serum cannot be used for this \u2014 it has variable baseline lipid content that confounds the interference calculation.<\/div><\/div>\n    <div class=\"faq-item\"><div class=\"faq-q\">When is Double Charcoal Treated serum required?<\/div><div class=\"faq-a\">Double Charcoal Treated serum is required when developing or validating immunoassays for endogenous small molecules \u2014 steroid hormones (oestradiol, testosterone, progesterone, cortisol), thyroid hormones (T3, T4, TSH), drugs of abuse, vitamins, and other small lipophilic analytes. Charcoal adsorption strips these endogenous molecules below assay detection limits, creating a hormone\/drug-free serum matrix into which calibrators can be added at known concentrations for standard curve preparation. Without charcoal treatment, endogenous hormone background inflates the zero-calibrator signal and compresses the standard curve.<\/div><\/div>\n    <div class=\"faq-item\"><div class=\"faq-q\">Are SeamlessBio human sera suitable for IVDR-compliant IVD kit production?<\/div><div class=\"faq-a\">Yes \u2014 SeamlessBio human sera are sourced from EU Blood Directive-qualified donor centres and supplied with the documentation package required for IVDR technical files: CoA, Certificate of Origin (EU blood centre), viral screening panel results (HIV 1\/2 NAT + serology, HBsAg, anti-HCV + HCV RNA, syphilis), and donor qualification confirmation. Batch reservation is available for extended IVD kit production runs requiring consistent lot specification across multiple kit batches.<\/div><\/div>\n  <\/div>\n\n  <div class=\"related\"><h3>Related Applications &amp; Products<\/h3><div class=\"rel-grid\">\n    <a href=\"https:\/\/www.seamlessbio.de\/applications\/switching-human-serum-supplier\">\u2192 Switching Human Serum Supplier Guide<\/a>\n    <a href=\"https:\/\/www.seamlessbio.de\/applications\/pbmc-immunology\">\u2192 PBMC &amp; Immunology Assay Guide<\/a>\n    <a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/human-serum-delipidated\">\u2192 Human Serum Delipidated<\/a>\n    <a href=\"https:\/\/www.seamlessbio.de\/products\/human-sera-plasma-and-more\/auto-immune-diseases-for-controls\">\u2192 Auto-Immune Disease Panels<\/a>\n    <a href=\"https:\/\/www.seamlessbio.de\/compare\/hsa-rhsa-grades-comparison\">\u2192 HSA vs rHSA Comparison<\/a>\n    <a href=\"https:\/\/www.seamlessbio.de\/products\/albumin-proteins\/human-serum-albumin-hsa\">\u2192 Human Serum Albumin (HSA)<\/a>\n  <\/div><\/div>\n  <div class=\"hub-back\"><a href=\"https:\/\/www.seamlessbio.de\/applications\/\">\u2190 All Application Guides Overview<\/a><\/div>\n  <div class=\"cta\"><h2>Request IVD Human Serum Samples &amp; IVDR Documentation<\/h2><p>Free test samples of all IVD human serum formats. Full IVDR-aligned documentation per lot. Batch reservation for IVD kit production campaigns.<br>Email: info@seamlessbio.de | +49 851 37932226<\/p>\n  <div class=\"ctabtns\"><a href=\"mailto:info@seamlessbio.de\" class=\"ctab1\">Contact Us<\/a><a href=\"https:\/\/shop.seamlessbio.de\" class=\"ctab2\">View in Shop<\/a><\/div><\/div>\n<\/div>\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \"@type\": \"FAQPage\",\n      \"@id\": \"https:\/\/www.seamlessbio.de\/applications\/human-serum-for-immunoassays#faqpage\",\n      \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is the difference between delipidated serum and standard serum for immunoassay development?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Delipidated human serum has triglycerides and LDL selectively removed by dextran sulfate-MgCl\u2082 precipitation \u2014 reducing lipid content to near-zero while preserving endogenous proteins, albumin, and immunoglobulins. 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IVD \u2014 Diagnostics Supply Guide Immunoassay development and IVD manufacturing require [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_eb_attr":"","footnotes":""},"class_list":["post-1876","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Application Human Serum for Immunoassay - SeamlessBio<\/title>\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\/human-serum-for-immunoassays\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Application Human Serum for Immunoassay - SeamlessBio\" \/>\n<meta property=\"og:description\" content=\"Home\/Applications\/Human Serum for Immunoassays SeamlessBio \u2014 IVD \u00b7 Diagnostics \u00b7 IVDR \u00b7 EU Donors Human Serum for Immunoassays &amp; 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