{"id":3271,"date":"2026-08-27T21:18:40","date_gmt":"2026-08-27T20:18:40","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=3271"},"modified":"2026-08-27T21:52:33","modified_gmt":"2026-08-27T20:52:33","slug":"human-quality-controls-standard-materials","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/human-quality-controls-standard-materials\/","title":{"rendered":"Human IVD Quality Controls"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3271\" class=\"elementor elementor-3271\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f8b81ca e-con e-atomic-element e-flexbox-base e-e4c0c63 \" data-id=\"f8b81ca\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"f8b81ca\" data-e-type=\"e-flexbox\" data-id=\"f8b81ca\">\n    \t\t<div class=\"elementor-element elementor-element-5ca9290 elementor-widget elementor-widget-html\" data-id=\"5ca9290\" 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: human-quality-controls-standard-materials\nSEO Title: Human IVD Quality Controls & Standard Materials | SeamlessBio\nMeta Description: Human-origin quality controls for IVD assay development \u2014 autoimmunity, infectiology, endocrinology, gastroenterology, oncology and allergy. CE-certified controls available.\nFocus Keyword: human IVD quality controls standard materials\nMeta Robots: index, follow\n-->\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \"@type\": \"BreadcrumbList\",\n      \"itemListElement\": [\n        { \"@type\": \"ListItem\", \"position\": 1, \"name\": \"Home\", \"item\": \"https:\/\/seamlessbio.de\/\" },\n        { \"@type\": \"ListItem\", \"position\": 2, \"name\": \"Products\", \"item\": \"https:\/\/seamlessbio.de\/products\/\" },\n        { \"@type\": \"ListItem\", \"position\": 3, \"name\": \"Human Biomaterials & IVD\", \"item\": \"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\" },\n        { \"@type\": \"ListItem\", \"position\": 4, \"name\": \"Quality Controls & Standard Materials\", \"item\": \"https:\/\/seamlessbio.de\/human-quality-controls-standard-materials\/\" }\n      ]\n    },\n    {\n      \"@type\": \"Product\",\n      \"name\": \"Human IVD Quality Controls & Standard Materials\",\n      \"brand\": { \"@type\": \"Brand\", \"name\": \"SeamlessBio\" },\n      \"description\": \"Native human-origin quality controls for IQC, EQA and proficiency testing across autoimmunity, infectiology, endocrinology, gastroenterology, oncology and allergy. CE-certified controls for calprotectin and PSA available.\",\n      \"offers\": { \"@type\": \"Offer\", \"url\": \"https:\/\/seamlessbio.de\/contact\/\", \"availability\": \"https:\/\/schema.org\/InStock\", \"priceCurrency\": \"EUR\" }\n    },\n    {\n      \"@type\": \"FAQPage\",\n      \"mainEntity\": [\n        {\n          \"@type\": \"Question\",\n          \"name\": \"Are CE-certified controls available?\",\n          \"acceptedAnswer\": { \"@type\": \"Answer\", \"text\": \"Yes \u2014 CE-certified In.QualiCheck controls are available for calprotectin (faeces, 3 levels) and prostate-specific antigen PSA (serum, single level). Custom individual quality controls with CE-IVD marking can also be produced to your specification.\" }\n        },\n        {\n          \"@type\": \"Question\",\n          \"name\": \"Are the controls commutable with patient samples?\",\n          \"acceptedAnswer\": { \"@type\": \"Answer\", \"text\": \"The controls are produced from native human biomaterial with no additives \u2014 this maximises commutability with patient samples compared to reconstituted or spiked controls. Native human material behaves consistently across different assay platforms, making these controls suitable for multi-platform EQA programmes.\" }\n        }\n      ]\n    }\n  ]\n}\n<\/script>\n\n<section class=\"sb-hsm-page\">\n<div class=\"sb-hsm-container\">\n\n<nav class=\"sb-hsm-bc\">\n  <a href=\"https:\/\/seamlessbio.de\/\">Home<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/products\/\">Products<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\">Human Biomaterials &amp; IVD<\/a><span>\/<\/span>\n  <strong>Quality Controls &amp; Standard Materials<\/strong>\n<\/nav>\n\n<div class=\"sb-hsm-hero\">\n  <div class=\"sb-hsm-hero-text\">\n    <span class=\"sb-hsm-eyebrow\">Native Human Material \u00b7 CE-Certified Controls Available \u00b7 ISO 13485<\/span>\n    <h1>Human IVD Quality Controls &amp; Standard Materials<\/h1>\n    <p>Native human-origin quality controls for internal laboratory quality control (IQC), external quality assurance (EQA) and proficiency testing \u2014 produced from native human biomaterial with no additives, maximising commutability with patient samples across different assay platforms.<\/p>\n    <div class=\"sb-hsm-hero-tags\">\n      <span>Autoimmunity<\/span><span>Infectiology<\/span><span>Endocrinology<\/span>\n      <span>Gastroenterology<\/span><span>Oncology<\/span><span>Allergy<\/span><span>CE-Certified<\/span>\n    <\/div>\n    <div class=\"sb-hsm-hero-btns\">\n      <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-btn\">Request Quote<\/a>\n      <a href=\"mailto:info@seamlessbio.de?subject=IVD%20Quality%20Controls%20Quote\" class=\"sb-hsm-btn-outline\">info@seamlessbio.de<\/a>\n    <\/div>\n  <\/div>\n  <div class=\"sb-hsm-hero-image\">\n    <div class=\"sb-hsm-img-fallback\" style=\"display:flex;\">Quality Controls &amp; Standards<\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-facts\">\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">CE-IVD<\/span><span>CE-certified controls for calprotectin and PSA \u2014 In.QualiCheck range<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">Native<\/span><span>No additives \u2014 maximises commutability across platforms<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">Confirmed<\/span><span>All controls tested with CE-certified IVD test systems<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">Custom<\/span><span>Individual QC production to your specification available<\/span><\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>CE-Certified Controls \u2014 In.QualiCheck<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Control<\/th><th>Matrix<\/th><th>Levels<\/th><th>CE-IVD<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>Calprotectin Control (In.QualiCheck)<\/td><td>Faeces<\/td><td>Level 1, 2, 3<\/td><td>\u2705<\/td><\/tr>\n        <tr><td>Prostate Specific Antigen \u2014 PSA (In.QualiCheck)<\/td><td>Serum<\/td><td>Single level<\/td><td>\u2705<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Controls by Diagnostic Area<\/h2>\n  <div class=\"sb-hsm-app-grid\">\n    <div class=\"sb-hsm-app\">\n      <h3>Autoimmunity<\/h3>\n      <p>Anti-ENA, ANA, APS, autoimmune dermatosis, endocrinopathy, diabetes mellitus, celiac, hepatopathy, myasthenia gravis, paraneoplastic neuropathy, peripheral neuropathy, rheumatoid arthritis, vasculitis &amp; glomerulonephritis<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Infectiology<\/h3>\n      <p>CMV PCR, enterovirus faeces PCR, HAV Ab, HEV Ab, HHV-6 PCR, HPV 18 PCR, measles\/mumps\/rubella\/rabies PCR, rotavirus faeces PCR, VZV PCR<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Endocrinology<\/h3>\n      <p>Adrenal &amp; pituitary gland, aldosterone, bone metabolism, calcium metabolism, cortisol salivary, fertility hormones, hematopoietic growth factors, thyroid autoantibodies &amp; hormones, virilization<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Gastroenterology &amp; Special<\/h3>\n      <p>Calprotectin &amp; elastase faecal, H. pylori antigen faecal, haemoglobin-haptoglobin complex, occult blood faecal, CSF standard profile, urine standard profile<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Immunology<\/h3>\n      <p>Gammopathies, IgG subclasses, immunophenotyping (whole blood), interferon gamma release, CRP\/PCT\/SAA inflammatory markers<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Allergy &amp; Alcohol\/Drugs<\/h3>\n      <p>Inhalation, insects, nutrition allergy \u2014 CDT, EtG, PEth \u2014 antibiotics, cytostatics, cardiac glycosides, antiepileptics, immunosuppressants (EDTA plasma)<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-alt\">\n  <h2>Custom Individual Quality Controls<\/h2>\n  <div class=\"sb-hsm-two-col\">\n    <div class=\"sb-hsm-text\">\n      <h3>To Your Specification<\/h3>\n      <p>Individual quality controls produced to your detailed specification \u2014 for internal laboratory performance monitoring, proficiency testing, or as the basis for your own IVD quality control product. Specify analyte, target concentration range, matrix, volume, and stability requirements.<\/p>\n      <h3>CE-IVD Marking Available<\/h3>\n      <p>Production of CE-IVD certified controls to your specification is available \u2014 from the same ISO 13485 and ISO 9001 certified quality system. Contact us to discuss your project requirements and timelines.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-ref-box\">\n      <h3>Why native human material matters<\/h3>\n      <p>Controls produced from native human biomaterial with no additives behave consistently across different analytical platforms \u2014 unlike reconstituted lyophilised or spiked controls, which can show matrix effects that differ between immunoassay platforms. This makes native human QC materials the preferred choice for multi-platform EQA programmes and cross-platform validation studies.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Frequently Asked Questions<\/h2>\n  <div class=\"sb-hsm-faqs\">\n    <div class=\"sb-hsm-faq\">\n      <h3>Are the controls commutable across different analyser platforms?<\/h3>\n      <p>Native human material controls have excellent commutability because they behave like real patient samples. This is a key advantage over reconstituted or spiked controls, which can show platform-specific matrix effects. For multi-platform EQA and cross-platform validation, native human controls are the recommended format.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>What infectious disease screening is performed on control donors?<\/h3>\n      <p>All control donors are screened for HIV I\/II Ab, HBsAg and HCV Ab and confirmed negative\/non-reactive \u2014 unless the control is specifically designed to be positive for these markers. All testing is performed using CE-certified IVD test systems.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>Can controls be produced in larger volumes for multi-year programmes?<\/h3>\n      <p>Yes \u2014 large-volume production for multi-year programmes is available. Batch reservation with free storage up to two years ensures consistency across your programme duration. Contact us to discuss volume requirements and storage arrangements.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Related Products<\/h2>\n  <div class=\"sb-hsm-related\">\n    <a href=\"https:\/\/seamlessbio.de\/disease-state-serum-panels\/\" class=\"sb-hsm-rel\">\n      <h3>Disease State Serum Panels<\/h3>\n      <p>Confirmed-positive disease state materials for assay development and cross-reactivity testing.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/ivdr-class-d-sample-sets\/\" class=\"sb-hsm-rel\">\n      <h3>IVDR Class D Sample Sets<\/h3>\n      <p>HBV, HCV, HIV compliance panels per CTS 2009\/108\/EC.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/fertility-pregnancy-serum-materials\/\" class=\"sb-hsm-rel\">\n      <h3>Fertility &amp; Pregnancy Materials<\/h3>\n      <p>hCG, AMH, FSH, LH, trimester-specific pools.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\" class=\"sb-hsm-rel\">\n      <h3>Human Biomaterials &amp; IVD<\/h3>\n      <p>Full portfolio overview \u2014 all product categories.<\/p>\n    <\/a>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-cta\">\n  <h2>Request Quality Controls \u2014 Quote<\/h2>\n  <p>CE-certified In.QualiCheck controls or custom production to your specification \u2014 48-hour quote turnaround.<\/p>\n  <div class=\"sb-hsm-cta-btns\">\n    <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-btn-w\">Contact Us<\/a>\n    <a href=\"mailto:info@seamlessbio.de?subject=IVD%20Quality%20Controls%20Quote\" class=\"sb-hsm-btn-o\">info@seamlessbio.de<\/a>\n  <\/div>\n  <p class=\"sb-hsm-ruo\">For research use only unless stated otherwise.<\/p>\n<\/div>\n\n<\/div>\n<\/section>\n\n<style>\n.sb-hsm-page,.sb-hsm-page *,.sb-hsm-page *::before,.sb-hsm-page *::after{box-sizing:border-box}\n.sb-hsm-page{font-family:Arial,sans-serif;color:#1a1a1a;background:#fff;padding:60px 32px 90px}\n.sb-hsm-container{max-width:1200px;margin:0 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