{"id":3349,"date":"2026-08-31T15:19:26","date_gmt":"2026-08-31T14:19:26","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?p=3349"},"modified":"2026-10-20T10:53:24","modified_gmt":"2026-10-20T09:53:24","slug":"ivdr-class-d-sample-sets-what-you-need","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets-what-you-need\/","title":{"rendered":"IVDR-Probensets der Klasse D"},"content":{"rendered":"<p><!--\nWORDPRESS BLOG POST\nSlug: ivdr-class-d-sample-sets-what-you-need\nSEO Title: IVDR Class D Sample Sets \u2014 What You Actually Need | SeamlessBio\nMeta Description: A practical breakdown of which sample sets are required for HBV, HCV and HIV Class D IVD submissions under EU Regulation 2017\/746 and CTS 2009\/108\/EC.\nFocus Keyword: IVDR Class D sample sets HBV HCV HIV\nCategory: IVD Development\nTags: IVDR, IVD, disease state serum, human biomaterials, diagnostics\n--><br \/>\n<!-- \nWORDPRESS BLOG POST \u2014 PASTE INTO GUTENBERG\nCategory: IVD Development\nAdd featured image\nInternal links already included in content\n--><\/p>\n<style>\n.sb-blog-post{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,sans-serif;max-width:780px;margin:0 auto;padding:0 0 60px;color:#202020;line-height:1.75}\n.sb-blog-post .sb-lede{font-size:18px;font-weight:500;color:#3a4a50;border-left:4px solid #18b7b2;padding-left:20px;margin:0 0 32px;line-height:1.65}\n.sb-blog-post h2{font-size:24px;font-weight:800;margin:44px 0 14px;color:#111;padding-bottom:10px;border-bottom:2px solid #e2eceb}\n.sb-blog-post h3{font-size:18px;font-weight:700;margin:32px 0 10px;color:#18b7b2}\n.sb-blog-post p{margin:0 0 18px}\n.sb-blog-post ul,.sb-blog-post ol{margin:0 0 18px;padding-left:24px}\n.sb-blog-post li{margin-bottom:8px}\n.sb-blog-post table{width:100%;border-collapse:collapse;font-size:14px;margin:20px 0 28px;overflow-x:auto;display:block}\n.sb-blog-post th{background:#18b7b2;color:#fff;text-align:left;padding:10px 14px;font-weight:700;white-space:nowrap}\n.sb-blog-post td{padding:10px 14px;border-bottom:1px solid #e2eceb;vertical-align:top}\n.sb-blog-post tr:last-child td{border-bottom:none}\n.sb-blog-post td:first-child{font-weight:600;color:#111}\n.sb-blog-post a{color:#18b7b2;text-decoration:none;font-weight:600}\n.sb-blog-post a:hover{text-decoration:underline}\n.sb-blog-post strong{color:#111}\n<\/style>\n<div class=\"sb-blog-post\">\n<p class=\"sb-lede\">Wenn Sie eine CE-Kennzeichnung f\u00fcr ein IVD der Klasse D vorbereiten \u2013 einen HIV-, HBV- oder HCV-Test \u2013, stellen Sie schnell fest, dass die Gemeinsamen Technischen Spezifikationen (GTS 2009\/108\/EG) nicht nur festlegen, welche Leistung Sie nachweisen m\u00fcssen, sondern auch genau, mit welchen Proben. Dieser Beitrag schl\u00fcsselt die Anforderungen nach Anhang und Tabelle auf, damit Sie wissen, was Sie vor Studienbeginn beschaffen m\u00fcssen.<\/p>\n<h2>Warum Klasse D anders ist<\/h2>\n<p>IVDR-Klasse D umfasst die In-vitro-Diagnostika mit dem h\u00f6chsten Risiko \u2013 Produkte zum Nachweis lebensbedrohlicher \u00fcbertragbarer Erreger in Blut, Blutbestandteilen, Zellen, Geweben oder Organen zur Transfusion oder Transplantation, bei denen ein falsch-negatives Ergebnis ein hohes individuelles oder \u00f6ffentliches Gesundheitsrisiko darstellt. Praktisch bedeutet das: HIV-1\/2, HBV (HBsAg, Anti-HBc, Anti-HBs, DNA), HCV (Antik\u00f6rper, RNA), HTLV-I\/II und Treponema pallidum.<\/p>\n<p>Anders als bei Produkten der Klassen B und C ist bei Klasse D die Beteiligung einer Benannten Stelle an der Konformit\u00e4tsbewertung verpflichtend \u2013 ebenso die Chargenfreigabepr\u00fcfung durch ein nationales Referenzlabor (OMCL), bevor jede Produktionscharge in Verkehr gebracht wird. Die Leistungsdaten m\u00fcssen gegen die konkreten Anforderungen der GTS erhoben werden, nicht gegen irgendeine verf\u00fcgbare Probensammlung.<\/p>\n<h2>Die GTS \u2013 was sie konkret festlegen<\/h2>\n<p>Die Gemeinsamen Technischen Spezifikationen (Entscheidung 2009\/108\/EG der Kommission, in IVDR Anhang IX referenziert) definieren Mindestanforderungen an die Leistung von IVD der Klasse D. Jeder Anhang behandelt eine bestimmte Erregergruppe und enth\u00e4lt mehrere Tabellen f\u00fcr unterschiedliche Studientypen. Entscheidend: Jede Tabelle legt nicht nur die Probenzahl fest, sondern auch die genaue Zusammensetzung \u2013 und \u201enatives humanes Biomaterial ohne Zus\u00e4tze\u201c ist durchg\u00e4ngig die implizite Anforderung.<\/p>\n<h2>HBV \u2013 was Sie brauchen (Anhang VI)<\/h2>\n<p>Hepatitis B ist die komplexeste GTS-Panelanforderung, weil sie mehrere Marker (HBsAg, Anti-HBc, Anti-HBs, HBV-DNA) und mehrere Studientypen umfasst.<\/p>\n<table>\n<thead>\n<tr>\n<th>Studientyp<\/th>\n<th>GTS-Referenz<\/th>\n<th>Erforderliche Proben<\/th>\n<th>Anmerkungen<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 umfassend<\/td>\n<td>Anhang VI, Tabelle 1<\/td>\n<td>400 positive, davon 25 tagesfrisch<\/td>\n<td>Am anspruchsvollsten \u2013 Frischproben erfordern Vorabkoordination<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 Standard<\/td>\n<td>Anhang VI, Tabelle 2<\/td>\n<td>400 Anti-HBc- + HBsAg-positive<\/td>\n<td>F\u00fcr Kombinations-Markerassays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 nur HBsAg<\/td>\n<td>Anhang VI, Tabelle 3<\/td>\n<td>300 HBsAg-positive<\/td>\n<td>F\u00fcr HBsAg-spezifische Assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 Anti-HBs<\/td>\n<td>Anhang VI, Tabelle 4<\/td>\n<td>100\u2013200 positive + geimpfte Spender<\/td>\n<td>Geimpfte Spender erfordern ein separates Panel<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 HBV-DNA<\/td>\n<td>Anhang VI, Tabelle 5<\/td>\n<td>100 DNA-positive<\/td>\n<td>Nur molekulare Assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Spezifit\u00e4t<\/td>\n<td>Anhang VI, Tabellen 1\u20135<\/td>\n<td>200\u20135.000 Blutspender + 200 Krankenhauspatienten<\/td>\n<td>Unselektierte Blutspender \u2013 zuf\u00e4llige Bev\u00f6lkerungsstichprobe<\/td>\n<\/tr>\n<tr>\n<td>Validierung von Selbsttests<\/td>\n<td>Anhang VI, Tabelle 6<\/td>\n<td>200\u2013400 Laienanwender<\/td>\n<td>Nur f\u00fcr Produkte zur Eigenanwendung (Heimtests)<\/td>\n<\/tr>\n<tr>\n<td>Matrix\u00e4quivalenz<\/td>\n<td>Anhang I<\/td>\n<td>25 positive + 25 negative pro Matrix<\/td>\n<td>Erforderlich, wenn das Produkt mehrere Probenarten beansprucht<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>HCV \u2013 was Sie brauchen (Anhang V)<\/h2>\n<table>\n<thead>\n<tr>\n<th>Studientyp<\/th>\n<th>GTS-Referenz<\/th>\n<th>Erforderliche Proben<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 umfassend<\/td>\n<td>Anhang V, Tabelle 1<\/td>\n<td>400 HCV-positive, davon 25 tagesfrisch<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 Standard<\/td>\n<td>Anhang V, Tabelle 2<\/td>\n<td>400 HCV-Antik\u00f6rper-positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 reduziert<\/td>\n<td>Anhang V, Tabelle 3<\/td>\n<td>300 HCV-Antik\u00f6rper-positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 minimal<\/td>\n<td>Anhang V, Tabelle 5<\/td>\n<td>100 HCV-positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Spezifit\u00e4t<\/td>\n<td>Anhang V, Tabellen 1\u20135<\/td>\n<td>200\u20135.000 Blutspender<\/td>\n<\/tr>\n<tr>\n<td>Validierung von Selbsttests<\/td>\n<td>Anhang V, Tabelle 6<\/td>\n<td>200\u2013400 Laienanwender<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>HIV \u2013 was Sie brauchen (Anhang III)<\/h2>\n<table>\n<thead>\n<tr>\n<th>Studientyp<\/th>\n<th>GTS-Referenz<\/th>\n<th>Erforderliche Proben<\/th>\n<th>Anmerkungen<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 umfassend<\/td>\n<td>Anhang III, Tabelle 1<\/td>\n<td>400 HIV-1- + 100 HIV-2-positive<\/td>\n<td>Beide Subtypen erforderlich<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 Standard<\/td>\n<td>Anhang III, Tabelle 2<\/td>\n<td>400 HIV-1-positive<\/td>\n<td>Auf HIV-1 ausgerichtete Assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 HIV-1-Ag<\/td>\n<td>Anhang III, Tabelle 4<\/td>\n<td>50 HIV-1-Antigen-positive<\/td>\n<td>F\u00fcr kombinierte Ag\/Ak-Assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 reduziert<\/td>\n<td>Anhang III, Tabelle 3<\/td>\n<td>200 HIV-1-positive<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Sensitivit\u00e4t \u2013 minimal<\/td>\n<td>Anhang III, Tabelle 5<\/td>\n<td>100 HIV-1- + 100 HIV-2-positive<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Diagnostische Spezifit\u00e4t<\/td>\n<td>Anhang III, Tabellen 1\u20135<\/td>\n<td>200\u20135.000 Blutspender<\/td>\n<td>Unselektiert + Krankenhauspatienten<\/td>\n<\/tr>\n<tr>\n<td>Validierung von Selbsttests<\/td>\n<td>Anhang III, Tabelle 6<\/td>\n<td>200\u2013400 Laienanwender<\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Kreuzreaktivit\u00e4t und Interferenz \u2013 was zus\u00e4tzlich zu den Sensitivit\u00e4tspanels gefordert ist<\/h2>\n<p>Die GTS legen nicht nur Sensitivit\u00e4ts- und Spezifit\u00e4tspanels fest. F\u00fcr eine vollst\u00e4ndige Klasse-D-Einreichung brauchen Sie au\u00dferdem Interferenz- und Kreuzreaktivit\u00e4tsdaten, die zeigen, dass das Produkt in Gegenwart folgender Faktoren keine falsch-positiven Ergebnisse liefert:<\/p>\n<ul>\n<li><strong>Allgemeines Interferenzpanel:<\/strong> 16 Standard-St\u00f6rsubstanzen \u2013 typischerweise Rheumafaktor, antinukle\u00e4re Antik\u00f6rper, lip\u00e4misches, ikterisches und h\u00e4molytisches Serum, polyklonale Hypergammaglobulin\u00e4mie, Schwangerschaftsserum<\/li>\n<li><strong>Impfpanel:<\/strong> gegen h\u00e4ufige Erreger geimpfte Spender \u2013 Hepatitis-B-Impfung, Influenza, MMR \u2013, um eine Kreuzreaktivit\u00e4t durch Impfungen auszuschlie\u00dfen<\/li>\n<li><strong>Kreuzreagierende Erkrankungen:<\/strong> HIV-positive Spender f\u00fcr HBV-Assays und umgekehrt; positiv f\u00fcr Malaria, Syphilis, Toxoplasma, CMV, EBV \u2013 je nach Zielpopulation<\/li>\n<li><strong>Schwangere Spenderinnen:<\/strong> 100\u2013200 Schwangere f\u00fcr Assays, die im Schwangerschaftsscreening eingesetzt werden<\/li>\n<\/ul>\n<h2>Die drei h\u00e4ufigsten Fehler bei der Beschaffung von Klasse-D-Panels<\/h2>\n<p><strong>1. Gespiktes oder verd\u00fcnntes Positivmaterial statt nativer Spender beschaffen.<\/strong> Die GTS verlangen implizit natives humanes Biomaterial \u2013 echte Patienten mit best\u00e4tigt positiven Befunden, kein Serum gesunder Spender, das mit rekombinantem Antigen versetzt wurde, und keine verd\u00fcnnten hochpositiven Proben. Benannte Stellen pr\u00fcfen die Probendokumentation genau und lehnen gespiktes Material f\u00fcr Sensitivit\u00e4tspanels ab.<\/p>\n<p><strong>2. Die Anforderung an das Spezifit\u00e4tspanel untersch\u00e4tzen.<\/strong> F\u00fcnftausend unselektierte Blutspender sind eine gro\u00dfe logistische Herausforderung. Viele Hersteller untersch\u00e4tzen die Vorlaufzeit f\u00fcr gro\u00dfe Spezifit\u00e4tspanels \u2013 realistisch ist eine Planung 8\u201312 Wochen im Voraus.<\/p>\n<p><strong>3. Die Anforderung an Frischproben \u00fcbersehen.<\/strong> Die Tabelle-1-Panels f\u00fcr HBV, HCV und HIV erfordern 25 tagesfrische Proben, die innerhalb weniger Stunden nach der Spende gewonnen und verarbeitet werden. Daf\u00fcr braucht es eine feste Vereinbarung mit einem Entnahmezentrum \u2013 aus einer gefrorenen Biobank lassen sie sich nicht beschaffen. Planen Sie dies so fr\u00fch wie m\u00f6glich in Ihrem Studienzeitplan ein.<\/p>\n<h2>N\u00e4chste Schritte<\/h2>\n<p>Der schnellste Weg zu einem vollst\u00e4ndigen Klasse-D-Panelpaket ist die Zusammenarbeit mit einem Lieferanten, der bereits GTS-referenzierte Panels zusammengestellt hat und die Besonderheiten jeder Tabelle kennt \u2013 nicht nur die Gesamtprobenzahl.<\/p>\n<p>SeamlessBio liefert IVDR-Probensets der Klasse D f\u00fcr HBV, HCV und HIV \u2013 referenziert auf den jeweiligen GTS-Anhang und die Tabellennummer, mit vollst\u00e4ndigen Ethikvotum-Unterlagen, Ergebnissen des Spenderscreenings und IVDR-Dokumentationspaket auf Anfrage. Panels sind ab Lager und als Sonderanfertigung erh\u00e4ltlich.<\/p>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets\/\">IVDR-Probensets der Klasse D ansehen \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/disease-state-serum-patientenseren\/\">Kreuzreaktivit\u00e4ts- &amp; Interferenzpanels \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-ivdr-class-d\/\">Was ist IVDR-Klasse D? \u2013 Definition \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">Angebot anfordern \u2192<\/a><\/li>\n<\/ul>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>If you are preparing a CE marking submission for a Class D IVD \u2014 an HIV, HBV or HCV diagnostic \u2014 you will quickly find that the Common Technical Specifications (CTS 2009\/108\/EC) define not just what performance you need to demonstrate, but exactly which samples you need to demonstrate it with. This post breaks down [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"categories":[47],"tags":[],"class_list":["post-3349","post","type-post","status-publish","format-standard","hentry","category-ivd-development"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVDR Class D Sample Sets \u2014 What You Actually Need<\/title>\n<meta name=\"description\" content=\"A practical breakdown of which sample sets are required for HBV, HCV and HIV Class D IVD submissions under EU Regulation 2017\/746 and CTS 2009\/108\/EC.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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