{"id":2988,"date":"2026-08-22T21:05:41","date_gmt":"2026-08-22T20:05:41","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=2988"},"modified":"2026-08-23T00:35:57","modified_gmt":"2026-08-22T23:35:57","slug":"what-is-disease-state-serum","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/what-is-disease-state-serum\/","title":{"rendered":"What is Disease State Serum?"},"content":{"rendered":"
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Quick Definition<\/p>\n

What is Disease State Serum?:<\/strong> 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 patient matrices.<\/p>\n<\/div>\n

How is disease state serum used in IVD development?<\/h2>\n

IVD regulatory submissions (EU IVDR, FDA 510(k)) require demonstration that the assay does not produce false positives in serum from conditions likely to co-exist in the tested population. For an HIV antibody test you must show no cross-reactivity with RF-positive, ANA-positive, HBV-positive, and malaria-positive serum. Disease state serum panels provide these challenge samples.<\/p>\n

Interference testing (CLSI EP7) requires lipemic, icteric, and haemolytic serum at defined concentrations to demonstrate that common sample quality variations do not affect assay accuracy beyond defined limits.<\/p>\n

Key Facts<\/h2>\n