Quick Definition
What is Disease State Serum?: Disease state serum is human serum collected from donors with a confirmed medical condition — 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.
How is disease state serum used in IVD development?
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.
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.
Key Facts
- Infectious disease: HIV-1/2 positive, HBsAg positive (HBV), anti-HCV positive, HCV RNA positive, syphilis reactive
- Autoimmune: Rheumatoid factor (RF) positive, ANA positive, anti-dsDNA, anti-CCP — used for interference testing
- Metabolic: lipemic (TG >1,000 mg/dL), icteric (bilirubin >20 mg/dL), haemolytic (Hb >500 mg/dL) — required for CLSI EP7
- Endocrine: Vitamin D deficient (<10 ng/mL), hypo/hyperthyroid — for TSH/T3/T4 assay development
- Supplied with informed consent documentation, confirmed diagnostic test results, standard infectious disease screening
- Required for EU IVDR 2017/746 and FDA 510(k) cross-reactivity and interference validation
Further Reading
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