Human Serum for Immunoassays & IVD — Diagnostics Supply Guide
Immunoassay development and IVD manufacturing require human serum formats that are not available from standard research suppliers — 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.
Human Serum Formats for IVD & Immunoassay Applications
| Format | Anwendung | Key Specification | Product |
|---|---|---|---|
| Universal Negative Serum | Negative calibrator matrix in immunoassays. Zero-standard preparation. Assay background baseline. | Tested negative for HIV, HBV, HCV, syphilis. Low background across standard analyte panels. | Universal Negative → |
| Delipidated Human Serum | Lipemia interference studies per CLSI EP7. Interference testing for lipid-sensitive assays. | Triglycerides and LDL selectively removed by dextran sulfate precipitation. Endogenous proteins preserved. Used at defined triglyceride spike concentrations for EP7 testing. | Delipidated Serum → |
| Double Charcoal Treated | Hormone-free matrix for steroid, thyroid, and small molecule immunoassays. Radioimmunoassay (RIA) diluent. | Charcoal strips endogenous hormones, drugs, and small molecules. Total protein and albumin preserved. Hormone concentrations below assay detection limits. | Double Charcoal Treated → |
| Human Serum AB HI | Blocking serum, secondary antibody controls, non-specific binding reduction. | AB type eliminates anti-A/B. Heat inactivated — no complement interference. EU donors. | Human Serum AB HI → |
| Auto-Immune Disease Panels | Positive controls for auto-immune diagnostics. ANA, anti-dsDNA, ANCAs, rheumatoid factor, anti-CCP. | Characterised for specific autoantibody titre. Certificate of characterisation per panel. Used as positive controls in IVD kit development and lot release testing. | Auto-Immune Panels → |
| Humanplasma | Coagulation factor assays, fibrinogen immunoassays, platelet-derived analyte studies. | EDTA or citrate anticoagulated. Platelet-poor or platelet-rich available. EU donors, viral screened. | Human Plasma → |
IVDR 2017/746 — What Documentation You Need
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.
| IVDR Requirement | SeamlessBio Documentation |
|---|---|
| Donor qualification (EU Blood Directive 2002/98/EC) | ✓ EU-qualified donor centres — confirmed per lot |
| Viral screening panel (HIV, HBV, HCV, syphilis) | ✓ Per lot — NAT + serology results |
| Traceability to blood centre | ✓ Certificate of Origin — EU blood centre |
| Certificate of Analysis | ✓ Per lot — all analytes and format specifications |
| Lot-to-lot consistency data | ✓ Overlapping lot data on request |
| Batch reservation for IVD kit production | ✓ Extended reservation — per kit production campaign |
Frequently Asked Questions
Related Applications & Products
Request IVD Human Serum Samples & IVDR Documentation
Free test samples of all IVD human serum formats. Full IVDR-aligned documentation per lot. Batch reservation for IVD kit production campaigns.
Email: info@seamlessbio.de | +49 851 37932226
