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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

FormatApplicationKey SpecificationProduct
Universal Negative SerumNegative 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 SerumLipemia 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 TreatedHormone-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 HIBlocking 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 PanelsPositive 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 →
Human PlasmaCoagulation 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 RequirementSeamlessBio 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

What is the difference between delipidated serum and standard serum for immunoassay development?
Delipidated human serum has triglycerides and LDL selectively removed by dextran sulfate-MgCl₂ precipitation — reducing lipid content to near-zero while preserving endogenous proteins, albumin, and immunoglobulins. This base is used in CLSI EP7 lipemia interference studies: the delipidated matrix is spiked with defined intralipid or triglyceride concentrations to test at what lipid level the assay signal deviates by more than 10% from the lipemia-free result. Standard serum cannot be used for this — it has variable baseline lipid content that confounds the interference calculation.
When is Double Charcoal Treated serum required?
Double Charcoal Treated serum is required when developing or validating immunoassays for endogenous small molecules — steroid hormones (oestradiol, testosterone, progesterone, cortisol), thyroid hormones (T3, T4, TSH), drugs of abuse, vitamins, and other small lipophilic analytes. Charcoal adsorption strips these endogenous molecules below assay detection limits, creating a hormone/drug-free serum matrix into which calibrators can be added at known concentrations for standard curve preparation. Without charcoal treatment, endogenous hormone background inflates the zero-calibrator signal and compresses the standard curve.
Are SeamlessBio human sera suitable for IVDR-compliant IVD kit production?
Yes — SeamlessBio human sera are sourced from EU Blood Directive-qualified donor centres and supplied with the documentation package required for IVDR technical files: CoA, Certificate of Origin (EU blood centre), viral screening panel results (HIV 1/2 NAT + serology, HBsAg, anti-HCV + HCV RNA, syphilis), and donor qualification confirmation. Batch reservation is available for extended IVD kit production runs requiring consistent lot specification across multiple kit batches.

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

Need a Lot Reservation or Test Sample?

Reserve your validated FBS or human serum lot — no prepayment.
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