Entfettetes Humanserum
Human serum with lipoproteins and lipids removed — the standard matrix for IVD calibrator and control development, lipemia interference studies (CLSI EP7), and steroid/lipid research requiring a defined, optically clear serum base. Available in three variants: standard delipidated, delipidated plus ultra-low IgG, and double charcoal treated for complete steroid depletion.
Delipidated vs. Charcoal Stripped — The Critical Distinction
This is the question most IVD development teams ask first. The answer determines whether your calibrator matrix interference study is scientifically valid.
Delipidated serum has lipids and lipoproteins removed using physical extraction methods. Hormones, steroids and other small molecules are largely retained. The result is an optically clear matrix — visually equivalent to a low-triglyceride sample — while preserving the protein and hormone composition of normal serum.
Charcoal stripped serum uses activated charcoal to adsorb small hydrophobic molecules — including lipids, but also steroid hormones, thyroid hormones and other analytes of interest. Charcoal stripping removes more than just lipids; it creates a hormonally depleted matrix.
The most common mistake: using charcoal-stripped serum for lipemia interference studies. Charcoal removes hormones as well as lipids — creating a matrix effect from hormone depletion on top of the lipemia effect, mixing two variables in the same study.
| Parameter | Delipidated | Charcoal Treated |
|---|---|---|
| Lipids removed | Yes | Yes |
| Steroid hormones | Retained | Depleted |
| Thyroid hormones | Retained | Partially depleted |
| Proteins (albumin, IgG) | Retained | Retained |
| Optical clarity | Clear | Clear |
| CLSI EP7 lipemia study | Correct choice | Not recommended |
| Steroid immunoassay calibrator | Not suitable | Correct choice |
| Lipid metabolism cell culture | Correct choice | Not suitable |
Product Variants
Entfettetes Humanserum
Lipoproteins and free lipids removed. Hormones, proteins and complement retained. Standard matrix for CLSI EP7 lipemia interference studies, general IVD calibrator development and lipid metabolism research. EU-qualified donors, full IVDR documentation available.
- Lipids removed — optically clear
- Hormones retained
- Proteins retained (albumin, IgG, complement)
- CLSI EP7 lipemia study matrix
Human Serum Delipidated + Ultra-Low IgG
Delipidation combined with IgG depletion — lipid-free and immunoglobulin-depleted. For immunoassay applications where both lipemia interference and antibody interference must be eliminated simultaneously. Specialist matrix for antibody-free calibrator development.
- Lipids removed
- IgG depleted to ultra-low levels
- Reduces antibody-related matrix effects
- Immunoassay calibrator matrix
Human Serum Double Charcoal Treated
Activated charcoal treatment — double-processed for maximum depletion of steroids, lipids and small hydrophobic analytes. Standard matrix for oestradiol, testosterone, cortisol and other steroid hormone immunoassay calibrator and control development. Endogenous steroids at or near zero.
- Lipids removed
- Steroids depleted to near-zero
- Thyroid hormones partially depleted
- Steroid immunoassay calibrator matrix
Anwendungen
CLSI EP7 Lipemia Interference Studies
Human serum delipidated (standard variant) is the correct base matrix for CLSI EP7-compliant lipemia interference studies. Lipids are removed to create a clear baseline, then triglycerides or Intralipid are spiked to defined concentrations. Correct sequence: define acceptance criterion first in the study protocol, then run the study.
IVD Calibrator & Control Development
Delipidated serum provides a defined, reproducible matrix for IVD calibrator and control manufacturing. Lot reservation is critical — forced lot changes during product lifecycle generate change control events, comparability studies and potential IVDR notified body notifications.
Steroid Hormone Immunoassay Calibrators
Double charcoal treated serum for oestradiol, testosterone, progesterone, DHEAS, cortisol and other steroid hormone assay calibrators and controls. Endogenous steroids near zero — allows precise analyte spiking at defined concentrations.
Steroid Receptor Research (ER, PR, AR)
Charcoal treated serum for culture of cells expressing oestrogen receptor (ER), progesterone receptor (PR) or androgen receptor (AR) — removes endogenous ligands that would activate receptors and confound experimental treatments.
Lipid Metabolism Research (LDLR, HMGCR)
Standard delipidated serum for cell culture studies of cholesterol uptake, LDL receptor regulation, HMGCR activity and fatty acid metabolism. Removes lipoprotein background while retaining hormones that regulate lipid metabolism pathways.
Endocrine Disruption Testing
Charcoal treated serum as cell culture medium supplement for endocrine disruption testing — eliminates endogenous steroid background to create a clean baseline for evaluating putative endocrine-disrupting compounds at low concentrations.
Product Information
| Product type | Human Serum Delipidated — three variants (see above) |
| Processing | Standard: physical delipidation · Advanced: delipidation + IgG depletion · Steroid-Free: double charcoal treatment |
| Lipid content | Depleted to near-zero in all variants |
| Steroid content | Retained (Standard/Advanced) · Near-zero (Double Charcoal) |
| IgG content | Standard: normal · Advanced: ultra-low · Double Charcoal: normal |
| Donor gender | Male donors available on request (HLA alloantibody-free) |
| Blood type | Mixed pool standard · AB pool on request |
| Filtration | 0.2 µm sterile filtered |
| Endotoxin | Tested per lot — LAL method |
| Viral screening | HBsAg, HCV, HIV-1/2, West Nile Virus — negative per FDA/EMA requirements |
| Herkunft | EU and US-qualified donor centres — processed in Germany |
| Volumes | 10 mL, 50 mL, 100 mL, 500 mL · Bulk on request |
| Storage | −20°C · Batch reservation available — no prepayment |
| Documentation | CoA, CoO, Donor Screening Report · IVDR documentation available |
| Regulatory status | For research and IVD manufacturing use |
Frequently Asked Questions
Do I need delipidated serum or charcoal stripped serum for my study?
Delipidated serum removes lipids only — hormones are retained. Charcoal stripped serum removes lipids plus steroid hormones and other small hydrophobic molecules. Use delipidated for CLSI EP7 lipemia interference studies and general IVD calibrator matrices. Use charcoal treated for steroid hormone assay calibrators and steroid receptor cell culture. Using charcoal-stripped serum for lipemia interference studies is the most common mistake — it introduces hormone depletion as a second variable in your study.
Why is lot reservation important for delipidated serum?
IVD calibrators and controls are validated against a specific serum lot. Once that lot is gone, any lot change triggers a change control event, a comparability study, potential notified body notification under IVDR, and production downtime. The total cost of a forced mid-production lot change at a mid-size IVD manufacturer typically ranges from €20,000–50,000. Reserve your full project lifecycle requirement on day one — SeamlessBio holds the lot in EU stock at no prepayment.
What IVDR documentation is available?
Full IVDR-relevant documentation package available on request: CoA per lot, CoO, Donor Screening Report, TSE/BSE Statement, viral marker testing data. Contact us for application-specific documentation requirements.
Related Products
Request Human Serum Delipidated — Quote or Sample
All three variants available. Free test samples. Batch reservation for IVD programmes. IVDR documentation on request.
Serum processed in Germany (Passau) by SeamlessBio. For research and IVD manufacturing use.
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