Charcoal stripped human serum with 25-OH-D depleted to < 4 ng/mL — the standard zero-calibrator matrix for Vitamin D IVD assay kits. Also known as: Vitamin D free human serum · Vitamin D stripped serum · 25-OH-D depleted serum. 100 mL to 10+ litres. Full viral screening. No minimum order.
Standard residual specification. Custom residual level available — specify your target at order. Lot-specific analytical data included.
From evaluation volumes to full IVD manufacturing runs. Same documentation and traceability at every scale. No minimum order.
HIV-1/2, HBsAg, anti-HCV, Syphilis per lot. NAT screening on request. Complete donor traceability on file. CoA, CoO, TSE/BSE included.
Based in Passau, Germany. IVDR documentation package on request. 5–10 day lead time to DACH. No import delays.
This product is referred to by different names in the IVD industry and scientific literature. SeamlessBio supplies all of the following under one product:
| Produkttyp | Human Processed Serum (HPS) — Vitamin D Depleted |
| Depletion method | Activated charcoal stripping (dextran-coated charcoal) |
| Residual 25-OH-D | < 4 ng/mL (standard) · custom residual level on request |
| Anticoagulant / base | Serum (clot-based, no anticoagulant) — standard · EDTA plasma base on request |
| Verarbeitung | Delipidated + Vitamin D depleted · 0.2 µm sterile filtered |
| Donor pool | Pooled, mixed gender · full traceability on file |
| Virus-Screening | HIV-1/2 Ab, HBsAg, anti-HCV Ab, Syphilis — per lot |
| NAT screening | HIV-1 RNA, HCV RNA, HBV DNA — on request |
| Lagerung | −20°C · Shelf life 24 months from production date |
| Verfügbare Bände | 100 mL · 500 mL · 1000 mL · 5 L · 10 L · Bulk on request |
| Dokumentation | CoA · CoO · Viral screening report · TSE/BSE statement · SDS |
| IVDR documentation | Extended viral panel · NAT · ISO 13485 certificate — on request |
| Intended use | Manufacture of in vitro diagnostic reagents · Research use only |
| Mindestbestellmenge | Keine Mindestbestellmenge |
| Lieferzeit | 5–10 business days · Large volumes (≥ 5 L) on request |
Human Processed Serum (HPS) Vitamin D depleted is pooled human serum that has been processed by activated charcoal stripping to remove endogenous 25-hydroxyvitamin D (25-OH-D₂ and 25-OH-D₃) and 1,25-dihydroxyvitamin D to residual levels below 4 ng/mL. The matrix is also delipidated — lipoproteins removed to eliminate turbidity that would interfere with photometric assay measurements.
The result is a human serum background free of detectable Vitamin D — used as the zero-standard diluent and base matrix for Vitamin D IVD assay calibrator kits. Spiking defined concentrations of 25-OH-D₂ and/or 25-OH-D₃ into this depleted matrix produces calibrators for the full assay range.
Compatible with automated immunoassay platforms (Roche Elecsys, Abbott Architect, DiaSorin LIAISON 25-OH-D, Siemens ADVIA Centaur) and LC-MS/MS methods (isotope dilution, derivatisation-based). The human serum matrix provides endogenous binding protein background (Vitamin D Binding Protein, albumin) that matches patient samples — critical for assay accuracy across the full clinical range.
Human Processed Serum (HPS) is human serum that has undergone additional processing — typically delipidation and charcoal stripping to remove specific analytes such as Vitamin D, steroids or hormones to below assay detection limits. Standard human serum retains all endogenous analytes and is not suitable as a zero-calibrator base for Vitamin D assays. HPS Vitamin D depleted provides a human matrix with 25-OH-D removed to < 4 ng/mL — enabling accurate calibrator preparation across the full Vitamin D assay range.
Yes — these terms describe the same product category. "Vitamin D free human serum" (used by Golden West Biologicals and Molecular Depot), "Vitamin D stripped serum" (used in clinical trial protocols), "charcoal stripped serum Vitamin D" and "Human Processed Serum (HPS) Vitamin D depleted" (SEQENS IVD / Avantor nomenclature) all refer to human serum processed by charcoal stripping to remove 25-OH-D to < 4 ng/mL. SeamlessBio supplies this product regardless of which terminology your specification uses.
Yes. SeamlessBio supplies HPS Vitamin D depleted from 100 mL evaluation volumes up to 10 litres and beyond for IVD manufacturing runs. Large volume orders (≥ 1 L) are supplied with lot-specific CoA, full donor traceability and viral screening documentation. Batch reservation for production lifecycle supply is available without prepayment. Contact info@seamlessbio.de with your required volume and specification for a quote within 48 hours.
Yes. Standard specification is residual 25-OH-D < 4 ng/mL (undetectable on most immunoassay platforms). Custom residual levels — for example < 2 ng/mL for LC-MS/MS methods with lower detection limits, or a defined low concentration for spike-recovery validation — can be specified on request. Lot-specific Vitamin D analytical data is included with each shipment.
Standard documentation per lot: Certificate of Analysis (CoA), Certificate of Origin (CoO), viral screening report (HIV-1/2, HBsAg, anti-HCV, Syphilis), TSE/BSE statement, Safety Data Sheet (SDS), complete donor traceability on file. Extended IVDR package on request: NAT screening (HIV-1 RNA, HCV RNA, HBV DNA), extended viral panel (anti-HBc, anti-HTLV, HAV Ab), ISO 13485 manufacturer certificate, IVDR Annex I Annex II documentation support.
Yes. HPS Vitamin D depleted from SeamlessBio is intended for the manufacture of in vitro diagnostic reagents — calibrators, controls, standards and EQA specimens. Not for therapeutic use or direct administration to humans. Full IVD-grade documentation available. For GMP-grade material with extended documentation, contact info@seamlessbio.de.
Specify your required volume (100 mL to 10+ L), residual 25-OH-D level and documentation requirements — quote within 48 hours. Free evaluation sample available on request.
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Reservieren Sie Ihre validierte FBS- oder Humanserum-Charge – ohne Vorauszahlung.
Kostenlose Testmuster auf Anfrage.