Human Plasma
Normal Human Serum
(BCB-1: Biological Control Base-1)
JTC’s Normal Human Serum is manufactured from fresh frozen CPD human plasma, defibrinated and removed from anticoagulant and additives, applying JTC’s proprietary processing technology.
JTC’s Normal Human Serum is used as a base matrix for manufacturing liquid / frozen and lyophilized, Biochemistry Multi Panel- and Single Controls and Calibrators.
Features
• BCB-1 (Human Serum, processed) is used for Calibrators and Multiple Chemistry Controls as well as for EQA chemistry in liquid/frozen or lyophilised form.
• CPD human plasma units are derived from human whole blood of European origin tested and certified negative for HBsAg, anti-HBV, anti-HIV 1/2 and HCV/HIV-NAT with CE marked test kits.
• Excellent switchability.
• Electrolyte levels are within normal ranges.
• All BCB materials are filtered through a membrane smaller than 0.2 µm and have a bioburden of less than 100 cfu/mL.
• Optional addition of preservatives if required.
• Each shipment to the customer is accompanied by a detailed certificate of analysis (CoA).
• Customized manufacturing to match specific requirements is offered.
Filling Volume
1,5 L in PE canisters.
Other filling sizes on request.
Form and Stability
Frozen at < minus 20°C (3 years).
Order Information
Normal Human Serum, Cat.No.: H4801CB1.
Delipidized Human Serum
(BCB-2: Biological Control Base-2)
JTC’s Delipidized Human Serum is manufactured from fresh frozen CPD-human plasma applying JTC’s proprietary technology for defibrination/delipidation.
JTC’s Delipidized Human Serum is the preferred base matrix for manufacturing Immunology/ Protein-Controls and Calibrators as well as liquid controls in general.
Features
• BCB-2 (Human Serum, Delipidized) is applied for Special Panels and Single Controls such as Protein Controls or Cardiac Markers.
• The CPD human plasma units used for JTC’s delipidated human serum are of European origin tested and certified negative for HBsAg, anti-HBV, anti-HIV 1/2 and HCV / HIV-NAT with CE marked test kits.
• Traceability to donor units is documented.
• Optical clear base matrix (O.D. less than 0.300, 540 nm).
• Electrolyte levels are within normal ranges.
• Cholesterol less than 0.3 mM, Triglycerides less than 0.5 mM.
• All BCB materials are filtered through a membrane smaller than 0.2 µm and show a bioburden of less than 100 cfu/mL.
• Low turbidity and excellent filtration performance for processing.
• Optional addition of preservatives if required.
• Each shipment to the customer is accompanied by a detailed certificate of analysis (CoA).
• Customized manufacturing to match specific requirements is offered.
Filling Volume
1,5 L in PE canisters.
Other filling sizes on request.
Form and Stability
Frozen at < minus 20°C (5 years).
Order Information
Delipidized Human Serum, Cat.No.: H4701CB2.
Charcoal Absorbed Human Serum
(BCB-3: Biological Control Base-3)
JTC’s Charcoal adsorbed Human Serum is manufactured from fresh frozen CPD-human plasma and offered in 2 variants: Delipidized or Non-Delipidized, applying JTC’s proprietary technology for Charcoal adsorption.
JTC’s Charcoal adsorbed Human Serum is preferably used as the base matrix for manufacturing of Immunoassay Multi- and Panel Controls/Calibrators.
Features
• BCB-3 (Human Serum, De-lipidated, Hormone Free) for all types of Immunoassay, Serology and NAT Quality Controls.
• The CPD human plasma units used for JTC’s delipidated human serum are of European origin tested and certified negative for HBsAg, anti-HBV, anti-HIV 1/2 and HCV / HIV-NAT with CE marked test kits.
• Traceability to donor units is documented.
• The following analytes are reduced by adsorption: fT4, fT3, cortisol, E2. Testosterone, Progesterone, Aldosterone and DHEA-S.
• Electrolyte levels are within normal ranges.
• All BCB materials are filtered through a membrane of less than 0.2 µm and show a bioburden of less than 100 cfu/mL.
• Low turbidity and excellent filtration performance for processing.
• Optional addition of preservatives if required.
• Each shipment to the customer is accompanied by a detailed certificate of analysis (CoA).
• Customized manufacturing to match specific requirements is offered.
Filling Volume
1,5 L in PE canisters.
Other filling sizes on request.
Form and Stability
Frozen at < minus 20°C (3 years).
Order Information
Charcoal adsorbed Human Serum (BCB-3A), Non-delipidized, Cat. No.: H4501CB3.
Charcoal adsorbed Human Serum (BCB-3B), Delipidized, Cat. No.: H4601CB3.
IVD Human Serum
(BCB-4: Human Serum, Delipidated, Protein Elevated)
Features
• High commutable Matrix for the preparation of Serum Protein Controls.
• Offered in liquid / frozen form.
• Free of turbidity OD < 0,300 (540 nm).
• Sterile filtered, bioburden < 100 cfu/mL.
• Protein, Tot.: 130 – 150 g/L.
• Filling Volumes: 500 mL, 1000 mL, and 2000 mL.
• Serum Proteins include: Albumin, Acid Glycoprotein, alfa-1-Antitrypsin, C3, C4, Haptoglobin, IgA, IgM, IgG, alfa-2-Macroglobulin, Transferrin, Apolipoprotein A-I/II, Apolipoprotein B and Ceruloplasmin.
• Enrichment of Serum Proteins by smooth, validated proprietary processing techniques.
• Adjustment of Protein, Tot. according to customer’s specification, if required.
• Certificate of Analysis covers Total Protein and the Serum Proteins shown above.