Biomex GmbH products

Get an idea of the suitable units from our inventory of over 5000 Disease State Plasma units. All plasma samples were accepted and tested in our plasma centers in Heidelberg and Munich in accordance with all the  applicable laws and standards. Thanks to our large donor client base, we can guarantee quantities and specifications for years to come. With us you will be getting a long-term partner. 

Biomex provides high quality human plasma for diagnostic controls and calibrators. We deliver a number of specifications from our stocks, and on request offer customer-specific lots with batch sizes of between 50 and 200 liters.

Biomex offers high quality human plasma for diagnostic controls and calibrators. Our processed plasmas are defibrinated, diafiltered, treated with activated carbon or delipidated. A combination of different procedures is possible. All products are sterile filtered before filling and produced according to cGMP with regular quality controls.

The Biomex GmbH CMV IgM Seroconversion Panel consists of 15 members with each member containing 0.5 mL of human plasma. This panel illustrates the onset and decline of IgM and IgG Cytomegalovirus antibodies from one individual over a period of 99 days.

Biomex offers both positive and negative patient samples that are collected in our own donation centers in Munich, Heidelberg and Africa. In addition, we also acquire over 150,000 left-over samples per year from our global network of laboratories. 

The matched sets are used to reveal any potential influential effects of various anticoagulants on the test result. Available from healthy donors in panels of 5 or 10 samples. We would also be happy to accept any matched sets at the customer`s request. All donors are tested negative/non-reactive for anti-HIV, anti-HCV and HBsAg using CE certified tests. We can also of course carry out sample storage stability studies for you - utilize our service for your project.

Our Seroconversion Panels (SCPs) were developed from non-processed plasma. This was done by collecting plasma from an individual during the evolution of an infection, and the ensuing immunological response. Our seroconversion panels contain defined infection markers and include extensive sample data for comparative analysis. Our SCPs are intended to be used in standard tests by diagnostic manufacturers and researchers during assay development, evaluation, troubleshooting, and post-monitoring of IgM/IgG antibody test systems and methods. In addition, these panels also serve as a validation tool for diagnostic sensitivity, for measuring analytical sensitivity, for identifying cut-off values, or for investigating the humoral immune response to a specific infection.

CTS serology panels are used to meet the requirements of the new European Regulation 2017/746 on in-vitro-diagnostics. This regulation replaces the previous Directive 98/79/EC and will need to be implemented by May 26, 2022. 

In order to validate diagnostic specificity for assays that need not be tested according to the comprehensive specifications of the CTS, we also offer a variety of different panels: Cross-reaction panels (RF+, HAMA,...), Inhibition panels (endogenous factors), Negative samples, Hospitalized patient panels, Cross-contamination panels, Serum/Plasma equivalence panels, Blood bank marker panels,

QC release panels (serum and plasma): Positive - low, medium, high range, Negative - no analyte, no virus, no specific antibody, Cut-off - values at range of LoD to clinical decision point