Applications

Our monoclonal antibodies are designed for a wide range of in vitro diagnostic (IVD) applications, providing precision and reliability across many areas. From early disease detection and biomarker identification to pathogen detection and chronic conditions monitoring, our antibodies are engineered to deliver accurate results in diagnostic assays. Whether used in immunoassays, ELISA, or lateral flow tests, our solutions are designed to meet the needs of laboratories and healthcare providers, helping to advance patient care and improve diagnostic outcomes.
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Bcell Design Human Fc Monoclonal antibodies IVD

In vitro diagnostics (IVD) uses

Our products are used in IVD assays, which are typically performed on patients samples outside the body, as opposed to in vivo diagnostics, which require direct testing on the patient’s body (e.g., MRI or x-ray).
Bcell Design Human Fc Monoclonal antibodies IVD
In Assays and Kits

Our human Fc monoclonal antibodies are the top choice for replacing disease state plasma, serving as critical positive controls and calibrators in IVD kits. Validated on platforms like DiaSorin LIAISON XL, BioMérieux Vidas, and bioVendor KleeYa, they ensure consistent, reliable assay performance.

Produced under ISO 9001-certified systems and compliant with IVDR and FDA standards, our mAbs are trusted worldwide. Choose our antibodies to eliminate ethical and supply chain concerns while improving lot-to-lot consistency.

In Quality Control

Whatever immunoassay testing platform you use, our human Fc mAbs can be used to check antigen absorption and assay performance. They ensure consistent signal generation across different batches, reducing the need for revalidations and saving you time and resources.

  • ELISA
  • CLIA
  • LFIA
  • DOTS
In External Quality Control

Some of them are already in external quality control programs and are usable for all types of immunoassay detecting specific Ig.

Advantages of IVD human Fc monoclonal antibodies

By incorporating our human Fc monoclonal mAbs into your IVD kit development and quality control processes, you’ll deliver more reliable, accurate, and reproducible diagnostic tests—leading to better patient outcomes and improved global health standards.

IgM, IgG, IgE and IgA
Bcell Design Human Fc Monoclonal antibodies IVD IgM IgE IgG IgA
Batch-to-batch reproducibility
Bcell Design Human Fc Monoclonal antibodies IVD reproducibility
High-reactivity: sensitivity, specificity, selectivity, stability
Bcell Design Human Fc Monoclonal antibodies IVD high reactivity
Ready to use

Our approach extends beyond IVD applications

Our human Fc monoclonal antibodies (mAbs) have significant potential for both research and industrial applications. We partnered with Professors Gruel, Rollin, and Pouplard, thrombosis experts from the University of Tours, France, to develop a human Fc mAb for studying heparin-induced thrombosis (HIT).

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From research to industrial use

HIT, where heparin (a blood thinner) triggers dangerous clots, posed a diagnostic challenge. Together, we design for them a human Fc IgG that precisely targets the culprit: the complex PF4/Heparin.

Actually, the products developped in this project are used in 3 different applications: research, IVD and therapeutics.

  • Research: The several clones developed for this project mimic the different antibodies that are found in patients.
  • IVD: 1 product for assay calibration, 1 cell assay, 1 external quality control
  • Therapeutic: 1 mAb candidate for ADC
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