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IVD Applications

In vitro diagnostics (IVD) examine samples such as tissue, blood or others to detect diseases and monitor health conditions. The most common IVD assays utilize technologies like PCR, ELISA, CLIA, lateral flow, and immunohistochemistry. These methods identify specific DNA/RNA segments or rely on specific antibody-antigen interactions to detect target components. A crucial element of the latter is the use of suitable antibodies. The sensitivity and specificity of these antibodies directly impacts the accuracy and reliability of the assays.

BioGenes specializes in producing high-quality antibodies in scalable amounts that meet the stringent requirements of IVD assays. This includes the development and production of both, monoclonal and polyclonal antibodies. Monoclonal antibodies are ideal for eliminating cross-reactivities due to their ability to specifically target a single epitope and are therefore particularly crucial in fields such as cancer diagnostics, infectious disease diagnostics, and biomarker measurement. On the other hand, polyclonal antibodies have the advantage of binding to multiple epitopes on an antigen, making them highly versatile for various applications. 

BioGenes offers fully customizable immunization protocols for the generation of polyclonal antibodies. Clients can tailor these protocols to their specific needs, including the scheduling of boosts and bleedings, in consultation with our project management. Furthermore, we offer full flexibility to determine the immunization period and the number of animals involved. In addition to these tailored services, we ensure the superior quality of antibodies through affinity purification (total or specific IgG), making them highly reliable for IVD applications. Our strategy ensures consistent high quality antibodies throughout the life cycle of your IVD

Phase 1 – Expert Consultation

  • Definition of immunization strategy (protocol, species, animal number)
  • Extensive discussion between BioGenes’ scientists, project manager and customer to provide a specific offer including defined work phases

Phase 2 – Immunization

  • According to the selected species and protocol
  • Immunization protocol can be extended flexible according to customer needs with monthly boots and bleeds

Phase 3 – ELISA Titer Tests

  • Of pre-immune sera and antisera according to selected protocol
  • opt.: titer test of monthly bleed

opt. Phase 4 - Affinity Purification

  • Antibody purification via an affinity column chromatography using protein A or G or the antigen 

Phase 5 – QC & Deliverables

  • Ensuring a steady and reliable supply of antiserum or purified antibodies throughout the project to meet ongoing needs for IVD development and production
  • opt.: Dialysis of purified antibodies to desired buffers
  • opt.: Quality control of the purified antibodies using ELISA, SDS-Page or 1D Western Blot

Duration: dependent on the project goals and requirements

What Our Customers Say About Us

Bühlmann Laboratories AG

»For over a decade, BioGenes has been an essential partner for our company. Their competence, dedication, and openness to customization make them a standout supplier. They consistently provide innovative solutions, helping us navigate challenges effectively. Working with BioGenes has been a positive experience, and I highly recommend them to any organization seeking reliable and flexible solutions.

Dr. Daniel Hauser, Head Production II

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FAQs

Which technologies are used as IVD Assays?

  1. ELISA (Enzyme-Linked Immunosorbent Assay) and CLIA (Chemiluminescent Immunoassay) are essential for measuring the presence of antibodies or antigens in a sample, providing quantitative results that are critical for diagnosing conditions like autoimmune diseases and infections. 
  2. Immunohistochemistry is a technique used primarily in pathology to visualize the presence and location of specific proteins within tissue sections, aiding in the diagnosis and classification of cancers.
  3. PCR (Polymerase Chain Reaction) is widely used for its ability to amplify and detect specific DNA or RNA sequences, making it invaluable in identifying infectious agents and genetic disorders.
  4. Lateral flow tests, familiar to many as the format used in home pregnancy tests and rapid COVID-19 tests, offer quick and easy detection of specific analytes.