IVD Immunoassay Development

Future Diagnostics develops full IVD immunoassays on demand and offers flexible support in feasibility & optimization, verification & validation projects, and technical transfer to manufacturing for third parties.

Our exploratory phase teams run projects for conjugation, biomarker qualification, benchmarking and bead selection/coating to withstand the golden standard in the market on a daily basis.

The development of an immunoassay involves choosing a format, gathering the right components, and constructing a good working protocol. Optimization of assays takes systematically adjusting and testing all components and variables to ensure results are robust and accurate. The immunoassay formats provide different levels of specificity, sensitivity, simplicity, and speed. They also require different numbers and varieties of components. When we develop an immunoassay from scratch, this is often because the target of interest is a “new” biomarker, in which case a known pair of antibodies may not be available. Searching and matching for the right antibodies may be required.

Expertise and Experience

Future Diagnostics is strongly familiar with various types of immunoassays, such as:

  • ELISA
  • EIA
  • CLIA
  • Automated Platform based assay
  • Paramagnetic particle based assay
  • Microarray assays
  • Multiplex bead assay
  • Point of care assays
  • Microfluidic assays
  • Enzyme multiplied immunoassay technique (EMIT)
  • Turbidimetric assays

Future Diagnostics is highly experienced in using the following tracers:

  • Acridinium Ester
  • Alkaline Phosphatase (AP) (Colorimetric and Chemiluminescent)
  • Bioluminescence
  • Fluorescence
  • Horseradish Peroxidase (HRP) (Colorimetric and Chemiluminescent)
  • Isoluminol
  • Colloidal (nano) Gold Particles

We are your partner for any type of analyzer you want to work with.

How we work? Have a look at our Assay Development Cycle For all disease areas

The assays from Future Diagnostics are developed across different disease areas. You can think about cardiovascular, therapeutic, autoimmune, bone metabolism, infectious diseases, tumor markers, reproduction/fertility, endocrine, anemia, diabetes.

Our highly qualified teams, profound experience and our efficient working processes enables us to help you bring your assay to market within months.

The assays are developed under ISO 13485 standard and are ready for CE/IVD and/or FDA approval. The complete design history file is provided with a.o. Design input Document, Risk Management Reports, Verification Report, Validation Report, Stability Report, Final Manufacturing Documents.

Enzyme-Linked Immuno Sorbent Assay (ELISA) or Enzyme Immunoassay (EIA) is a commonly used method for detecting antigens in microwell applications.

“ELISA…is still a popular platform in assay development”

The ELISA (enzyme-linked immunosorbent assay) is a popular method for protein detection and quantification. This type of biochemistry assay uses a solid-phase enzyme immunoassay (EIA) to detect the presence of a substance, usually an antigen, in a liquid sample or wet sample. Performing an ELISA involves at least one antibody with specificity for a particular antigen. ELISAs are simple to carry out and they are designed to rapidly handle a large number of samples in parallel. The ELISA still is a very popular choice for the evaluation of various research and diagnostic targets.

Complex?

ELISAs can be quite complex and there are many things to consider with the development of an ELISA. The first is what format to use; direct, indirect, sandwich, Competition or Inhibition ELISA. Formats differ in how the target antigen is captured and detected.

puzzelstukDirect and indirect ELISA both immobilize the antigen on the microtiter plate and then use either a labeled primary antibody (direct) or primary antibody and labeled secondary antibody (indirect) to detect the antigen. This type of ELISA has two advantages: It is faster, since fewer steps are required and it is less prone to error, since there are fewer steps and reagents.

puzzelstukSandwich ELISA is considered the most robust format because the antigen is “sandwiched” between two primary antibodies. The first antibody (capture) is coated to the microtiter plate. Next, the analyte or sample solution is added to the well. A second antibody layer (detection) follows this step in order to measure the concentration of the analyte.

puzzelstukCompetition or Inhibition ELISA is the most complex ELISA, and is used to measure the concentration of an antigen (or antibody) in a sample by observing interference in an expected signal output.

puzzelstukELISPOT (Enzyme-Linked ImmunoSpot) assay is a sensitive and accurate detection of uncommon antigen-specific B- or T-cells and is able to show single positive cells within a population of peripheral blood mononuclear cells.