We can supply you with any volume of samples, from small to large-scale to meet your own individual requirements  [more]

 

in.vent Diagnostica is a partner in funded projects

Innovative and forward-looking test systems

Are you looking for a competent partner for the customised development of immunoassays for medical in vitro human diagnostics?

Our work is based on many years of experience gained in a significant number of successful development projects. Our service portfolio extends from the implementation of feasibility studies for newly detected parameters, through assay development up to production and quality control. This includes the automation of manual tests, the drafting of technical documentation and CE labelling in accordance with relevant licensing regulations. The assay platforms that we use include coated-tube assays, ELISA and lateral flow devices.

 

We satisfy your requirements precisely

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We guarantee the optimised and transparent implementation of your development project.

 

Rapid test development

As experts in the use of membrane-based rapid test systems (lateral flow devices, dipsticks), we can provide our customers with a comprehensive rapid test development and production service, from feasibility study to CE-labelled, ready-to-deliver product.

Our state-of-the-art production units and highly qualified personnel guarantee that we can deliver maximum quality and flexibility in all phases of the product lifecycle.

We adapt to your requirements by providing either individual service modules or a fully comprehensive service.

Feasibility studies

Perhaps you have a product concept or an assay system that already works (ELISA, coated tube etc.)?

We can implement a feasibility study to deliver fast information about feasibility and adaptability to a rapid test system.

After the study, you receive a comprehensive report providing information about functionality, LOT-to-LOT stability, precision and clinical utility, and thermal and humidity performance of the assay system. Obviously, we also provide you with an initial estimate of unit costs.

Customised development

If you are happy with the feasibility study findings, you can commission us to perform all aspects of assay development, including CE labelling.

At the end of the development process you receive a comprehensive product dossier, which includes all of the production and testing documents that you will need to produce the assay.

If you like, we can also produce the assay on your behalf (see Production).

Production

We are pleased to implement your production order. We adapt marketable rapid tests to your production equipment's requirements and produce them in the numbers you require. We can deliver anything from small-scale prototype runs to several millions of test strips every year.

Packing service

We pack your diagnostics equipment or biotechnological products. They are shrink wrapped in a four-sided plastic bag that can be printed to your specifications with LOT number, batch number or customised text. The packaging protects your products from light, moisture, dust, dirt and physical wear.

Quality control (QC)

We can perform ISO-compliant quality controls on products that we manufacture, products manufactured on your premises or products that are purchased externally. We create a requirements profile, including the necessary approval criteria for you, develop the test process, provide test samples and store retained samples. Our customers always receive a comprehensive set of documentation.

We help you to optimise your production process!

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