Development of rapid IVD tests
With the VELLAP development platform, your project starts with a head start that can make the decisive difference in the market. We can rely on a large toolbox of processes, components and technologies and maximize the chances of success from the start of the project.
We ensure compatibility with the AI-based mobile application VELLAP SCAN, which enables the quantification of the product without a measuring device.
Our partner Senova is an internationally active, medium-sized company that specializes in the development and production of high-quality immunological rapid tests for in-vitro diagnostics. The range of services includes assay development including the implementation of feasibility studies, the production transfer of development results, the production of Mastersheets cassettes as well as the IVDR-compliant approval of lateral flow assays.
The VELLAP development scheme guarantees regulatory compliance of the entire process with EN ISO 13485:2016 and IVDR.
A Lateral flow immunoassay
B
Senova LFA technologies
C
Flowify AI LFA technology
D
VELLAP platform
E
Application requirement
1
Write a development plan
2
Stakeholder requirements
3
Product requirements
4
Product design specifications
5
implementation
6
Verify components
DF
Freeze design
DT
Perform design transfer
9
Analytical performance evaluation
10
Validation
11
Release
12
Market launch
Feasibility studies
If the information is not yet known, we will be happy to support you with antibody screening and establish a functional LFA pattern based on standardized protocols in order to check whether the specified product requirements can in principle be achieved.
Test development
The test development includes extensive optimization of all individual components of the LFA. If necessary, experiments on the design of sample buffers or the conception of a method for sample preparation are also included. At the end of the development, an LFA prototype is obtained, which forms the basis for further steps towards validation.
Component verification and production transfer
The test prototype is tested for reproducibility with buffer and real samples. Manufacturing and testing instructions are then drafted and the production of the components is expanded to production scale. To monitor success, three production batches are produced and tested using extended testing instructions.
Validation
The validation phase is based on the IVDR specifications and is carried out with 3 batches of the test. This includes both analytical and clinical performance assessment, flexibility and usability tests and the recording of storage stability. The documentation is carried out based on the specifications of our quality management system.
Core competencies
- Development of high-quality immunological rapid tests in sandwich or competitive assay format for the sensitive detection of proteins, hormones, nucleic acids, antibodies or microorganisms
- Synthesis of different gold and silica nanomaterials for visual detection in LFA
- Test evaluation with Vellap Scan mobile phone app or portable Igloo reader
- BioDot reel-to-reel production of mastersheets
- Production capacity of up to 500,000 cassette tests per month
- Quality management system with EN ISO 13485:2016