Custom Immunoassay Manufacturing & Quantitative Analysis
We develop and produce customized Immunoassays according to your specific requirements – from concept to full-scale production under ISO 13485 standards, ensuring full IVDR compliance for your technical documentation. Whether qualitative, semi-quantitative, or high-precision quantitative detection: our assays are tailored to your target analytes, sample matrices, and application scenarios.
Our Immunoassay Services at a Glance
- Lateral Flow Assays (LFA) – rapid, user-friendly tests for point-of-care applications
- ELISA (Enzyme-Linked Immunosorbent Assays) – proven platform for accurate quantitative analysis
- LIA (Luminescence Immunoassays) – highly sensitive detection for diagnostic and research use
- Magnetic Particle-Coupled Assays – for automated systems or particularly sensitive applications
In combination with our Study Sample Analysis, your immunoassay data can be evaluated even more accurately – ensuring maximum reliability of your diagnostic results.
Your Benefits with ASKA's Immunoassay Development
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ISO 13485 certified – IVDR-compliant quality and safety standards.
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Customized Development – of immunoassays – precisely tailored to your analytes, sample matrix, and application
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High Sensitivity and Specificity – through optimized reagents, buffer systems, and validated test conditions
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Handling of Complex Matrices – such as serum, urine or environmental samples, in compliance with regulatory standards
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End-to-End Support – from feasibility analysis through development to series production and tech transfer
Our Services in Immunoassay Development
- Feasibility Studies & Assay Design: Evaluation of technical feasibility, selection of suitable formats, and development of a custom assay design
- Screening of Antibodies, Antigens & Conjugates: Selection and testing of high-specificity reagents – including labeling and stability analysis
- Development of Robust Test Systems: Optimization of buffers and reagents for maximum sensitivity, stability, and ease of use
- CE-IVD & IVDR-Compliant Validation: Analytical and clinical testing in accordance with ISO 13485 – including full technical documentation
- Scaling to Series Production: Transfer into validated manufacturing processes – from pilot to large-scale batches
- Technology Transfer (Tech Transfer): Seamless transfer to your production environment – including documentation, training, and quality assurance
Your Project with Immunoassays – Get in Touch!
If you’re planning a new immunoassay or looking to further develop an existing system, contact us today. Our experienced team will advise you individually, analyze your requirements, and develop tailored assay solutions – fast, reliable, and fully compliant with the highest quality and IVDR standards.
For functional analyses in cell-based systems, we recommend our Bioassays.
FAQ – Frequently Asked Questions about Immunoassay Development
What sample matrices can be validated in your immunoassay services?
We validate assays for a wide range of biological matrices including serum, plasma, urine, saliva, and CSF. We also handle complex matrices such as cell lysates or environmental samples.
Do you develop multiplex immunoassays for simultaneous detection?
Yes. Our immunoassay services include the development of multiplex assays (e.g., bead-based or planar) to detect multiple analytes in a single sample, maximizing data output and cost-efficiency.
What is the typical timeline for custom immunoassay development?
The timeline depends on complexity and format (e.g., ELISA vs. LFA). Typically, feasibility and prototype development take 3 to 6 months, followed by validation.
Can you integrate customer-supplied antibodies or antigens?
Yes. We can integrate your proprietary reagents. We perform antibody pairing, conjugation, and characterization to ensure they meet the performance requirements of the final assay.
Do you offer assay validation and clinical performance evaluation?
Yes. We support the entire validation process, including analytical performance studies (precision, specificity, stability) and documentation for clinical performance evaluation according to IVDR/ISO 13485.
Which specific assay formats do you specialize in?
We specialize in Sandwich ELISA, Competitive ELISA, Lateral Flow Assays (LFA), and CLIA/LIA formats, tailored to your sensitivity and throughput needs.