Lateral Flow Service
HK-Dtech proposes custom development of Lateral Flow Immunoassay (LFA) that is subjected to a thorough and rigorous process to guarantee excellent quality and reproducibility.
We offer the development, validation, and the manufacturing of a ready-to-use LFA kit that fit with the customer’s needs.
The first step of the development process is to define the specifications of the project and the best strategy to be applied. One or more recommendations could be proposed in function of:
- Type of test: serologic or antigenic (competitive or sandwich formats).
- Targeted analyte: antibody, protein, biomolecules, peptide, small molecule, etc.
- Types of readouts: Quantitative, Semi-quantitative, qualitative.
- Matrix: serum, plasma, urine, saliva, water, etc.
- Evaluation and selection of the best components: membrane, strip, buffer, antigens, bioreceptor (proteins, antibodies, or DNA).
Precise and optimal performance conditions are studied for each step within the test protocol. At this point, we evaluate and optimize the best strip materials (nitrocellulose membrane, conjugate, sample, absorbent pads) and parameters (buffers, blocking reagents, capture bioreceptors and detection bioreceptors concentration, time of migration, stripping condition)
Validating the method ensures results are reproducible, reliable, robust, and accurate. Validation of the analytical method will be subjected to the following experimental checks:
- Specificity (the method must differentiate the targeted analyte from all other matrix components)
- Linearity (range, LLOQ)
- Sensitivity (LOD)
- Accuracy (spiking recovery test)
- Precision (repeatability = intra assay, inter assay; reproducibility = inter laboratory assay, or on different days or different plates) Robustness (defined as the ability to remain unaffected by small variations in method parameters. These parameters could be incubation temperature, temperature of used components or varied incubation time due to time delay during pipetting).