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In Vitro Diagnosis
In Vitro Diagnosis
In Vitro Diagnostic Solutions aims to provide accurate and efficient diagnostic support to the medical field. Through continuous technological innovation, we develop high-quality reagents and advanced diagnostic instruments. We strictly control the quality of raw materials, standardize the production process, and conduct comprehensive testing of finished products to ensure that they meet the standards.
In Vitro Diagnostics Development Process
Target identification
Target identification evaluates whether a target can be detected using existing technologies and resources. There are three types of targets: proteins, antibodies, and nucleic acids. Common examples include pathogen protein epitopes, cytokines, enzymes, etc., and the likelihood that they will be valid targets is investigated to lay the groundwork for subsequent work.
· siRNA/miRNA/ASO synthesis service
· Full-length 16s, 18s, and ITS amplicon sequencing
· NGS Safety Evaluation of Protein Drugs
In vitro diagnostic method development and optimization
Determine the assay format (molecular, antigen capture, antibody detection) before designing the experiment. Common assay formats are ELISA, lateral flow, PCR/GECE, cell or tissue assays. Analytical method development takes into account controls, conditions and reagents. Optimized conditions are designed to ensure sensitivity, specificity, and reproducibility.
Production and Quality Control
In production, we strictly manage raw materials, screen suppliers, inspect receipts; control processes, manage the environment, operate according to regulations, maintain equipment; select packaging materials and accurate labeling. On quality control, set performance indicators and make standard documents; build a whole-process inspection system and validate the method, set up control points to monitor and collect feedback to improve the quality using data analysis.
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