Welcome to our advanced Cytocompatibility Test service, designed to assess the biocompatibility of materials and extracts using in vitro cytotoxicity techniques based on ISO 10993-5:2009 standards. These tests offer a crucial step in ensuring the safety and effectiveness of medical devices and materials before progressing to in vivo animal testing. By utilizing primary cells and cell lines, our service enables you to gain essential insights into cytocompatibility, toxicity, and cell behavior in response to various materials and chemicals.
1. Direct Contact Assessments:
We tailor our protocols to suit your material's density and structural form, including polymers, metals, and ceramics. Through direct placement of test materials above or below cultured cells, we evaluate reactions using methods like membrane elution and agar diffusion. Reactivity of the test sample is indicated by malformation, degeneration, and lysis of cells around the test material. Fluorescence staining, SEM imaging, and cell differentiation ability are also available to observe the cell adhesion, proliferation, and differentiation with the tested materials.
2. Indirect Quantitative Assays:
Following ISO 10993-5:2009, we employ the MTT cytotoxicity assay for quantitative assessment of cellular metabolic activity, reflecting viability, proliferation, and cytotoxicity. This colorimetric method measures the reduction of yellow 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide by mitochondria, offering a precise indicator of living cells. Our quantitative approach extends to both extracts and direct contact, using MTT and other similar kits such as CCK-8 (Cell Counting Kit 8).
Experience the power of our Cytocompatibility Test service at Matexcel, where science meets ethics in ensuring the safety and reliability of medical devices and materials. We may also customize the test plan specific to you according to your requirements. Contact us today to embark on a journey of comprehensive biocompatibility assessment and responsible product development.