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ProductLaboratory Equipment

Electrochemical Biosensor

Zhubei, Hsinchu, Taiwan

Biosensor device employing electrochemical detection principles for molecular analysis. Applicable to various diagnostic assays requiring precise electrochemical measurement capabilities.

Manufactured by

Zhubei, Hsinchu, Taiwan

Immino-reagent manufacturing plant for ELISA kit rapid strip test. •Intended Use: Quantitative detection of MMP-1 in human saliva, aiding OSCC diagnosis in individuals aged 30–90. •Sample Sites: human saliva. •User: Qualified laboratory professionals (1) EarlyFound® MMP-1 ELISA kit -Quantitative data (concentration) -Easy performed in clinical lab -Suitable for high throughput test -Validation in 1,031 saliva specimens -Sensitivity: 85.6% (95% CI: 81.4–89.0%) -Specificity: 78.7% (95% CI: 75.5–81.6%) -Accuracy: 80.9% (95% CI: 78.4–83.2%) -Use scenario:Utilized with ELISA reader equipment within hospitals for the auxiliary diagnosis of oral cancer and for monitoring the prognosis of oral cancer. -Obtained medical device approvals from CE (IVDD), Singapore HSA, Australia TGA, Hong Kong MDD, Thailand FDA, and Vietnam MoH. (2) EarlyFound® MMP-1 Rapid Strip Test -Qualitative data -Easy performed by oneself -Suitable for point-of-care test -Validation in 1,029 saliva specimens -Sensitivity: 79.8% (95% CI: 75.1–83.8%) -Specificity: 86.2% (95% CI: 83.5–85.6%) -Accuracy: 84.2% (95% CI: 81.8–86.3%) -Use scenario:For first-line oral cancer screening and suitable for use in out-of-hospital settings. -Obtained medical device approval under CE (IVDD); registration reviews are currently in progress with Singapore HSA, Australia TGA, and Hong Kong MDD.

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