Automated immunoassay system utilizing electrochemical detection methods for biomarker quantification. Suitable for high-throughput clinical laboratory applications.
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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