Detection for: Human Fecal Occult Blood
Test Time: 5 minutes
Sensitivity: 50ng/ml hHb
Relative Sensitivity: 99.2%
Relative Specificity: 98.9%
A total of 532 clinical fecal specimens were collected from hospital patients. These specimens underwent testing using three different lots of the GenaCheck™ Rapid Test Kit for Fecal Occult Blood (FOB) while strictly following the provided Instructions for Use. To establish a comprehensive comparison, the same clinical samples were also subjected to testing using a commercial FOB rapid test. The results of the comparison between the two kits are detailed in the table below. Notably, all three lots of the GenaCheck™ Rapid Test Kit exhibited consistently reliable results, with a relative sensitivity of 99.2% and a relative specificity of 98.9%, respectively. These findings underscore the kit’s accuracy and effectiveness in detecting fecal occult blood, affirming its robust performance in clinical settings.
Genabio is a global leader in the production of over-the-counter self-testing products, with an impressive sales record of over $100 million in the past three years. Our extensive customer base spans across the USA, Canada, the UK, Japan and India.
A significant aspect of our product range is the FDA approval, including the COVID-19 Rapid Self-Test Kit. These sought-after products can be found in thousands of locations, including renowned pharmacy chains like Walgreens, leading hospitals such a NYU Langone Health, accredited laboratories like SV Diagnostics Labs and Molecular Testing Labs, and various government departments.
In 2023, Genabio marked a pivotal moment in initiating our listing and financing efforts in Hong Kong. Simultaneously, we are focused on enhancing our brand identity and emphasizing clinical research within the United States. This commitment to research and development aligns with our expansion plans, which encompass increasing our production capacity in both the United States and China.
Our overarching vision is to be the world’s foremost provider of self-testing solutions, offering precise, user-friendly, and cost-effective health diagnostics for individuals worldwide. Our mission is to enhance global health awareness and accessibility, by delivering quality, FDA-approved self-test kits, by driving innovation, and by expanding our reach to ensure individual scan monitor their health with precision and convenience.
