Our k(now) device and kit have been validated to deliver consistent and reliable results for samples containing a viral load of 23,000 copies/ml, with a 100% agreement at Ct<33 demonstrated in clinical validation.
The BiologyWorks Kk(now) Covid-19 Molecular Test is built upon RT-LAMP (reverse transcript loop mediated isothermal amplification) technology for the qualitative detection of SARS-CoV-2, including all variants. The test is designed to look for parts of the SARS CoV-2 RNA that are less likely to change, or mutate, over time. The molecular response result is determined by real-time fluorescence read-out with the BiologyWorks k(now) Rapid Molecular Detection Device and Platform. The summary overall percent- age agreement with PCR similar PRCR tests is 98.1 percent below Ct 35.
The product is integrated into a comprehensive digital platform that allows clinicians to participate and review test results, regardless of where performed, and for the end-users to receive validated results to permit personal and professional activities. We built our system using Privacy-by-Design principles. We adhere to GDPR and other best practices to ensure data security.