bKIT - Virus Finder COVID-19 Saliva (32 tests/kit). Up to 64

HYRIS bKITs™ are reagent sets used to analyze specific genetic sequences. They can be used e.g. for the detection of a pathogen in a biological sample, the correct identification of the nature of the sample and a large number of other purposes. Hyris both develops HYRIS bKITs™ in its own R&D center, or adopts third party reagents after a stringent qualification process, thus greatly increasing the number of potential applications easily ported unto the platform. Direct amplification with no need for sample extraction (showing comparable performance to other systems using extracted samples) Targets the viral Nucleocapsid gene (N gene) Up to 24 samples with 1 bKIT (soon up to 64 samples with a 36 wells cartridge and a new bKIT format) Up to 6 patient samples simultaneously (soon up to 16 patient samples with a 36 wells cartridge) Fast sample-to-answer process with positive sample results in less than an hour and negative in <2h Real Time PCR reaction, the gold standard for COVID19 diagnostic QR code to load the analysis protocol Hyris ltd manufactures a molecular test for the detection of SARS-CoV-2 in human specimens. The assay follows the specifications, including primer sequences, described and validated by the CDC and listed by WHO. bKIT Reliability Validated on bCUBE by several clinical studies with a high sensitivity ( >95%, CI 95%) and no false negatives reported [Miscio et al. J Transl Med (2020)] Positive and negative controls to validate the results Internal Control to avoid false negative results Clinical trials concluded with success (at Hospital Pascale/Federico II/Cotugno, IZSLER: Reference center for COVID-19 testing, Hospital Santa Maria delle Scotte in Siena, Center of Civil Health from Ministry of Health of Ukraine). More studies ongoing to be published. The test has been approved as a point-of-care test in Canada for human diagnostics as an Interim Order European CE-IVD marked. In the US, FDA EUA is under evaluation. Detects SARS-CoV2 despite new variants of concern identified by WHO, ECDC, CDC - UK variant VOC 202012/01 - South Africa variant 501Y.V2 - Brazil variant 484 K.V2 - Indian variant B.1.617 - Californian variants B.1.429 and B.1.427 *Research Use Only - RUO (USA Only)