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)