Ministerstvo Zdravotn Ctva Slovenskej Republiky Tender

Contract notice: Purchase of kits for RT - qPCR detection COVID-19. The subject of the contract is the purchase of 250 kits for RT-qPCR detection COVID-19 to perform about 250,000 reactions for SARS-CoV-2 detection. For SARS-CoV-2, at least 2 genome targets encoding key viral proteins should be used according to WHO recommendations, and at least one of the targets must be completely specific for SARS-CoV-2 in relation to other respiratory RNA viruses. The kit contains specific primers and probes for the detection of SARS-CoV-2 virus in qPCR reactions should meet the following: 1) kit with European certification for in vitro diagnostics - CE IVD / equivalent 2) kit designed for use on Real Time PCR instruments with fluorescence detection (eg BioRAD CFX, ThermoFisher ABI 7500, Roche Light Cycler 480 and similar) 3) TaqMan assay kit with fluorescence amplification detection; one-step essay required 4) The kit includes: - internal control to monitor the quality of the RT-PCR process (including synthetic) - quality control of collection and isolation through detection of the human gene - a positive control and a passive reference to control for fluorescence fluctuations 5) a kit allowing the addition of at least 5 (micro) L of test sample 6) detection limit at the level of min. 2 copies of the genome in response with a sensitivity of at least 95% kit with an expiration date of at least 12 months EUROPEAN UNION (EU),