gb SARS-CoV-2 Combi
one-step real-time PCR
Combi CE IVD kit for detection of SARS-CoV-2 virus is based on one-step RT-qPCR using fluorescently labelled probes which allow the detection of viral genes E and RdRP in FAM channel and external positive control in HEX channel. The detection method is based on officially recommended WHO and Institute Pasteur designs for detection of SARS-Cov-2 and usage of our proprietary GEMINI™ probe technology.
– CE IVD one-step RT-qPCR kit
– combi assay targeting the viral E gene and RdRP genes in FAM channel and the External Positive Control in HEX channel
– the kit includes Master Mix OneStep Multi, Positive Control CoV-2, EPC Template RNA and Deionized Water
– Positive Control CoV-2 serves for a verification of the analysis validity
– EPC Template RNA is an external positive control for verification of the isolation process
– GEMINI™ probe technology results in high sensitivity of detection and lower background
– LOD of combi assay is 3,45 copies of viral RNA per reaction (95% CI)
– the kit contains all the necessary components to perform the test
– suitable for two channel PCR thermocyclers
– identical temperature profile for all SARS-CoV-2 detection kits
– analysis preparation scheme
Prevention of false negative results
In the kit, control of both RNA extraction step and PCR process is provided by detection of external RNA in HEX channel after spiking the samples with the external RNA prior to the extraction.
In addition to this generally used protocol, the labs that demand a verification of the sampling step can use our gb Human B2M mRNA kit
. The kit is based on the detection of transcripts of B2M gene, a human reference gene ubiquitously present in all human samples. If the human reference transcript is not detected, the sample was not taken properly.