Multiplex kit for detection of SARS-CoV-2
one-step real-time PCR
Multiplex CE IVD kit for detection of SARS-CoV-2 virus is based on one-step RT-qPCR using fluorescently labelled probes (FAM and HEX channels) and external positive control (Cy5 channel). The detection method is based on officially recommended WHO and Institut Pasteur designs for detection of SARS-Cov-2 and usage of our proprietary GEMINI™ probe technology.
– CE IVD one-step RT-qPCR kit
– multiplex assay targeting the viral E gene (FAM channel), the viral RdRP gene (HEX channel) and the External Positive Control (Cy5 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 multiplex assay is 2,13 copies of viral RNA per reaction (95% CI)
– the kit contains all the necessary components to perform the test
– 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 Cy5 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.