gb SARS-CoV-2 Influenza A/B
one-step real-time PCR
gb SARS-CoV-2 Influenza A/B CE IVD kit is based on one-step RT-qPCR using fluorescently labelled probes enabling a multiplex detection of viral genes of SARS-CoV-2, Influenza A and Influenza B. The detection method is based on officially recommended WHO and Institut Pasteur designs for detection of SARS-CoV-2 and on usage of our proprietary GEMINI™ probe technology.
– CE IVD one-step RT-qPCR kit
– CoV-2 Influenza multiplex assay targeting viral genes SARS-CoV-2 (E, RdRP genes – FAM channel), Influenza A (HEX channel), Influenza B (ROX channel) and the exogenous positive control EPC (Cy5 channel)
– the kit includes Master Mix OneStep Multi, Positive Control CoV-2, Positive Control Influenza A, Positive Control Influenza B, EPC Template RNA and Deionized Water
– Positive Control CoV-2/Influenza A/Influenza B serves for the analysis validity verification
– EPC Template RNA is an exogenous positive control for verification of the isolation process and one-step RT-qPCR reaction
– GEMINI™ probe technology results in high sensitivity of detection and lower background
– LOD of CoV-2 Influenza multiplex assay is 2.15 cop/rxn for SARS-CoV-2, 14.68 cop/rxn for Influenza A and 10.67 cop/rxn for Influenza B (on 95% CI)
– the kit contains all the necessary components to perform the test
– analysis preparation scheme
Prevention of false negative results
In the kit, a control of the RNA extraction step and the PCR process is provided by detection of external RNA in Cy5 channel after spiking samples with the EPC Template 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 gene transcript is not detected, the sample was not taken properly.