Duplex kits for SARS-CoV-2 gb detection SARS-CoV-2 N (100 pcs)
– one-step RT-qPCR method based on WHO protocols, detection of N / E genes (primary tests) and RdRP / N (confirmatory tests)
– the choice of a specific kit for the primary and confirmatory test is up to the preferences of the laboratory
– Duplex design for higher sensitivity and lower risk of contamination
– target gene in FAM channel, internal positive control (PCR inhibition control) in HEX channel
– GEMINI ond probe technology providing lower background and high detection sensitivity
– to control the process of RNA collection and extraction from the sample, a pair of kits can be supplemented with a kit for the detection of human RNA gb Human B2M mRNA kit
– in case of contamination with PCR products, the laboratory can immediately switch to an alternative primary and confirmation kit
– LOD assays less than 3 copies of viral RNA per reaction (95% CI)
– identical temperature profile for all kits
Primary test kits (gb Sarbeco N, gb Sarbeco E) based on the detection of the N gene (or E gene) of the virus are intended for primary testing of all samples. Assay kits target conserved Sarbecovirus sequences.
Confirmatory test kits (gb SARS-CoV-2 RdRP, gb SARS-CoV-2 N) based on the detection of the viral RdRP gene (resp. N gene) are recommended to confirm positive samples from the primary test. Assay kits target SARS-CoV-2 specific sequences.
Detailed kit description:
– the detection method is one-step RT-qPCR – the microtubes do not open during the whole test
– a system of two consecutive duplex tests ensures high sensitivity of both tests
– each CE IVD kit contains components:
– specific qPCR Assay – includes internal positive control (IPC)
– OneStep Master Mix
– positive control
– negative control
– the reaction mixture is prepared by mixing two kit components + biological sample (scheme here). The kits contain all the components to perform one-step RT-qPCR detection of viral RNA.
– all kits have a FAM detection system and HEX internal positive control (IPC), so they are also compatible with two-channel thermal cyclers
– FAM probes of both kits are modified with GEMINI technologií technology, which increases the sensitivity and specificity of detection
– all kits have the same amplification profiles
– LOD assay is less than 3 copies (determined by probit analysis, 95% confidence level) of viral RNA in each reaction (such sensitivity corresponds to the theoretical minimum achievable by PCR methods)
RNA sample quality:
Laboratories that need to verify the quality of the analyzed samples to prevent false negative results can use our gb Human B2M mRNA kit. The kit ensures that the swab samples have been taken correctly and that the RNA extraction method used is reliable. The kit uses the detection of the B2M gene transcript, which is the human reference gene present in all human samples. The whole preanalytical process is checked using the gb Human B2M mRNA kit. If a sample deviates from the series (or the reference gene is not detected at all), a new RNA collection and / or isolation and a new test are required.
Consumption of each kit:
At the beginning of testing with both kits, we recommend that you order both kits in a 5: 1 ratio (500 rxn primary test: 100 rxn confirmation test). The ratio for subsequent orders can be adjusted according to the expected ratio of positive patterns (10: 1 to 20: 1 or even less).
Backup solution in case of contamination:
Although the microtubes with the reaction mixture after PCR should not be opened in the laboratory under any circumstances, contamination may occur by accident, especially if the laboratory is in high throughput testing mode. If this happens, the kits used can no longer be used due to false positivity.
For an easy solution to this crisis scenario, we recommend using only one type of primary test and one type of confirmatory test. If contamination occurs, you will immediately switch from the currently used pair of kits to the second pair of kits not in use yet.