Coronavirus disease 2019 (COVID 19) is caused by a severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) that was first detected in Wuhan City, Hubei Province, China. The virus is contagious and can be spread from human to human primarily through the exchange of mucus droplets that are expelled through sneezes or coughs.
This kit detects the presence of COVID-19 using one-step RT-qPCR (both reactions in the same tube) by first reverse transcribing the genomic RNA target to cDNA, followed by amplification of the assay target and detection by the hydrolysis probe method of qPCR. The assay consists of a forward primer, a reverse primer and a probe labelled with the 5’ FAM™ reporter dye and a 3’ quencher. As the new target cDNA strand is synthesised, the tightly bound probe is cleaved by the 5’ to 3’ exonuclease activity of Taq polymerase which releases the fluorescent reporter from the quencher and substantially increases the fluorescent signal. The point at which the fluorescence becomes detectable above the background, the quantification cycle (Cq), is proportional to the amount of target present in the sample. The lower the Cq, the greater the amount of target present. If, however Coronavirus 2019 COVID-19 is not present, a FAM signal will not be produced. An internal positive control assay is provided in order to assess the quality of the isolated RNA and the effect of any PCR inhibitors that may be present. This assay contains two primers and a HEX labelled probe, designed to a highly conserved region of human RNA and a positive signal indicates that the RNA quality in the sample is acceptable for diagnostic testing.These assays are both incorporated into a ready-to-use PCR master mix which utilises hot start technology, thus minimising non-specific reactions and ensuring maximum sensitivity. This in vitrodiagnostic kit provides qualitative detection.
Quality: All AMD kits manufactured under high quality standardization methods and unique precision and sensitive technology study compared by the most of famous and approved diagnostic commercial The Human ZIKA Virus RNA assays.
Sensitivity: AMD SARS-COV-2 Virus RNA kit is very sensitive kit reaches up to one copy “rxn volume 25ul” under our validation methods and devices.
Specificity: AMD Human SARS-COV-2 Virus RNA is very specific up to 100% for Human SARS-COV-2 Virus RNA under our validation methods and devices.