GenomeCoV19 Detection Kit - CE-marked (for IVD)

User Manual

Product Description

• SARS-CoV-2 detection in RNA isolated from naso- and oropharyngeal swabs
• Highly specific for ORF1ab (RdRP) and N targets recommended by WHO and US CDC
• Ready-to-use kit including MasterMix, Primers/Probes and Internal Positive Control
• Compatible with standard real-time PCR instruments (e.g. ABI 7500, Bio-Rad CFX96)
• Results ready in less than 2 hours
• CE-marked for IVD

The COVID-19 RT-PCR Rapid Detection Kit uses real-time RT-PCR fluorescence technology to specifically detect RNA-dependent RNA polymerase (RdRP; ROX) and nucleocapsid (N; FAM) genes from SARS-CoV-2 in human nasopharyngeal and oropharyngeal swab specimens. An internal control, human RNase P (RP; HEX), is included.

How it works

Detects the following variants of SARS-CoV-2:

Confirmed by in silico analysis

• Alpha/ UK variant B.1.1.7 defined by the following mutations of the virus's spike proteins: deletion of 69-70, deletion of 144, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H
• Beta/ South African variant B.1.351 defined by the following mutations of the virus’s spike proteins: L18F, D80A, D215G, R246I, K417N, E484K, N501Y and A701V
• Brazilian variant B.1.1.28 defined by the following mutations of the virus's spike proteins: L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, H655Y, T1027I
• Gamma/ Brazilian variant P.1 (a branch off B.1.1.28 lineage) defined by the following mutations of the virus's spike proteins: K417T, E484K, N501Y
• Delta/ Indian variant B.1.617.2 defined by the following mutations of the virus’s spike proteins: L452R, T478K, D614G, P681R, D950N, and deletion of 156 -157
• Delta Plus (a branch off B.1.617.2 lineage) defined by the following mutations of the virus’s spike proteins: L452R, T478K, D614G, P681R, D950N, deletion of 156 -157, K417N
• Omicron / Variant B.1.1.529 defined by the following mutations of the virus’s spike proteins: A67V, Δ69-70, T95I, G142D, Δ143-145, Δ211, L212I, ins214EPE, G339D, S371L, S373P, S375F, K417N, N440K, G446S, S477N, T478K, E484A, Q493K, G496S, Q498R, N501Y, Y505H, T547K, D614G, H655Y, N679K, P681H, N764K, D796Y, N856K, Q954H, N969K, L981F