ALS SARS-CoV-2 RT-PCR 4G
- CE-IVD marked
- Detection of ORF1ab, N and E genes (improved detection efficiency)
- Detection of human endogenous gene (full-process monitoring control)
- Inert plate loading dye to avoid pipetting errors
- Compatible with qPCR open platforms
- Detects the UK, Brazil and South Africa variants
ALS SARS-CoV-2 RT-PCR 4G has been developed and produced entirely at ALS in Portugal and is designed mainly for export. This new kit is able to detect all known SARS-CoV-2 variants, including British, Brazilian and South African variants, without cross-reacting with other known related viruses or common respiratory pathogens. The choice of the genomic regions used as targets and the sequences of the primers and hydrolysis probes were based on WHO, CDC and DGS recommendations.
The ALS SARS-CoV-2 RT-PCR 4G kit is an in vitro diagnostic medical device (CE-IVD) that uses real-time PCR nucleic acid amplification technology for the detection of SARS-CoV-2 in clinical samples from the upper respiratory tract of individuals who may or may not be suspected of having COVID-19.
The kit uses the RT-PCR technique, combining amplification of certain regions of the viral genome with its detection by specific hydrolysis probes. The SARS-CoV-2 genome target regions are highly conserved and correspond to two specific genes: ORF polyprotein (ORF1ab gene) and nucleocapsid phosphoprotein (N gene). The kit can also detect the gene that codifies the structural protein of the envelope (gene E) specific to the Sarbecovirus subgenus.
The kit also an endogenous control that makes it possible to monitor the quality and efficiency of the nucleic acid extraction step, the amplification process and the integrity of the kit reagents and the sample itself. All genes are amplified simultaneously in the same reaction mixture (multiplex) favouring greater detection efficiency. The ALS SARS-CoV-2 RT-PCR 4G kit can detect at least 2.5 copies/µL of SARS-CoV-2 RNA.
The kit must be used by properly trained health professionals and laboratory technicians with specific training in in vitro diagnostic medical devices, at clinical test laboratories or in hospital or clinical settings. Together with other relevant clinical and epidemiological data, the results of viral RNA detection in human samples help in the diagnosis of COVID-19.
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