Zena Max – AMD SARS-COV-2
Direct q-PCR Detection Kit CE-IVD
❖ Rapid detection of the Novel SARS-CoV-2 (Covid-19) in around 1 hour
❖ No additional specialist instrumentation; testing carried out on standard qPCR machines
❖ Low sample volume requirements
❖ Internal positive control to confirm RNA quality is acceptable for diagnostic testing
❖ Stable at -20 °C for up to 18 months
|Product name||Technology||Package||Catalogue No|
|AMD Human SARS-CoV-2 Direct qPCR detection kit||One step Real time PCR||100 reactions||KD145906D-100|
|AMD Human SARS-CoV-2 Direct qPCR detection kit||One step Real time PCR||600 reactions||KD145906D-600|
The novel SARS-CoV-2 (COVID-19) is a severe acute respiratory syndrome coronavirus which is responsible for respiratory disease was first detected in Wuhan City, Hubei Province, China, later causing a global pandemic. The virus is contagious and is spread primarily through the exchange of mucus droplets that are expelled through sneezes or coughs.
This outbreak is an important reminder that the global community must strengthen national and international programs for detection and response to future disease outbreaks.
Zena Max SARS-CoV-2 Direct qPCR assay system is a RealTime PCR that enables the direct amplification of COVID-19 infection in human samples like nasopharyngeal swabs (NPS), nasal swabs, nasal wash or aspirate or bronchoalveolar lavage (BAL) using one-step RT-qPCR 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™ and ROX reporter dye with 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 SARS CoV-2 (2019-nCoV) genomes are designed for the in vitro detection of SARS COV-2 genomes. The lower the Cq, the greater the amount of target present. If, however, SARS-CoV2 (COVID-19) is not present, a FAM signal or ROX signal will not be produced. An internal positive control assay is provided in order to assess the quality of the sample 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.
The Zena Max COVID-19 direct qPCR kit is sensitive down to a minimum of 10 copies per reaction. The analytical specificity in silico shows that the AMD SARS-CoV-2 assays 100% sequence identity to 769 out of the 773 (99.4%) SARS-CoV-2 genomes available in the public databases.
For further information, please see our Instructions for Use