Zena Max – AMD SARS-COV-2 Direct q-PCR Detection Kit CE-IVD
SARS-CoV-2 (COVID-19) is the virus responsible for respiratory disease caused by a novel (new) coronavirus that was first detected in Wuhan City, Hubei Province, China, later causing a global pandemic. 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.
The SARS-CoV-2 is a severe acute respiratory syndrome coronavirus. 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 (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™ 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 primers and probe sets target two different target regions the ORF1ab gene and N gene which had previously been used in the identification of the SARS coronavirus, however, there is no cross-reactivity with this or any other coronavirus sequenced thus far.
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.
This in Vitro diagnostic kit provides qualitative detection.
Quality: All AMD kits are manufactured under high-quality standard methods and unique precision, compared with other leading commercial SARS-CoV-2 diagnostic kits.
Sensitivity: The Zena Max COVID-19 qPCR kit is highly sensitive, able to detect a minimum of 10 copies per reaction under our validation methods and devices.
Specificity: The analytical specificity study was carried out by in silico analysis 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, however, there is no cross-reactivity with any other coronavirus sequenced or the most common respiratory pathogens thus far.
|Product name||Technology||Package||Catalogue No|
|AMD Human SARS-CoV-2 Direct detection kit||One step Real time PCR||100 reactions||KD145906D-100|