The novel SARS-CoV-2 (COVID-19) is a severe acute respiratory syndrome coronavirus that is responsible for respiratory disease and was first detected in Wuhan City, Hubei Province, China, and later caused a pandemic. world. The virus is contagious and is transmitted primarily through the exchange of mucus droplets expelled by sneezing or coughing. This outbreak is an important reminder that the global community must strengthen national and international programs to detect and respond to future disease outbreaks.
❖ Rapid detection of Novel SARS-CoV-2 (Covid-19) in around 1 hour
❖ No additional specialized instrumentation; tests performed on standard qPCR machines
❖ Low sample volume requirements
❖ Internal positive control to confirm that the quality of the RNA is acceptable for diagnostic tests
❖ Stable at -20°C for up to 18 months
The Zena Max SARS-CoV-2 Direct qPCR Assay System is a real-time PCR that enables the direct amplification of COVID-19 infection in human samples such as nasopharyngeal swabs (NPS), nasal swabs, nasal wash or aspirate or washes bronchoalveolar (BAL) using one-step RT-qPCR by first reverse transcription of 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′ reporter dye FAM™ and ROX with a 3′ quencher. As the new target cDNA strand is synthesized, the tightly bound probe is cleaved by the 5′ to 3′ exonuclease activity of Taq polymerase which releases the fluorescent tracer from the quencher and substantially increases the fluorescent signal. The point at which fluorescence becomes detectable above the background, the quantification cycle (Cq), is proportional to the amount of target present in the sample.
SARS CoV-2 (2019-nCoV) genomes are designed for in vitro detection of SARS COV-2 genomes. The lower the Cq, the greater the amount of target present. However, if SARS-CoV2 (COVID-19) is not present, a FAM signal or ROX signal will not occur. An internal positive control assay is provided to assess sample quality and the effect of any PCR inhibitors that may be present. This assay contains two primers and a HEX-labeled probe designed for a highly conserved region of human RNA, and a positive signal indicates that the quality of the RNA in the sample is acceptable for diagnostic testing.
These assays are incorporated into a ready-to-use PCR master mix that uses hot-start technology, minimizing 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. In silico analytical specificity shows that AMD SARS-CoV-2 analyzes 100% sequence identity in 769 of the 773 (99.4%) SARS-CoV-2 genomes available in public databases.