SARS CoV-2 Direct Confirm Plus Real Time PCR Kit

For rapid and high-frequency PCR-based SARS-CoV-2 detection

• Sample preparation and detection steps integrated into one single kit
• Sample preparation in 5 minutes
• End-to-end liquid-based workflow for full automation on liquid handlers
• Compatibility with Virtually any Transport Medium
• Includes inhibition control for reliable interpretation of results
• Contamination prevention using UDG enzyme.
• From sample processing to results 1 hour and 30 minutes based on instrument Ramping Rate.

The ViroGene SARS CoV-2 Direct Confirm Plus Kit is an innovative liquid-based approach to viral RNA epidemiology. The kit is optimized for ultrafast sample preparation and sensitive real-time PCR detection of enveloped RNA viruses such as coronaviruses from human samples (nasal, oro- and nasopharyngeal swabs) collected in non-fixation transport media like UTM, VTM, PBS, 0.9% NaCl, Virocult and eSwab. Fewer and simpler workflow steps accelerate the turnaround time and increase testing frequency while decreasing plastic usage, cost and hands-on time. The method can be seamlessly integrated into automated workflows with standard lab equipment at all throughput needs.

• Dual Probe Assay

The highly mutable nature of pathogens often proves challenging in molecular assay design. Traditional qPCR assays are designed so that a single primer and probe set targets one location within the pathogen genome. However, these single-target assays often prove inadequate to detect and quantify viral targets. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, ViroGene SARS CoV-2 Direct Confirm RT-qPCR assay targets two regions within the pathogen genome, utilizing unique primer and probe sets for each target site. The driving principle behind our multiple-target assay design is that when a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen, and thus reduces the likelihood of under-quantification or a false negative result.

• All kit Components are Liquid Ready to use with enhanced freeze thaw stability (> 30 times)

• Using the highest standards for choice of enzymes on our kits which can tolerates all types of inhibitors found usually in clinical samples with no effect on result quality

• Common Internal control for Respiratory Panel Kit to ensure ease of use with limited samples resources

• Common Reagents and common protocols which ensures running more than one test type on the same run

• Kit components enough to perform 110 Tests, to perform QC at no Extra cost

Item Name	SARS CoV-2 Direct Confirm Plus
Technology	One step RT real-time PCR
Type of Analysis	Qualitative
Target Sequence	Specific region in RdRp gene and S gene
Specificity	SARS-CoV-2, 100 %
Sensitivity (LoD)	Reaches up to 2.0 copy/ul with probability of 95 % (on COVID SCREEN program)
Extraction/Inhibition Control	Exogenous Internal Control
Validated Specimen	Swab in transport medium (VTM, UTM, PBS and Saline)
Storage	-20 ± 5 °C
Validated Extraction Method	ViroGene Direct Lysis Buffer
Validated Instruments	Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus QuantStudio™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System
Required Detection Channels	FAM, VIC
Certification	CE IVD