ViroGene MERS-CoV RT-PCR Kit 1.0

• 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 MERS-CoV 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 more than 35 assays 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 calibration and QC at no Extra cost.

• All Kit Components are stable at 2 – 8 C until Expiry Date with no effect on their stability or performance.

Technology	Real-time PCR
Type of Analysis	Qualitative and quantitative
Target Sequence	Two specific regions in E gene(upE) and open reading frame 1a (orf1a) for MERS CoV
Analytical Specificity	MERS CoV 100 %
Analytical Sensitivity (LoD)	Reaches up to 2.0 cp/μl with the probability of 95 % for MERS CoV
Diagnostic Specificity	100.00% (CI95%: 79.95%–100.00%)
Diagnostic Sensitivity	96.5% (CI95%: 80.60%–97.51%)
Reporting Units	cp/μl
Extraction / Inhibition Control	PCR inhibition and DNA extraction efficiency control
Validated Specimen	PBS, Saline, aspirate, BAL, swab, transport medium: Sigma MM*, Sigma Virocult*
Storage	-20 ± 5 °C
Validated Extraction Method	ViroGene Viral RNA/DNA Extraction Kit & NA16 MagCore NA Extractor
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™ 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System
Required Detection Channels	FAM, HEX and ROX
External Quality Assessment	regularly tested by QCMD and Instand e.V. External Quality Assessment panels
Certification	CE IVD for in vitro Diagnostics Use