Adenovirus Real Time PCR Kit

• 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 Adenovirus 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.

DETECTION OF ALL HUMAN ADENOVIRUS SPECIES

• The kit enables detection of Adenovirus respiratory species A–D, G and gastrointestinal species E-F

ASSURANCE BY NATIONAL REFERENCE LABORATORY

• Clinical performance was provided by The National Institute of Public Health (National Reference Laboratory for Influenza)

WIDE RANGE OF VALIDATED CLINICAL MATERIALS

• Validated specimen: aspirate, plasma, stool, swab, urine, whole blood

• Enables detection of both respiratory and gastrointestinal samples

Technology	Real-time PCR
Type of Analysis	qualitative and quantitative
Target Sequence	highly conservative DNA sequence of E2B gene
Analytical Specificity	Adenovirus, 100 %
Analytical Sensitivity (LoD)	reaches up to 30.1 cp/ml with the probability of 95 % (on AcroMetrixTM Adenovirus Plasma Panel using manual extraction Kit reaches up to 480.6 cp/ml with the probability of 95 % (on Qnostics ADV Molecular ‚Q' Panel using manual extraction DNA Isolation Kit)
Diagnostic Specificity	87.98 % (CI95%: 82.16% – 92.15%)
Diagnostic Sensitivity	100 % (CI95%: 91.11% – 100%)
Linear Range	1010 – 102.5 cp/ml with precision ± 0.5 log (using AcroMetrix™ Adenovirus Plasma Panel) 1010 – 5x103 cp/ml with precision ± 0.5 log (using Qnostics ADV Molecular ‚Q 'Panel)
Dynamic Range	1010 – 81.41 cp/ml (using AcroMetrix™ Adenovirus Plasma Panel) 1010 – 2371.645 cp/ml (using Qnostics ADV Molecular 'Q 'Panel)
Reporting Units	cp/μl
Metrological Traceability	Qnostics ADV Molecular ‚Q 'Panel
Extraction / Inhibition Control	PCR inhibition and DNA extraction efficiency control
Validated Specimen	plasma, stool*, swab, urine, whole blood * only in combination with QIAamp DNA stool Mini Kit
Storage	-20 ± 5 °C
Validated Extraction Method	ViroGene Viral RNA/DNA Extraction Kit & 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™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System
Required Detection Channels	FAM, HEX
External Quality Assessment	regularly tested by QCMD and Instand e.V. External Quality Assessment panels
Certification	CE IVD