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HMPV 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 human metapneumovirus (hMPV) specific RNA 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

One-Step real-time PCR

Type of Analysis

Qualitative

Target Sequence

Conservative region of N Gene

Analytical Specificity

Human metapneumovirus (hMPV) specific RNA 100 %

Analytical Sensitivity (LoD)

Reaches up to 10 cp/ul with the probability of 95 %

Diagnostic Specificity

100 % (CI95 % : 99.07 % - 100 %)

Diagnostic Sensitivity

100 % (CI95 % : 95.39 % - 100 %)

Linear Range

108 – 10 cp/ul with precision of ± 0.5 log (using manual extraction DNA Isolation Kit or automatic extraction NA16 Nucleic Acid Extraction System)

Dynamic Range

108.5 – 10  cp/ul  (using manual extraction RNA Isolation Kit)
10
8.5 – 8  cp/ul  (using automatic extractor NA16 Nucleic Acid Extraction System)
10
8.5 – 8  cp/ul  (using automatic extractor MagCore Automated NA Extractor)

Reporting Units

cp/ul

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

Light Cycler® 2.0 / 480

 Line Gene 9600 / 9600 Plus

Quant Studio™ 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

CE1023 IVD for in vitro Diagnostic Use