Viro-Plex Influenza RT-PCR Kit 5.0

Detect and Differentiate inf. (A, B, and H1N1)

The ViroGene Infl. A/B/H1N1 Kit is a multiplex reverse transcription–real-time polymerase chain reaction (RT-qPCR) in vitro diagnostic test for the separate qualitative detection and identification of influenza A and/or influenza B virus RNA and influenza H1N1 RNA purified from human nasal swab specimens.

The ViroGene Infl. A/B/ H1N1 Kit is intended for use as an aid in the differential diagnosis of viral upper respiratory tract infection in symptomatic patients when used in conjunction with other clinical and laboratory findings.

• 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 Influenza A virus, Influenza B virus, and Influenza A (H1N1) pdm09 virus 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.

  Two specific regions in the M gene and NP gene for the Influenza A virus

  two specific regions in the HA gene for the Influenza B virus

  Two specific regions in the M gene for Influenza A (H1N1) pdm09 virus  .

• 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

Technical specification

Technology	Real-time PCR
Type of Analysis	qualitative and quantitative
Target Sequence	Two specific regions in M gene and NP gene for Influenza A virus two specific regions in HA gene for Influenza B virus two specific regions in M gene for Influenza A (H1N1) pdm09 virus virus .
Analytical Specificity	Influenza A virus, Influenza B virus and Influenza A (H1N1) pdm09 virus 100 %
Analytical Sensitivity (LoD)	reaches up to 25.0 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control, Qnostics, using manual extraction RNA Isolation Kit) reaches up to 62.0 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control, Qnostics, using automatic extraction NA16 Nucleic Acid Extraction System) reaches up to 3.0 cp/μl with the probability of 95 % for Influenza B virus (on Amplirun® Influenza B RNA control, Vircell) reaches up to 3.0 cp/μl with the probability of 95 % for  Influenza A (H1N1) pdm09 virus virus (on Amplirun® RSV A RNA control, Vircell)
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, ROX and Cy5
External Quality Assessment	regularly tested by QCMD and Instand e.V. External Quality Assessment panels
Certification	CE IVD for in vitro Diagnostics Use