Influenza A, B and RSV multiplex PCR kit

Manufacturer: 

Technical Features

Specifications:

• Target Sequence: specific region in M gene and NP gene for Influenza A virus/two specific regions in HA gene for Influenza B virus/specific region in M gene for Respiratory syncytial virus A and B
• Analytical Specificity: Influenza A virus, Influenza B virus and Respiratory syncytial virus A and B, 100 %
• Analytical Sensitivity (LoD): reaches up to 161.64 cp/ml for Influenza A  up to 7.25 cp/µl for Influenza B virus (on Amplirun® Influenza B RNA control)up to 43.57 cp/µl for Respiratory syncytial virus (on Amplirun® RSV A RNA control)
• Diagnostic Specificity 100.00% (CI95%: 79.95% – 100.00%)
• Diagnostic Sensitivity 92.31% (CI95%: 80.60% – 97.51%)
• Quality management system is certified in compliance with the requirements of the standard ISO 13485 ed.2:2016
• External Quality Assessment:  regularly tested by QCMD and Instand e.V. External Quality Assessment Panels
• Required Detection Channels FAM+ HEX + TexRed + Cy5
• Compatible  with a wide range of Real-time  PCR devices (LineGene 9600 Plus, Applied Biosystems 7300 / 7500 Real-Time PCR System, CFX96™/ Dx Real-Time PCR Detection System κα)
• Stable at -20 ± 5 °C
• The components are stable for a maximum of 3 repeated freezing / thawing cycles
• Regulatory Status CE IVD