Introducing our Flu Multiplex PCR Kit – the ultimate solution for fast and accurate detection of Influenza A, Influenza B, and RSV in a single run. Our advanced technology utilizes the NP and M genes to identify Influenza A and B, resulting in double detection capabilities. Additionally, our kit utilizes the RNP sequence as a template for replication and transcription, allowing for quick and reliable detection of RSV. With two nuclear localization signals present in the NP sequence, our kit ensures active RNP import into the nucleus. Plus, the interaction of viral proteins with M1 enables the export of RNP, allowing for dual detection of Influenza A and Influenza B. Trust our Flu Multiplex PCR Kit to provide accurate and reliable results for all your flu detection needs.
Instructions for Use
Declaration of Conformity
Introducing our Flu Multiplex PCR Kit – the all-in-one solution for quick and accurate detection of Influenza A, Influenza B, and RSV in a single run. Influenza is a highly contagious virus that affects the upper respiratory tract, causing high fever, muscle aches, headache, cough, and sore throat, and in some cases, can lead to pneumonia or death, especially in individuals with pre-existing heart, kidney, or lung problems. RSV is a virus that mainly affects infants and children under the age of 1, causing bronchitis and pneumonia, with symptoms such as fever, cough, runny nose, and wheezing.
GeneProof’s Flu Multiplex PCR Kit detects and distinguishes Influenza A, Influenza B, and RSV in a single reaction tube, making it a highly efficient and time-saving solution for differential diagnostics of infectious agents causing flu and flu-like symptoms. It features a dual-target detection of Influenza A (NP gene/M gene) and Influenza B, and detects all currently known Influenza A serotypes, including H1N1, H1N1pdm09, H3N2, H5N8, and H7N, as well as both Influenza B lineages Victoria and Yamagata, and RSV A and RSV B, ensuring high specificity and accuracy.
Our kit is also designed to eliminate contamination, as it contains Uracil-DNA glycosylase (UNG) and dUTPs, which help eliminate contamination with amplification products. It is compatible with a wide range of real-time PCR devices and comes as a single-tube ready-to-use master mix, which contains all components for PCR amplification, eliminating the need for additional PCR reagents pipetting.
The Flu Multiplex PCR Kit is CE-IVD certified and is a WHO-recommended design, making it a reliable and trustworthy diagnostic test for flu and RSV detection. It is also beneficial when combined with the GeneProof SARS-CoV-2 PCR Kit or GeneProof SARS-CoV-2 Screening PCR Kit, making it a valuable tool for COVID-19 diagnosis and management. Trust our Flu Multiplex PCR Kit to provide accurate and reliable results for all your flu and RSV detection needs.
|Indication||in vitro diagnostic medical device|
|Regulatory Status||CE IVD|
|Intended User||For professional use in laboratories with trained staff|
|Type of Analysis||Qualitative|
|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 25.75 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
Qnostics, using manual extraction GeneProof PathogenFree RNA Isolation Kit)
reaches up to 161.64 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
Qnostics, using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
reaches up to 7.25 cp/μl with the probability of 95 % for Influenza B virus (on Amplirun® Influenza B RNA
reaches up to 43.57 cp/μl with the probability of 95 % for Respiratory syncytial virus (on Amplirun® RSV A RNA
|Diagnostic Specificity||100.00% (CI95%: 79.95%–100.00%)|
|Diagnostic Sensitivity||92.31% (CI95%: 80.60%–97.51%)|
|Extraction/Inhibition Control||PCR inhibition and RNA extraction efficiency control|
|Validated Specimen||Aspirate, BAL, swab, transport medium: Sigma MM*, Sigma Virocult*|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
|Instruments||ccroBEE Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
AriaMx Real-Time PCR System
LineGene 9600 Plus
|Required Detection Channels||FAM, HEX, Cy5, TexRed|
|External Quality Assessment||Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com|
* Only in combination with GeneProof PathogenFree RNA Isolation Kit