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Multiplex RT-qPCR assay

CoviFlu™

A real-time RT-PCR assay intended for detecting nucleic acids from the SARS-CoV-2 virus and four of the most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2).

Specifications Details
Introduction of CoviFlu™

PentaBase’s CoviFlu™ Multiplex RT-qPCR diagnostic assay is a real-time RT (reverse transcriptase) PCR assay intended to detect nucleic acids from the SARS-CoV-2 virus and the four most common strains of influenza (B Yamagata, B Victoria, A H1N1, and A H3N2). SARS-CoV-2 and influenza RNA can be found in the liquid from infected individuals' upper or lower respiratory tracts. Samples can be obtained by nasopharyngeal or oropharyngeal swabs or from sputum.

The symptoms of SARS-CoV-2 have a lot in common with the symptoms of influenza, which can be difficult for physicians and clinicians to differentiate and diagnose correctly. PentaBase’s influenza COVID-19 multiplex RT-qPCR test is intended to identify the presence of the SARS-CoV-2 virus or influenza RNA by a fast and reliable method that rules out either COVID-19 or Influenza.

CoviFLU™ COVID-19 and Influenza Multiplex RT-qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.

Available in the following formats:

Dispense Ready (DR)

Ready-To-Use (RTU)

Instruction For Use


Targeted regions

SARS-CoV-2 IP2
SARS-CoV2 E

_________________________________________________________

Influenza A H1N1
Influenza A H3N2

_________________________________________________________

Influenza B Victoria
Influenza B Yamagata

_________________________________________________________

RNP



Description

RNA dependent RNA polymerase gene marker
Envelope protein gene marker

_________________________________________________________

Hemagglutinin gene marker
Hemagglutinin gene marker

_________________________________________________________

Hemagglutinin gene marker
Hemagglutinin gene marker

_________________________________________________________

Human RNase P (Internal Control)



Fluorophore

FAM
FAM

____________________________________________

HEX
HEX

____________________________________________

Cal Fluor Red 610
Cal Fluor Red 610

____________________________________________

Cy5

TECHNOLOGY AND REAGENTS

The CoviFlu™  Multiplex RT-qPCR assay combines real-time PCR with PentaBase’s novel and selective technologies comprising both standard synthetic oligonucleotides as well as proprietary modified synthetic oligonucleotides such as HydrolEasy™, EasyBeacon™ probes, and SuPrimers™ for specific and sensitive amplification.

The technology is applicable on standard real-time PCR equipment using standard procedures. Pentabase-modified oligos contain synthetic DNA analogues comprising a flat heteroaromatic, hydrophobic molecule and a linker. These modifications are inserted into the oligonucleotides at fixed positions during synthesis. Using the CoviFlu™ assay, the presence of virus RNA in a sample can be detected quickly, sensitively, and selectively by real-time RT-PCR analysis.

A tool for the detection of various influenzas

The symptoms of SARS-CoV-2 have a lot in common with the symptoms of influenza, which can be difficult for physicians and clinicians to differentiate and diagnose correctly. PentaBase’s influenza COVID-19 multiplex RT-qPCR test is intended to identify the presence of SARS-CoV-2 virus or influenza RNA by a fast and reliable method that rules out either COVID-19 or Influenza.

Other Assays

SARS-CoV-2 virus and the four most common strains of influenza

Nasopharyngeal or oropharyngeal swabs or from sputum

Highly sensitive and specific amplification

Designed to run on BaseTyper™ (PentaBase PCR instrument)

Specifications

Format
Multiplex
- HydrolEasy™ probe
- SuPrimers™
- EasyBeacon™
Product Variants
Ready-to-use (RTU) : 96 reactions
Dispense Ready (DR): 200 reactions
Targets
SARS-CoV-2 IP2
SARS-CoV-2 E
Influenza A H1N1
Influenza A H3N2
Influenza B Victoria
Influenza B Yamagata
RNP
Shipment
Dry ice or frozen ice bricks
Storage and Stability
Maximum -20°C (In original packaging)
Repeated thawing and freezing should be kept to a minimum.
Refer to the label for expiry date.
Result Time
>3 hours
Materials
Plasticware compatible with the used real-time PCR instrument
Pipettes (1-10 µL, 10-100 µL)
Pipette Tips
Centrifuge for spinning PCR tubes, strips or plates
Collection Kits
Oropharyngeal swab
Saliva collector
Sample Purification
RNA Extraction kit (E.g. Viral DNA and RNA Extraction Kit, PentaBase A/S, ref. no. 727)
Extraction instrument (E.g. BasePurifier™ 32 Nucleic Acid Extraction System, PentaBase A/S, ref. no. 715)
Extraction controls
Positive (20 copies/µL) and negative
Approved instruments
Real-time PCR instrument E.g. BaseTyper™ Real-Time PCR Instruments
CFX96/384 Touch Real-Time PCR Detection Systems
Bio-Rad, QuantStudio™ 5 Real-Time PCR System Applied Biosystems™
Result Analysis
Automatic and manual baseline and threshold settings
Approved Instruments for Use of CoviFlu™ Assay

PentaBase systems for CoviFlu™ Assay

CoviFlu™ Multiplex RT-qPCR assay is currently designed to run on BaseTyper™ (PentaBase PCR instrument). Additional instruments such as, CFX96/384 Touch Real-Time PCR Detection Systems (Bio-Rad), QuantStudio™ 5 Real-Time PCR System (Applied Biosystems™)

BaseTyper™ Real-time PCR Instrument
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