NucleoGene COVID-19 MDA Detection Kıts
Purpose of Use

This test was developed to detect microorganism or anythings targets
from human, animal, food or environmental samples with simple, fast, high
specificity and precision. In the NucleoGene Molecular Detection Assay
(MDA) Kit method uses Circular Amplification Technology (CAT
METHOD), the amplification reaction at a constant temperature proceeds
under the isothermal condition. The reaction takes place at high
amplification efficiency with a plurality of 10 primers (all other different
from techniques) specific to the target gene region without the cycle, so
Real Time PCR (hydrolysis probes and hybridization methods) and
according to conventional PCR method is completed in less time. The
method has high tolerance to inhibitors, thus the human, animal, food and
environmental matrix effect is minimized. With its simple applicability, the
analysis is completed in 2 steps and in total a maximum of 45 minutes
(varies between kits). Amplification of these nucleic acids is carried out by
the CAT method using specific gene region-specific primers capable of
detecting all target. The presence of microorganism can be easily
determined by real-time monitoring of amplification curves in NucleoGene
Molecular Detection Assay Instrument. With the specially designed
NucleoGene Molecular Detection Instrument or the Real Time PCR (0,2
ml PCR tube or strip compatible), the results do not require
electrophoresis or any other method. All steps from amplification to
detection are carried out in a reaction tube. NucleoGene COVID-19 MDA Detection Kit is a real-time RT
amplificationbased detection system for the 2019 Wuhan coronavirus
(2019-nCoV). 2019-nCoV is considered a novel human coronavirus that is
genetically distinct from the common human coronaviruses (229E, NL63,
OC43, HKU1), which cause seasonal acute respiratory illness. It is also
genetically distinct from the two newer human coronaviruses, MERS-CoV
and SARS-CoV.

NucleoGene COVID-19 detects the presence of highly specific gene
sequences of 2019-nCoV: N gene. The assays must be tested positive to
confirm the sample as 2019-nCoV-positive. The first step in the detection
of 2019-nCoV is the conversion of viral RNA into cDNA. Afterwards, the
target sequences unique for 2019-nCoV are specifically amplified with
amplification monitored in real time through the use of fluorescently dye:
upon incorporation into the newly amplified DNA strands, the dye is
released and an in-crease in fluorescence signal can be observed. Due to
the intrinsic mutation rate of coronaviruses, it is possible that mutations in
the target sequence occur and accumulate over time. This can lead to
false-negative results with a PCR based detection approach. NucleoGene
COVID-19 addresses this issue by using N gene detection assays on 10
different target sequences to minimize the chance of false-negative results
causedby an altered target sequence. If samples are tested negative in
one or more assays, additional complementary testing maybe required.
Samples tested positive should always be confirmed through
complementary methods and additional analysis in an independent
laboratory

Purpose of Use
Supplied MaterialDescription96 Test
1Reaction StripsNucleoGene COVID-19 MDA
Reaction Mix
12 pieces
2Nucleic Acid Isolation TubesNucleic Acid Isolation Reagent Comprising Tubes96 pieces
3User ManualProcedure and Process Steps Descriptions1 piece
Nucleogene Covıd 19 MDA Detectıon System

Small foot print only 1kg calibration free for movement.

Portable device can be operated in biosafety cabinet

Battery pack and ready to use in rural area.

Less workload
• Not need centrifuge stage
• Not need reaction preparation
• Minimized contamination risk.

Fast result
• 48 sample in half an hour.

Precise result
• Specifity : %100-98
• Sensivity : 200-10 viral genom copy/ml

NucleoGene 2019 nCoV Multıplex RT qPCR Detectıon Kıt
Introduction

The first step in the detection of 2019 nCoV is the conversion of viral RNA into cDNA. Afterwards, the target sequences unique for 2019 nCoV are specifically amplified with amplification onitored in real time through the use of fluorescently labelled probes: upon incorporation into the newly amplified DNA strands, the fluorophore (FAM ™ Texas Red ™ Internal Positive Control)) is released and an increase in fluorescence signal can be observed. Due to the intrinsic mutation rate of coronaviruses, it is possible that mutations in the target sequence occur and accumulate over time. Thi s can lead to false negative results with a PCR based detecti on approach. NucleoGene 2019 n C o V addresses this issue by using 2 detection assays on 2 different target sequences to minimize the chance of false negative results caused by an altered target seq uence. If samples are tested negative in one or more assays, additional complementary testing may be required. Samples tested positive should always be confirmed through complementary methods and additional analysis in an independent laboratory.

QUANTITY AND VOLUMECOMPONENT
1 x 50 µlNucleoGene Enzyme Mix
1 x 10 00 µlNucleoGene 2X One Step RT qPCR Mastermix
1 x 4 50 µlNucleoGene 2019 nCoV Oligo Mix
2 x 1 mlNuclease free dH2O
DOCUMENTS
Nucleogene COVID 19 MDA DetectIon System
FEATURENucleoGene Circular Amplification TechnologyReal Time PCR Systems
Total Time (including nucleic acid isolation)30 min4-5 hours
Specificity%100-98 %100-85
Sensitivity*200-10 viral genom copy/ml*200-10 viral genom copy/ml
*101-102 bacterial cfu/ml*106-104 bacterial cfu/ml
Nucleic acid extraction5-10 min45-120 min
Centrifuge Stage No Yes
Reaction Preparation No Yes
Contamination RiskMinimizedHigh
Total solution transfer (including nucleic acid isolation) to complete analysis215 or more
Automatic analysis result dataYesNo
inhibition NoYes
Number of primers used102
Technique UsedCircular Amplification Technology TaqMan or others Probe
Qualified Staff Need NoYes
Shelf life1-2 year 0.5-1 year
Compatible with all Real Time PCRsYes (devices working with 0.2 ml tube)No
ValidationSynthetic genome or patient sampleSynthetic genome or patient sample
Device and required equipment costVery low (4500 euro)Very high (20-30 thousand euro)

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