1copy™ COVID-19/FluA/FluB/RSV qPCR Kit

About 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit

1copy™ COVID-19/FluA/FluB/RSV qPCR Kit is a real-time qPCR kit that detects N gene, RdRp gene, Flu A/B, and RSV in a single tube for the simultaneous diagnosis of COVID-19 and viral respiratory infections. As a multiplex qPCR kit that can identify 5 types of target genes in one tube, it can detect various respiratory viruses within 50 minutes. Internal positive control (IPC) of 1copy™ COVID-19 qPCR COVID-19/FluA/FluB/RSV qPCR Kit is extracted from the RNA of human GAPDH along with the target gene and is very effective in validating the quality of each step of the process (sample collection, RNA extraction, and amplification). 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Kit components
(100 rxns/box)

The reagents included in one COVID-19/FluA/FluB/RSV qPCR Kit are sufficient for testing 100 samples.

Components

Master Mix
Primer Probe mix1*
Primer Probe mix2*
Control**
DEPC Water

Container color

Red
Brown (Amber tube)
Brown (Amber tube)
Yellow
Clear

Volume

1000µl
100µl
100µl
100µl
1000µl

*  COVID19, FluA, FluB, RSV, IPC
**RdRp gene, E gene, N gene, IPC

For more details,
feel free to download
our following materials

User
manual
EC
certificate

Quick
guide

Clinical
evaluation

Innovation of 1copy™
 COVID-19/FluA/FluB/RSV qPCR Kit

Examine 4 pathogens in 1 tube

1copy™ COVID-19/FluA/FluB/RSV qPCR kit detects for COVID-19, Influenza A, Influenza B and RSV in a single tube.

Different viral infections require specific types of treatment. Inappropriate medical care can negatively affect a patient’s health. Therefore, differential diagnosis is crucial in identifying the exact cause of the symptoms in order to apply the right medical treatment.

Improving productivity with reduced cost

1copy™ COVID-19/FluA/FluB/RSV qPCR kit tests simultaneously in reduced running time with minimum labor required, it enables reduction of test cost and improve test productivity.

Outstanding LoD and Accuracy

LoD means Limit of detection, which is defined as the lowest concentration of an analyte in a sample that can be consistently detected with a stated probability.

The LoD of 1 copy simultaneous detection kit is five copies/reaction for COVID-19, and ten copies/reaction for FluA, FluB, and RSV. Thanks to this low LoD and the high accuracy, the specificity, and the sensitivity are 100%.

Room temperature shipping

Our freeze drying technology allows stable storage and transport of products at room temperature without any freezer, refrigerator or cold chain services. (Delivery by sea available. E.g. 87% decrease in cost for delivery of 300 kg by air from Korea to Frankfurt.)

NO Freezer &
Refrigerator

NO Dry Ice

NO Cold Chain

Strengths

Fast

1copyTM COVID-19/FluA/FluB/RSV qPCR kit tests simultaneously in reduced running time with minimum labor required, it enables reduction of test cost and improves test productivity.

Economical

Internal positive control (IPC) can be detected in one reaction with pathogens, making the laboratory more cost-effective and environmentally friendly.

Outstanding LoD

Five copies/reaction for COVID-19, and ten copies/reaction for FluA, FluB, and RSV.  

Fully certified

Products have been certified by CE-IVD and under registration by OGYÉI.

Isolations

According to the method of blood separation and isolation of targeted particles, different cartridges are provided.

Product Specification

Test Step

Limit of Detection(LoD)

Target

Testing time

Sample

Test item

Single Step
SARS-CoV-2 N, RdRp gene: 5 copies/rxn
Flu A/Flu B: 10 copies/rxn
RSV: 10 copies/rxn
SARS-CoV-2, Flu A, Flu B, RSV
50 mins
oropharyngeal sample,
nasopharyngeal sample
COVID-19 / Flu A / Flu B / RSV

Short Turn-around Time

All PCR running processes take only 50 minutes which can dramatically increase the number of specimens up to 846 per day.

846 specimens
per day with 1 PCR machine

50 minutes
Single step

Test procedure

Specimen collection

Nucleic acid (RNA) isolation

Amplification

Data analysis

Report results

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Dimension 85.0 X 59.2 X 70.3mm
Weight 220g
Connection Buletooth 5.0
Interface Testing with device and mobile App
Battery 6500mAH (8tests/ full charge, USB-C)
Testing condition Heat up to 55-65℃ from room temp (20-25℃) within 5 min.
Operating temp. 15~35℃
Operating humidity 10~90%RH

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