1copy™ COVID-19 qPCR 4plex Kit

About 1copy™ COVID-19 qPCR 4plex

1copy™ COVID-19 qPCR 4plex Kit is a real-time qPCR kit that detects RdRp gene, E gene, and N gene in a single tube to diagnose COVID-19 in specimens obtained from nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab and oropharyngeal swab as well as nasopharyngeal wash/aspirate and nasal aspirate. It is a multiplex qPCR kit that can identify 3 target genes in a single tube and detect the virus in just 50 minutes. Internal positive control (IPC) of 1copy™ COVID-19 qPCR 4plex 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 qPCR 4plex 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.

The package of 1copy™ COVID-19 qPCR 4plex Kit

For more details,
feel free to download
our following materials

User
manual
EC
certificate
Quick
guide

Kit components
(100 rxns/box)

The reagents included in one COVID-19 qPCR 4plex kit are sufficient for testing 100 samples.

Components

Master Mix
Prime Probe mix*
Control*
DEPC Water

Container color

Red
Brown (Amber tube)
Yellow
Clear

Volume

1000µl
100µl
100µl
1000µl

*(RdRp gene, E gene, N gene, IPC)

Accuracy of over 95%

Single-step testing without RNA extraction allows the speed of a rapid test. Results are displayed directly onto the user’s mobile smart device via 1POT App.

Type LoD (copies/rxn)
RT-PCR(Standard) 5-50
1copy™ COVID-19 MDx Kit Professional 100
Antigen Rapid 10,000~100,000

Visible Detection

Instead of detecting fluorescence emission with an extra detection instrument, our test simplifies the detection process by measuring visible light with naked eyes and mobile applications.

1POT™ Professional

Device

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.

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

Product Specification

Test Step

Limit of Detection(LoD)

Target

Testing time

Sample

Test item

Single Step
5 copies/reaction (400copies/mL)
E, N, RdRp
50 mins
Total RNA (cropharyngeal sample)
COVID-19

Test procedure

Specimen collection

Nucleic acid (RNA) isolation

Amplification

Data analysis

Report results

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Acceptance

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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