1copy™ COVID-19 MDx Kit Professional

About 1copy™ COVID-19 MDx Kit Professional

 

1copy™ COVID-19 MDx Kit Professional is a portable and compact device with the power of lab-quality molecular testing that can be used in hospitals, schools, logistics centers, and many other crowded places. In particular, health professionals are doing their best to care for both symptomatic and asymptomatic patients in this era of the COVID-19 pandemic.
They are consistently exposed to danger and should be protected against COVID-19. 1copy™ COVID-19 MDx Kit Professional offers convenience with an easy-to-use process and makes it possible for frequent testing.

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our following materials

IVD Export

Authorization by KFDA

Quick start

guide

Download

E-catalogue

CE Mark

Certification

The four benefits
of 1copy™ COVID-19 MDx

Our easy-to-use, innovative COVID-19 diagnostic device is a smart solution for health protection against the pandemic.

Get results in 22 minutes

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.

Isolations

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

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

RT-PCR(Standard)
1copy™ COVID-19 MDx Kit Professional
Antigen Rapid

LoD (copies/rxn)

5-50
100
10,000~100,000

Isolations

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

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

Isolations

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

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

Isolations

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

Comparison of
Diagnostic Performance

While the standard diagnostic methods with gene amplification provide highly accurate results, it takes 2 to 3 hours to complete testing.
Rapid antigen tests are faster due to gene amplification elimination but cannot diagnose low viral load samples or samples from early-stage patients.
1copy™ COVID-19 MDx Kit Professional is a novel molecular-based COVID-19 diagnostic platform that offers high accuracy and speed.

Type

Molecular Test

1copy™ COVID-19 MDx Kit Professional (Isothermal PCR)

Standart test

RT-PCR

Rapid test

Antigen test

Intended use

Molecular Test

Detection of virus (viral test): test for current infection

Standart test

Detection of virus (viral test) : test for current infection

Rapid test

Detection of virus (viral test) : test for current infection

Sample

Molecular Test

Nasal and/or nasopharyngeal, Oral and/or oropharyngeal

Standart test

Nasal and/or nasopharyngeal, Oral and/or oropharyngeal

Rapid test

Nasal and/or nasopharyngeal, Oral and/or oropharyngeal

Target

Molecular Test

Viral RNA

Standart test

Viral RNA

Rapid test

Specific viral antigen

Limit of Detection (LoD)

Molecular Test

100 copies/rxn

Standart test

5 - 500 copies/rxn

Rapid test

10,000 - 100,000 copies/rxn

RNA extraction time

Molecular Test

X

Standart test

0 (30min ~ 1h 30min)

Rapid test

N/A

Turn around time

Molecular Test

22 min

Standart test

1h 30min

Rapid test

15 min ~ 30 min

Total time

Molecular Test

22. min

Standart test

2h ~ 3h

Rapid test

15 min ~ 30 min

Reagent storage temp.

Molecular Test

Room temp.

Standart test

Frozen (Below -20℃)

Rapid test

Room temp.

Optical detection

Molecular Test

Visible

Standart test

Fluorescence

Rapid test

Visible

Detection chemistry

Molecular Test

Loop-mediated isothermal amplification Gene amplification to detect presence of virus

Standart test

RT-PCR amplification Gene amplification to detect presence of virus

Rapid test

Serology test Visualization of antibody accumulation in sample to detect presence of virus

Product Specifications

Target gene

Limit of Detection(LoD)

Test item

Detection chemistry

Reagent state

Sample

Shelf life

N, S
100 copies/rxn
22 mins
Isothermal amplification
Solid
Viral materials from nasopharynx
6 months at room temp.

Dimension

Weight

Connection

Interface

Battery

Testing condition

Operating temp.

Operating humidity

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

Simple Testing Steps

Use a swab to collect sample

Place fab in tube containing reagents and mix 15 times

Drop mixed sample into each test tube

Place test tubes into 1POT device

Check results on smartphone after 22 minutes

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Acceptance

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