VEUDx
Overview
New IVD system Efficient multiplexed POCT diagnostic technology
VEUS is a fully automated ALL-IN-ONE diagnostic system for rapid and accurate immunoassays and molecular diagnostics within 15~50 minutes.
Conventional immunoassays such as Enzyme-linked Immunosorbent assay (ELISA), Fluorescence Immunoassay (FIA) and Chemiluminescence Immunoassay (CLIA) are used as precision immunoassays, but require 3~4 hours per test. In molecular diagnostics, it takes 4~6 hours from nucleic acid extraction to result analysis.
Further, such processes involve expensive equipment and professional manpower to perform tests, and are, therefore, not suitable for the point-of-care testing environment.
VEUS, the abbreviation of Versatile, Easy, and User-friendly System, is a diagnostic system: Versatile – almost all in vitro diagnostic items are applicable; Easy – the system entirely automated enabling easy testing with no pretreatment required; User-friendly – anybody can use the system easily. Further, the system realizes high sensitivity (below 1 pg/ml), multiplexed diagnostics(simultaneous testing of several biomarkers), rapid results (within 15~50 minutes) with high accuracy (above 95%).
Features
-
No warming time
With no warming time required, the system enables immediate testing as it can reach 37°C within 3~4 min., shortening the preparation time for testing.
-
Efficient mixing / washing
The up&down/well to well movement technology of magnetic particles makes reaction and washing easy and reduces both generation of wastes and automatic device size, enabling economical and eco-friendly use.
-
Multiplex assay
Based on the magnetic particle size-based coding system, the VEUS system allows multiplexed diagnostics.
-
ALL IN ONE system
With the reaction and optical modules integrated as a unit, the VEUS system allows easy operation.
Technical principle
Four differentiated technologies of VEUS
We have developed the world’s first diagnostic product that provides hypersensitive and high-accuracy diagnoses in 15~50 minutes.
Rapid reaction
technology
The VEUS technology can perform rapid and hypersensitive diagnosis by moving magnetic particles up & down and well to well. Further, the VEUS technology has been recognized with several granted patents for simultaneous heating and mixing, which results in reduction of reaction time and cost.
RSMP (Rod Shaped Magnetic Particles)
Our own ingenious magnetic particles contain excellent surface uniformity to avoid non-specific binding and enable multiplex assays with various lengths of RSMP.
Ultrasensitive fluorescence detection technology
EzDiatech’s own unique technology enabling detection of fluorescent signals below 1 pg/ml, with the image module’s Field of View at above 50mm², which increases time efficiency.
AI multiplex analysis technology
Our own unique technology with the dispersion module and the AI program enables the multiplexed image analysis efficiently.
with outstanding performance and reproducibility
Overview
Rod Shaped Magnetic Particles - RSMP
Magnetic particles are usually used in the current IVD field to derive quick and accurate diagnostic results. However, conventional magnetic particles, with low reproducibility and availability, have a drawback to require expensive imaging system.
To solve this problem, we have developed an original magnetic particle, Rod Shape Magnetic Particles (RSMP) that can be used for multiplexed diagnostics with high reproducibility and low production cost.
Features
RSMP has superior strengths in all aspects such as productivity, reproducibility, precision results, availability and cost compared to conventional magnetic beads.
Outstanding surface
uniformity
Optimization for
multiplexed assays
Excellent
availability
Affordable
production cost
Performance
Multiplexed assays are possible with economical costs by establishing a manufacturing process that can create various lengths of RSMP.
1 RSMP structure
2 Multi-diagnosis principle of RSMP
3 VEUPLEX™ TBI assay - application case for multiplexed assays
It is possible to apply various functional groups including carboxyl groups to the glass surface through excellent usability and optimization of the magnetic particle surface. Therefore, it can bind antibodies, proteins, DNA, etc., so it can be applied to various fields as well as immune diagnosis and molecular diagnosis.
Surface uniformity is very important to detect ultra-low concentration biomarkers. EzDiatech's RSMP maximizes the concentration of antibodies through chemical surface treatment, so accurate results can be identified, and this technology is protected by a patent.
* Patent registration : 10-2341666 (2021.12.16)
| RSMP |
|---|
|
| Ultra-low concentration substances can be detected |
| Possible for Multiple diagnosis |
| High reproducibility and result accuracy |
| Conventional Magnetic Particles |
|---|
|
| Difficulty in detecting ultra-low concentration substances |
| Difficulty in multiple diagnosis |
| Moderate Accuracy |
Overview
Magnetic Particle Moving Reaction Technology
Existing immunochemical reactions use a method of exchanging liquids such as reaction solution and washing solution with magnetic particles remaining in the well, so there are various disadvantages such as accuracy and reproducibility of results, time and cost.
VEUS overcomes the shortcomings with a rapid response technology using RSMP to which an antibody is bound and can confirm the diagnosis result within 15~50 minutes.
Features
The rapid reaction and washing technology through RSMP’s up & down /well to well movement can reduce running time for diagnosis, experimental waste and device size.
Maximize
cleaning effect
Minimize diagnosis time
within 15~50 minutes
Economical
production cost
Space saving
and usable
Performance
RSMP can be quickly moved up & down and well to well, resulting in fast delivery of diagnosis results within 15~50 minutes, whereas conventional magnetic particle systems require at least 3~4 hours. Therefore, the Up & down / well to well RSMP movement enables fast and effective reaction and washing.
* Patent registration :
10-2341666 (2021.12.16)
10-1997097 (2019.07.01)
US 11529628 (2022.12.20)
CN 110573884 (2023.04.28)
| VEUDx | Existing ELISA method | |
|---|---|---|
 |
 |
|
| Running time for diagnosis | 15~50 min. | 3~4 hours. |
| Single or multiplexed diagnostics | O | difficult |
| Reproducibility and accuracy of results | High accuracy | Normal accuracy |
| Amount of medical waste | Small | Large |
Overview
Ultra-sensitive Fluorescence Analysis System
The ultra-sensitive fluorescent imaging module has been manufactured and optimized for RSMP and the technology to image the whole well area at a time has been secured. Further, an remarkably improved signal to noise ratio and fluorescent sensitivity has been achieved.
Features
The entire well area can be imaged at a time with 100-times better fluorescent sensitivity and signal/noise ratio than those of conventional fluorescent microscopes and enable economical and efficient ultra-sensitive tests.
RSMP-specialized
1x lens
*NA → 0.3
Ultra-sensitive fluorescent
signal detection
Field of View
→ 50mm²
100-times better
fluorescent sensitivity
and signal/noise ratio
* NA : Numerical Aperture
Performance
Conventional fluorescence microscope
- signal
/noise ratio - 100-times better than conventional microscopes
- fluorescence
Sensitivity - 100-times better than conventional microscopes
The ultra-sensitive fluorescent imaging module, with RSMP-specialized 1x lens, enables entire well imaging in one action, effectively reducing imaging time. whereas the other conventional microscope could not detect any fluorescent signal even with a 4x lens.
* Patent application : 10-2022-0164462 (2022.11.30)
| Ultra-sensitive Fluorescence Analyzer |
|---|
 |
| N company’s fluorescence microscope |
|---|
 |
 |
- limit of detection: ultra-sensitive protein detection
- 0.625 pg/ml About 40-times higher sensitivity than that of conventional gamma interferon tests
- Dynamic range
-
3~5 logs
The immunoassays were performed using IFN-γ to measure the ultra-sensitivity and the dynamic range of VEUS.
As a result of ultra-sensitivity testing, the limit of detection was confirmed to be 0.625 pg/ml, which shows about 40-times higher sensitivity than that of the conventional gamma interferon test (~20 pg/ml).
As a result of dynamic range testing, the range of 0~1000 pg/ml (3 logs) was confirmed.
IFN-γ Test
Ultra-sensitive performance test Ex. Time : 300ms gain : 31
| pg/ml | Bright Field Image | Fluorescent Image |
|---|---|---|
| 0 |  |
 |
| 0.625 |  |
 |
| 1.25 |  |
 |
| 2.5 |  |
 |
Ultra-sensitive performance test result Target Conc.(pg/ml)
Dynamic range test Ex. Time : 200 ms gain : 25
| pg/ml | Bright Field Image | Fluorescent Image |
|---|---|---|
| 0 |  |
 |
| 0.625 |  |
 |
| 1.25 |  |
 |
| 2.5 |  |
 |
| 100 |  |
 |
| 500 |  |
 |
| 1000 |  |
 |
Dynamic range test result Target Conc.(pg/ml)
Overview
A.I Imaging Analysis Technology
NVIDIA GPU is used to improve the RSMP size detection and the multi-detection is conducted with the optimized AI model. More than 99% accuracy of multiplex detections has been secured and the results can be conveniently produced by calculating data.
Features
The result values with high accuracy can be obtained based on our patented AI-based multi-detection technology.
High accuracy
multi-detection
Convenient
data production
Patented AI-based
multi-detection technology
Performance
Before AI-based multi-detection technology, only 80% of multi-detection accuracy was obtained, but when RSMPs were demagnetized and the AI-based multi-detection technology was applied, more than 99% multi-detection accuracy has been achieved.
* Patent registration : 10-2217148 (2021.02.10)
| method | Accuracy of multi-detection (3 plexed assay) |
|---|---|
| Analysis utilizing AI-combined software → CV image processing technology | ~99% |
| Multi-detection through the AI technology |
|
|---|
| method | Accuracy of multi-detection (3 plexed assay) |
|---|---|
| Demagnetization of magnetic particles | ~80% |
| Multi-detection existing method |
|
|---|
“VEUDx” Vs “Next generation diagnostic technologies with conventional magnetic particle-based IVD products”
| EzDiatech VEUDx | A company product | B company product | C company product | D company product | |
|---|---|---|---|---|---|
| Work Scope | Prep./Assay/Analysis Process (All automated) |
Analysis Process (Needs prep./assay equipment) |
Analysis Process (Needs prep./assay equipment) |
Prep./Assay/Analysis Process (All automated) |
Prep./Assay/Analysis Process (All automated) |
| Analysis method | Bight Field image coding/ Fluorescence image analysis |
Bight Field image coding/ Fluorescence image analysis |
Bight Field image coding/ Fluorescence image analysis |
Chemiluminescence analysis | Bight Field image coding/ Fluorescence image analysis |
| Multiplexed assay | Possible | Possible | Possible | Impossible | Possible |
| Pre-treatment of the whole blood sample | Not required | Required | Required | Not required | Not required |
| Total test time | 15~50 min. | 3~4 hr. | 5~6 hr. | 20~30 min. | 3~4 hr. |
| Limit of Detection | 0.6 pg/ml | About 1 ~10 pg/ml | 0.1~1 pg/ml | Several | Dozens |