Medical Products Supplies Companies

721-26 Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, 28161 Cheongju-si, Chungcheongbuk-do
Korea, Republic
Telephone +82 2 22265282
Fax +82 42 3673030
jyoung@sugentech.com
http://www.sugentech.com

Product Categories

Product categories

02 Laboratory Technology
02.01 Analyser systems / equipment

Analyser systems / equipment

Immunoblot System
[professional POCT] TRF system and the tests
[Professional POCT] INCLIX, Quantitative Immunoassay Analyzer

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.01 Immuno assay testing

Immuno assay testing

[Immunoblot] Allergy Screen Test (human & animal)
[Professional POCT] INCLIX HbA1c Test
[Professional POCT] INCLIX Troponin I Test
[Professional POCT] INCLIX PCT Test
[Professional POCT] INCLIX CRP / hsCRP / dual CRP Test
[Professional POCT] INCLIX Total IgE Test

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.02 Diagnostic rapid tests

Diagnostic rapid tests

[Professional POCT] SGTi-flex Influenza A&B Test

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.04 Other equipment for immunochemistry and immunology

Other equipment for immunochemistry and immunology

[Home-use POCT ] Surearly SMART(bluetooth connection)
[self-testing POCT] Surearly Digital Pregnancy Test
[self-testing POCT] Surearly Digital Ovulation Test

03 Diagnostic Tests
03.05 Infectious immunology testing
03.05.03 Other infectious immunology testing

Other infectious immunology testing

[Professional POCT] INCLIX Blood TB(tuberculosis) Test, Ag detection kit, CE marked
[Professional POCT] SGTi-flex Influenza A&B Test
Our products

Product category: Analyser systems / equipment
Immunoblot System

Sugentech’s Automatic systems of immunoblot and western blot guarantee much faster and more accurate result of measurement, it is designed to be more convenient, stable and user friendly with over 10 years experience.

This automatic system makes all the diagnosis process like Western Blot and Hybridization Strips automatically and it can be customized on your various applications and requirements.

User-friendly customizing software and rapid customer service of device and the one for the most outstanding advantages only provided by Sugentech

S-Blot 3 (Full automation system)
• Sample Identification – Sample – Incubation- Drying – Analysis – Auto Cleaning
• Up to 40 samples analysis per run
• hLLD (pressure & capacitive liquid level detection)
• Real Time Pump Calibration → Reliable Dispensing accuracy
• Smart moving camera

S-Blot 2 (Semi automation system)
• Sample(Manual) – Incubation – Drying – Analysis- Auto Cleaning
• Up to 48 samples analysis per run
• Detect concentration of specific antibody by membrane
• High accurate dispensing module
• Sensitive and stable result by high resolution detector

S-Blot 1 (Liquid handler)
• Incubation – Dry – Auto Cleaning
• Up to 20 samples per run
• Efficient Drying Module → Rapidly obtain result
• High dispensing Accuracy
• Compact Design

S-Blot Screen (Strip Reader)
• Rapid quantities immunoassay analyzer, Color & Fluorescence & TRF
• Multiple test
• Sensitive and stable results by high resolution detector
• 7 inch Touch Screen
• Useful data treatment

Product category: Immuno assay testing
[Immunoblot] Allergy Screen Test (human & animal)
Sugentech Allergy Screen test (human & animal)

Easy and Fast
• Using automated device
• 3hr 30min for 48 tests

Small sample, More allergens
• Test with 50ul samples per one panel.

Convenient and useful system
• From manual system to full auto system
• Customized panel

High sensitivity & reproducibility
• Highly reactive allergen & Good quality strip
• Unique and accurate analysis algorithm

Product category: Analyser systems / equipment
[professional POCT] TRF system and the tests
What is Time-Resolved Fluorescence?
TRF is a fluorescence measurement method using very specific fluorescent molecules called lanthanum chelate labels. The main difference from standard fluorescence measurements is the timing of the excitation/emission process.

TRF system
• Unique optical system and analysis method (patented)
• High sensitivity & repeatability
• Easy to use and convenient interface
• Qualitative and quantitative analysis of various applications for POCT
• Support LIS, Bar code & QR code recognition

Test items (under development, available in 2020)
Vitamin D, Adeno&Influenza, Periodontitis tests, etc.

Product category: Analyser systems / equipment
[Professional POCT] INCLIX, Quantitative Immunoassay Analyzer
INCLIX™ is an immunochromatographic analyzer providing immediate point-of-care testing (POCT) at patient care settings or clinical laboratories. It facilitates automatic detection of various biomarkers for cardiovascular disease, infectious disease, cancer, diabetes, allergy, and etc. with high accuracy and sensitivity.

INCLIX™ analyzer is a compact, easy-to-use and cost-effective multi-parameter POCT instrument and its unique user friendly software provides an efficient data management system.

* Parameters Available with CE mark: HbA1c, PCT, Troponin I, CRP, hsCRP, Dual CRP, Influenza A&B, β-hCG, Total IgE, Zika Ag
* Other tests (TSH, D-dimer) are also coming soon in 2019.

• Good accuracy owning to superior CMOS sensor & our own Algorism
• 10,000 test results data storage
• Instrument Check by Reference Kit
• Remote Support available (when connected via Internet)
• Built-in Thermal Printer and Barcode Scanner
• Data export to USB(PDF, Excel), Email and LIS
• Storage Temperature of Test Cassette & Buffer : Room temperature, 2 ~ 30 ℃
• Shelf Life of Test Cassette & Buffer : 24 months

Product category: Other infectious immunology testing
[Professional POCT] INCLIX Blood TB(tuberculosis) Test, Ag detection kit, CE marked

New Biomarker based Diagnostics
New Biomarker based Diagnostics for “active” TB infection diagnosis (c.f. IGRA is only for LTBI)
• Specificity : About 95% over cultivation result
• Sensitivity :
– Over 85% on the culture result of Pulmonary TB patients
– Over 60% on the extra-pulmonary TB patients

Simple steps and Quick test results (40 minutes only!)
• Operator Safety &Test Productivity
• Patient Safety with lower exposure of irrelevant antibiotics prescription

No pain on the Sputum!
It is very difficult to get a sputum (especailly from children and elderly) and even with good quality.
It is reported that only less than 30% of them has a good quality.
We can diagnose active TB infection with small volume(10ul) of blood(serum or plasma).

Lower test cost than Molecular Diagnosis
• Lower Operational cost with simple steps
• Lower price than the PCR diagnostics

Precision of measurement (Repeatability/Reproducibility)
100%, The results were compared within the test, between the tests, between the test days, within the test room, between the test sites, and between lots.

Product category: Immuno assay testing
[Professional POCT] INCLIX HbA1c Test
INCLIX HbA1c Test (CE marked, NGSP certified)

INTENDED USE
INCLIX™ HbA1c along with INCLIX™ Analyzer is an immunochromatographic in-vitro diagnostic device for quantitative determination of Glycated Hemoglobin (HbA1c) in human blood. The test is used as an aid to diagnose diabetes and for monitoring long-term glycemic control in patients with diabetes.

PRINCIPLE
This test uses a sandwich immunoassay using gold nanoparticle-based immunochromatographic method. When dropping the specimen diluted in diluent buffer to the sample well of the cassette, it moves through the nitrocellulose membrane on the strip.
The antigen-antibody complex is combined with the capture antibody and it is colored as purple red by gold particle.
The intensity of the band depends on quantity of glycated hemoglobin molecules.
Results are automatically calculated by INCLIX™ Analyzer and the HbA1c concentration can be verified immediately.

Specifications
• Sample Type : Whole blood
• Sample Volume : Whole blood 5μL
• Measuring range : 4-14%
• Precision : <10% CV in working range.
• Measuring time : 3 minutes
• Storage temperature: 2-30°C (36-86°F)
• Shelf Life : 24 months

Method comparison
Comparison studies between the candidate device (INCLIX™ HbA1c) and the predicate device (Tosoh, HLC-723 G11) were conducted by lab professionals, using 100 specimens. The linear regression line and correlation coefficient were found to be : y = 1.002x + 0.0135; R = 0.9875.

Product category: Immuno assay testing
[Professional POCT] INCLIX Troponin I Test
INCLIX Troponin I (CE marked)

INTENDED USE
diagnostic device for quantitative determination of cardiac Troponin I (TnI) in serum, plasma and whole blood. The test is used as an aid to diagnose Acute Myocardial Infarction
(AMI).

PRINCIPLE
This test uses a sandwich immunoassay using gold nanoparticle-based immunochromatographic method. When dropping the specimen diluted in diluent buffer to the sample well of the cassette, it moves through the nitrocellulose membrane on the strip.
The antigen-antibody complex is combined with the capture antibody and it is colored as purple red by gold particle.
The intensity of the band depends on quantity of Troponin I molecules. Results are automatically calculated by INCLIX™ Analyzer and the Troponin I concentration can be verified immediately. Troponin I concentrations are expressed as ng/mL.

Specifications
• Sample Type : Whole blood, serum, or plasma
• Sample Volume : 100uL
• Measuring range : 0.1 – 50 ng/mL
• Precision : <10% CV in working range
• Measuring time : 10 minutes
• Storage temperature: 2-30°C (36-86°F)
• Shelf Life : 24 months

Method comparison
Comparison studies between the candidate device (INCLIX™ Troponin I) and the predicate device (i-CHROMA™ Tn-I) were conducted by lab professionals, using 105 specimens. The linear regression line and correlation coefficient were found to be : y =
Product category: Immuno assay testing
[Professional POCT] INCLIX PCT Test
INCLIX PCT Test (CE marked)

INTENDED USE
INCLIX™ PCT along with INCLIX™ Analyzer is an immunoassay for quantitative determination of Procalcitonin (PCT) in human serum/plasma. The test is useful in the diagnosis of bacterial infection and sepsis.

PRINCIPLE
This test uses a sandwich immunoassay using gold nanoparticle-based immunochromatographic method. When dropping the specimen diluted in diluent buffer to the sample well of the cassette, it moves through the nitrocellulose membrane on the strip.
The antigen-antibody complex is combined with the capture antibody and it is colored as purple red by gold particle.
The intensity of the band depends on quantity of PCT molecules. Results are automatically calculated by INCLIX™ analyzer and the PCT concentration can be verified immediately.

Specifications
• Sample Type : Serum or Plasma
• Sample Volume : 100uL
• Measuring range : 0.25- 40 ng/mL (Cutoff 0.5 ng/mL)
• Precision : <15% CV in working range
• Measuring time : 15 minutes
• Storage temperature: 2-30°C (36-86°F)
• Shelf Life : 24 months

Method comparison
Comparison studies between the candidate device (INCLIX™ PCT) and the predicate device (ADVIA Centaur™ XP PCT) were conducted by lab professionals, using 123 specimens. The linear regression line and correlation coefficient were found to be : y=1.074x + 0.080; R =0.979
Product category: Immuno assay testing
[Professional POCT] INCLIX CRP / hsCRP / dual CRP Test
INCLIX CRP / hsCRP / dual CRP Test (CE marked)

PRINCIPLE
This test uses a sandwich immunoassay using gold nanoparticle-based immunochromatographic method. When dropping the specimen diluted in diluent buffer to the sample well of the cassette, it moves through the nitrocellulose membrane on the strip.
The antigen-antibody complex is combined with the capture antibody and it is colored as purple red by gold particle.
The intensity of the band depends on quantity of CRP molecules. Results are automatically calculated by INCLIX™
analyzer and the CRP concentration can be verified immediately.

Specifications
• Sample Type : Whole blood, serum, or plasma
• Sample Volume : 5uL
• Measuring range (CRP) : 2.5 – 300 mg/L (Cutoff 10 mg/L)
• Measuring range (hsCRP) : 0.1 – 10 mg/L (Cutoff 1 mg/L)
• Measuring range (dual CRP) : 0.5 – 200 mg/L (Inflammation cutoff 10mg/L, cardiovascular disease cutoff 1 mg/L)
• Precision : <10% CV in working range
• Measuring time : 5 minutes
• Storage Temperature : 2-30°C (36-86°F)
• Shelf Life : 24 months

Method comparison (CRP)
Comparison studies between the candidate device (INCLIX™ CRP) and the predicate device (ADVIA 1800 CRP) were conducted by lab professionals, using 200 specimens. The linear regression line and correlation coefficient were found to be : y = 0.903x + 1.216; R = 0.991

Method comparison (hsCRP)
Comparison studies between the candidate device (INCLIX™ hsCRP) and the predicate device (ADVIA 1800 CRP, Wide range) were conducted by lab professionals, using 200 specimens. The linear regression line and correlation coefficient were found to be : y =
1.080x – 0.219; R = 0.981.

Method comparison (dual CRP)
Comparison studies between the candidate device (INCLIX™ dual CRP) and the predicate device (ADVIA 1800 CRP, Wide range) were conducted by lab professionals, using 200 specimens. The linear regression line and correlation coefficient were found
to be : y = 1.118x – 0.728; R = 0.994.

Product category: Immuno assay testing
[Professional POCT] INCLIX Total IgE Test
IINCLIX Total IgE (CE marked)

INTENDED USE
INCLIX™ Total IgE along with INCLIX™ Analyzer is an immunoassay for quantitative determination of total immunoglobulin E (IgE) in serum or plasma. The test is used as an aid in the diagnosis of IgE mediated allergic disorders.

PRINCIPLE
This test uses a sandwich immunoassay using immunochromatographic method. When dropping the specimen diluted in diluent buffer to the sample inlet of cassette, it is absorbed into the sample pad and it soaks a conjugate pad. Total IgE in the sample is combined with the detection antibody gold conjugate in the conjugate pad and it forms antigen-antibody complex. It moves through the nitrocellulose membrane on the strip. The antigen-antibody complex is combined with the capture antibody which is fixed to the membrane and it is colored as purple red by gold particle. The intensity of the band depends on quantity of IgE molecules. Results are automatically calculated by INCLIX™ analyzer and the IgE concentration can be verified immediately.

Specifications
• Sample Type : serum or plasma
• Sample Volume : 10uL
• Measuring range : 10-2000 IU/mL
• Precision : <10% CV in working range
• Measuring time : 10 minutes
• Storage temperature: 2-30°C (36-86°F)
• Shelf Life : 24 months

Method comparison
Comparison studies between the candidate devices (INCLIX™ Total IgE) and the predicate device (ADVIA Centaur Total IgE) were conducted by lab professionals, using 192 specimens. The linear regression line and correlation coefficient were found be: y = 0.918x + 10.35; R = 0.997

Product category: Diagnostic rapid tests, Other infectious immunology testing
[Professional POCT] SGTi-flex Influenza A&B Test
SGTi-flex Influenza A&B Test (CE marked, qualitative assay)

INTENDED USE
SGT i-flex Influenza A&B is an immunoassay for qualitative detection of Influenza virus type A or type B antigens directly from nasopharyngeal swab specimens. The test is used as an aid to detect the influenza viruses by simultaneously distinguishing between A and B, which are human-infected subtypes. The test is not intended to detect influenza C antigens.

PRINCIPLE
The principle of SGT Influenza A & B is the qualitative assay to detect influenza virus in the nasopharynx. Influenza virus swabs from nasopharynx are suspended in sample extracts and the suspension is dispensed into the kit. Influenza virus nucleoprotein allows the diagnosis of influenza viruses through visual inspection and analytical device by antigen-antibody immunochromatography combined with nucleoprotein specific antibody and gold in the kit. It is also possible to diagnose influenza A and B simultaneously and separately.

Specifications
• Sample Type : nasopharyngeal swab
• Extracted sample loading volume: 4 drops
• Reaction time: 3~10 minutes after loading the sample
• Storage temperature: 2-30°C (36-86°F)
• Shelf Life : 24 months

Product category: Other equipment for immunochemistry and immunology
[Home-use POCT ] Surearly SMART(bluetooth connection)

Smart personal healthcare Device
Interlocking between sensor and smartphone app.
Implementation of smart diagnosis function through pattern analysis of test result.
Test sticks are sold separately for a refill. (more cost-effective)
Replaceable lithium battery

Female Hormone Optimal Urine Test (for self-testing)
Management of women’s diseases across the life cycle through the 5 female hormones analysis.
Three types of Test Sticks are selling separately.
– Pregnancy test (including week estimation(semi-quantiative)
– Ovulation test(including dual hormones(LH, estrogen) detection)
– Menopause test.

Microalbumin Optimal Urine Test (for ETC-home use )
A urine microalbumin test is a test to detect very small levels of a blood protein (albumin) in your urine.
A microalbumin test is used to detect early signs of kidney damage in people who are at risk of developing kidney disease.
24-hour urine is the best or alternatively the first urine in the early morning could be possible, both of which are hard(inconvenient) to pick up as a sample. The innovative technology of Surearly SMART enables patients to test conveniently at home.

Product category: Other equipment for immunochemistry and immunology
[self-testing POCT] Surearly Digital Pregnancy Test
Korea’s First & No.1 Digital Test
ACCURATE and SIMPLE!
Test result is displayed on LCD with digital word (YES or NO) and symbol.

• Single-use or multiple-use type
• Rapid, Easy-to -Read DIGITAL results in about 3 minutes
• Over 99% accurate
• User’s procedural error detection
• hCG hormone detection in urine
• Sensitivity level of 25mIU/mL
• US FDA( 510(k) cleared) & CE certified

Product category: Other equipment for immunochemistry and immunology
[self-testing POCT] Surearly Digital Ovulation Test
Korea’s First & No.1 Digital Ovulation Test
EASY-TO-READ and ACCURATE!
Test result is displayed on LCD with digital word and symbol.
[YES means ovulation will soon occur within the next 24~36 hours.]

• Rapid, Easy-to -Read DIGITAL results in 3 minutes
• Over 99% accurate
• User’s procedural error detection
• LH hormone detection in urine
• Sensitivity level of 25mIU/mL
• US FDA registered, CE marked

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About Us

Company details
Sugentech is the 28th INNOPOLIS Research Institute Spin-off Company of Ministry of Science, ICT and Future Planning, Korea, which was established in 2011 by experienced executives and technical experts in the field of in-vitro diagnostics.

Sugentech is a FDA registered, ISO13485 certified In-Vitro Diagnostic (IVD) company with robust and exhaustive Bio-IT convergence technologies. Sugentech covers from R&D to manufacture of its IVD products, based on its own platforms such as Self-Testing, professional Point-of-Care Testing, and Fully Automated immunoblot Lab System.

As an innovative diagnostics company, Sugentech provides reliable and excellent information through rapid diagnostic tests with the leading-edge technology you need.

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