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www.sugentech.com QUANTITATIVE IMMUNOASSAY ANALYZER INTELLIGENT CLINICAL EXPERT SUGENTECH, INC. Room 214, 215, Miguntechnoworld II, 187, Techno 2-ro Yuseong-gu, Daejeon, 34025, Republic of Korea TEL: +82-31-701-5117 FAX: +82-42-367-3030 email: [email protected] www.sugentech.com MAKE IT BETTER TOMORROW

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Page 1: MAKE IT BETTER TOMORROW - 15.206.125.83

www.sugentech.com

QUANTITATIVE IMMUNOASSAY ANALYZER

INTELLIGENT CLINICAL EXPERT

SUGENTECH, INC.Room 214, 215, Miguntechnoworld II, 187, Techno 2-roYuseong-gu, Daejeon, 34025, Republic of KoreaTEL: +82-31-701-5117 FAX: +82-42-367-3030email: [email protected]

www.sugentech.com

MAKE IT BETTER TOMORROW

Page 2: MAKE IT BETTER TOMORROW - 15.206.125.83

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 instrument and its unique user friendly software provides an efficient data management system. Test results can be printed out using the built-in thermal printer or the connected local & network printer. Measurement data can be transferred to a remote computer or downloaded to USB Flash Memory.

Parameters Available: CRP, hs-CRP, Dual CRP(CRP+hs-CRP), PCT, Troponin I, HbA1c

* Other tests(β-hCG, Total-hCG, Influenza A&B, Zika IgM/IgG, Total IgE, PSA, TSH etc.) are coming soon.

Features• Both Qualitative and Quantitative Testing• Automatic Test• Dual Assay Modes - Standard Mode - Quick Mode (Read Now Mode) • Remote Access for Repair Service• Stores more than 10,000 test results • Instrument Check by Reference Kit • Internal Barcode Scanner to import Test Device, Lot

and Exp. Date • Data can be exported to PDF, Excel,

email, or LIS• Internal Thermal Printer• Language(UI) : English (Other

languages will be available soon)• Options - External keyboard - External network printer - External barcode scanner

Standard Mode

Quick Mode

1. Push to open the Cassette

Tray.

2. Insert the Cassette.

3. Load Specimen into the Cassette.

4. Close the Cassette Tray.

5. Wait for incubation.

6. Get results.

Reading only for quick analysis after operator’s manual incubation

Analysis including automatic incubation

5. Close the Cassette Tray.

3. Push to open the Cassette

Tray.

4. Insert the Cassette into the

Analyzer.

1. Load Specimen into the Cassette

(outside of the Analyzer).

2. Wait for incubation.

6. Get results.

SpecificationsOperating System Embedded Linux

Display 7” Color LCD (Resolution 800 x 480)

I/O Interface 4 x USB 2.0 / 1 x RJ-45 LAN Connector

Control Touch Screen

Supported Accessories Thermal printer (Built-in), Barcode scanner, Keyboard, and Mouse (Optional)

Patient Records 10,000 Patients

Rating 12 VDC, 5A

Power Consumption 30W

Dimensions (L x W x H) Approx. 230 x 250 x 250 mm (9.0 x 9.84 x 9.84 in.)

Weight Approx. 1.93 kg (68.1oz)

Operating Temperature Between 10°C(50°F) and 40°(104°F)

Storage Temperature Between -10°C(14°F) and 50°C(122°F)

Features -High sensitivity & repeatability -Management of Patient records

Environmental

-For indoor use only- Main supply voltage fluctuations should not exceed ±10%

- Transient over-voltages according to installation category II

-Pollution degree 2

Page 3: MAKE IT BETTER TOMORROW - 15.206.125.83

SpecificationsSample Type Whole blood, serum, or plasma

Sample Volume 5 μL

Measuring Range

CRP 2.5 - 300 mg/L (Cutoff 10 mg/L)

hsCRP 0.1 – 10 mg/L (Cutoff 1 mg/L)

dual CRP 0.5 – 200 mg/L (Inflammation cutoff 10mg/L, cardiovascular disease cutoff 1 mg/L)

Reference Value CRP<10 mg/L, hsCRP<1.0 mg/L

Precision <10% CV in working range

Measuring time 5 minutes

Package 25 tests/box

Diluent in the kit YES

Storage Temp. 2-30°C (36-86°F)

Shelf Life 24 months

Intended UseINCLIX™ CRP / hsCRP / dualCRP Test quantitatively measures C-reactive protein (CRP) concentration in whole blood, serum or plasma using the INCLIX™ analyzer. For in vitro diagnostic use only.

Summary and Explanation of the TestC-reactive protein (CRP) is synthesized by the liver and is one of the acute phase proteins. In the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.

Low level of CRP can be the indicator of cardiovascular disease in apparently healthy people. However, increases in CRP are nonspecific, and should be interpreted in the context of a complete clinical evaluation. Apparently healthy individuals with an elevated hsCRP value should have the test repeatedly to rule out a recent response to undetected infection or tissue injury.

PrincipleINCLIX™ CRP / hsCRP / dualCRP Test is a rapid test based on immunochromatography technique “lateral flow” using highly specific monoclonal antibodies. The detection antibody-gold conjugate and CRP leads to the generation of a reddish colored band on the strip. The intensity of the band depends on quantity of CRP molecules and is analyzed by INCLIX™ analyzer for quantitative readout.

250

200

150

100

50

INCL

IXTM

CRP

(mg/

L)

ADVIA 1800 CRP (mg/L)

Y=0.903X+1.216R=0.991

50 100 150 200 2500

0

CRP / hsCRP / dualCRP

SpecificationsSample Type Serum or Plasma

Sample Volume 100uL

Measuring Range 0.25- 40 ng/mL (Cutoff 0.5 ng/mL)

Reference Value PCT < 0.5 ng/mL

Precision <15% CV in working range

Measuring time 15 minutes

Package 25 tests/box

Diluent in the kit NO

Storage Temp. 2-30°C (36-86°F)

Shelf Life 24 months

Intended UseINCLIX™ PCT Test quantitatively measures Procalcitonin (PCT) concentration in serum and plasma using the INCLIX™ analyzer. For in vitro diagnose use only.

Summary and Explanation of the TestProcalcitonin (PCT) is reliable and specific biomarker to diagnose bacterial infection and sepsis. Because bacterial infection progresses rapidly to severe systemic infection, early diagnosis is important for appropriate clinical treatment. It has been shown that PCT can contribute to optimization of antibiotic therapy and monitor treatment duration.

PrincipleINCLIX™ PCT Test is a rapid test based on immunochromatography technique “lateral flow” using highly specific monoclonal antibodies. The detection antibody-gold conjugate and PCT leads to the generation of a reddish colored band on the strip. The intensity of the band depends on quantity of PCT molecules and is analyzed by INCLIX™ analyzer for quantitative readout.

PCT

10

20

30

40

INCL

IXTM

PC

T (n

g/m

L)

ADVIA Centaur XP PCT (ng/mL)

Y=1.074X+0.080R=0.979

10 20 30 400

0

Page 4: MAKE IT BETTER TOMORROW - 15.206.125.83

Clinical SignificanceAcute Mycocardial Infarction (AMI)

<0.1 ng/mL Normal

0.1-0.5 ng/mL Borderline

>0.5 ng/mL Abnormal

Clinical SignificanceHbA1C-NGSP(%)

3 – 6.5% Reference range

>7% Target to treatment

>8% Change of therapy in diabetes

SpecificationsSample Type Whole blood, serum, or plasma

Measuring range 0.1 - 50 ng/mL

Precision <10% CV in working range

Measuring time 10 minutes

Shelf Life 24 months

Intended UseINCLIX™ Troponin I quantitatively measures troponin I concentration in whole blood, serum or plasmausing the INCLIX™ analyzer. For in vitro diagnostic use only.

Summary and Explanation of the TestCardiac troponin I (Tn I) is a protein found in myocardial muscle and the most sensitive biomarker for detection of acute myocardial infarction (AMI).The concentration of Tn I in the healthy human is below about 0.5 ng/ml and the level of Tn I is increased within 4-6 hours after the onset of chest pain. After cardiac injury occurs, peak in approximately 8 to 28 hours, and remain elevated for 3 to 10 days following AMI. The Tn I test is well known to be an important prognostic indicator of heart disease.

PrincipleThe Tn I Test is based on immunochromatography technology. When the sample is loaded to the device, the detection antibody which is conjugated with the colloidal gold in the dried pad binds to Tn I and flows through the membrane. The detection antibody-gold conjugate and Tn I move to the test line area and are accumulated by the capture antibody immobilized on the membrane. This leads to the generation of a reddish colored band. The intensity of the band depends on quantity of Tn I molecules and is analyzed by INCLIX™ analyzer for quantitative readout.

Troponin I

SpecificationsSample Type Whole blood

Sample Volume Whole blood 5μL

Measuring range 4-14%

Precision <10% CV in working range.

Measuring time 3 minutes

Shelf Life 24 months

Intended UseINCLIX™ HbA1c quantitatively measures HemoglobinA1c(HbA1c) concentration in whole blood using the INCLIX™ analyzer. For in vitro diagnostic use only.

Summary and Explanation of the TestHemoglobin A1c (glycated hemoglobin; HbA1c; A1c) test is the immunochromatography assay and intend for the quantitative determination of stable HbA1c in human blood. In this test system, HbA1c level is expressed in a percent as a good indicator to manage long-term glucose control in diabetes.

PrincipleThe HbA1c Test is the immunochromatography method to determine the percentage of glycated HbA1c in human blood. The detector antibody conjugated with colloidal gold can bind to HbA1c in human blood at conjugate pad where it dried. The detector antibody and HbA1c complex flows through membrane to where capture antibody for total hemoglobin immobilized at membrane of strip. The signal intensity is measured with the INCLIX™ analyzer and the signal reflectance is calculated and shown as a percentage of concentration with established standard with known the percentage of HbA1c in blood samples.

HbA1c