STANDARD F Fluorescent Immunoassay System

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STANDARD F STANDARD F100 STANDARD F200 STANDARD F400 STANDARD F2400 Fluorescent Immunoassay System Qualitative Quantitative

Transcript of STANDARD F Fluorescent Immunoassay System

Page 1: STANDARD F Fluorescent Immunoassay System

STANDARD F

STANDARD F100

STANDARD F200

STANDARD F400

STANDARD F2400

FluorescentImmunoassaySystem

Qualitative Quantitative

Page 2: STANDARD F Fluorescent Immunoassay System

CAL-1 CAL-2 CAL-3

Advantages of STANDARD F

STANDARD F Analyzers are qualitative and quantitative fluorescent immunoassay systems and have been designed for easy and reliable measuring of diverse parameters. STANDARD F series offers 4 different models that can be used depending on your workflow requirements. Rapid, highly accurate and reliable results help you to reduce uncertainty of treatment and make better the quality of patients care.

ConnectivityㆍDirect LIS/HIS ㆍHL7 v2.6(PCD-01)ㆍPOCT1-A

User friendly interface7” Color Touch Screen

Minimized riskof contamination

Keep the entrance shut unless the testing is in progress.

The dust cover protects against contamination.

Convenient reportBuilt-in Printer

Compact desktop200 x 240 x 205

2.5 kg

Portable systemBattery(AA x 4)or AC/DC adapter

Graphic LCDResult is presenstedclearly and concisely

Hand held size105 x 135 x 100

700 gConvenient processAuto coding procedure

by recognizing 2D barcode

Variable test parameters9 test parameters are

available now

STANDARD F200

STANDARD F100

RSV Ag

Leg. Ag

Flu. A/B

Accurate resultTake an accurate collection with Fixed volume dropper.

Reliable resultProvide Calibration Set and Control reagent having more confidence in the result.

Calibration Set Control Bead Coltrol Swab

Exactvolume

Page 3: STANDARD F Fluorescent Immunoassay System

UV lightsource

detector

antibody

UV LightVisi

ble Light

sample flow

absorbentpad

antibody

test line

europium pad

antigen

12

3

4

6

Flu A/B

NAME patient ID

Simple Test Procedure

1. Simple and easy to use Familiar lateral flow test platform

2. Europium-based fluorescent chemistryLarge Stoke’s shift permits sensitive fluorescence detection and narrow emission peak permits mutiplex detection.

3. Random access and No-coding via 2D barcode system Automatic strip recogrecognition (item, Lot No., serial No., coding information, expiry date)

4. Internal quality controlThe control line checks that the test has progressed completely and correctly.

5. Time saving by early detectionIn case of high titer samples, the analyzer automatically shows the test results in 1.5 minutes. (Influenza A/B)

Few mins

Insert the strip to initiate test processing.

Apply the specimen into a strip. Read the result when completed.

READ ONLY modeHigh-throughput procedure for multiple tests

Apply the specimen into a strip. Leave the strip outside of the analyzer. Wait for the required time.

Insert the strip into the analyzer. It will take less than 1 minute for the result.

Technical Advantages

6. Name awarenessDouble check barcode ID read by STANDARD F Analyzer and patient ID with naked eye to avoid confusion.

STANDARD TEST modeAutomated procedure for single test

Leg. Ag

Page 4: STANDARD F Fluorescent Immunoassay System

STANDARD F Enables Accurate Detection of Diseases

STANDARD F Covers a Wide Scope of Medical Diagnostic Test

Slope

0.9957

Correlation

0.9987

CV

10%

Influenza A/B ● ● ● ● ● ●

RSV Ag ● ● ● ●

Strep A Ag ● ● ● ● ●

S.pneumoniae Ag ● ● ● ● ●

Legionella Ag ● ●

CRP ● ●

● ●

● ● ●

●PCT ● ●

HbA1c ● ● ● ●

U-Albumin ● ●

Clinical chemistry analyzer

Clinical chemistry analyzer

Outstanding Sensitivity of Qualitative FIAs - STANDARD F Influenza A/B FIA

++------

++++++

+/--

STANDARD F Influenza A/B FIA isat least 4 times more sensitivethan commercialized ICT

Highly Accurate Result of Quantitative FIAs - STANDARD F PCT FIA

Pediatrics Obstetrics & Gynecology ENT Respiratory EndocrinologyLaboratory

There is a high correlation between STANDARD Fand clinical chemistry analyzer

Influenza ANo. PFU/ml

12345678

310,00031,0003,100310155783919

ICT STANDARD F

++----

++++

+/--

Influenza BNo. PFU/ml

123456

22,0002,20022022116

ICT STANDARD F

Page 5: STANDARD F Fluorescent Immunoassay System

STANDARD F Specification

Series

Image

Test method

Analysis

Test capacity

Quick test mode

Power

Display

Printer

LIS /HIS

connectivity

Auto-ID

Dimension (mm)

Accessories

Weight

F 100

1 test each

Available

AC/DC adapter

or Battery(AA x 4)

Graphic LCD

External

Bluetooth classic

2D barcode

105 x 135 x 100

Thermal printer

0.7 kg

F 200

1 test each

Available

AC/DC adapter

7” Color Touch Screen

Built-in

• HL7 v2.6(PCD-01)

• POCT1-A

2D barcode

200 x 240 x 205

Mouse/keyboard

Barcode scanner

2.5 kg

F 400

4 tests simultaneously

Not Available

AC/DC adapter

7” Color Touch Screen

Built-in

• HL7 v2.6(PCD-01)

• POCT1-A

2D barcode

320 x 280 x 238

Mouse/keyboard

Barcode scanner

3.8 kg

Fluorescent immunoassay

Quantitative & Qualitative test

F 2400

70 Tests per hour

Random access

Not Available

Power Cable

(SMPS adapted)

7” Color Touch Screen

Built-in

• HL7 v2.6(PCD-01)

• POCT1-A

2D barcode

410 x 555 x 282

Mouse/keyboard

Barcode scanner

14.3 kg

Available Soon

HIV, HCV, HBsAg, Malaria Ag, C.difficile A/B GDH, Vitamin D, Cystatin C, TnI, CK-MB, hs-CRP, TSH, AFP, CEA,

PSA, FOB

STANDARD F Available Tests

Respiratory

disease

Chronic

disease

Infection

Test item Sample type Time to result Measurementranges

Storagetemperature

Influenza A/B FIA

RSV Ag FIA

Strep A Ag FIA

Legionella Ag FIA

S.Pneumoniae Ag FIA

HbA1c FIA

U-Albumin FIA

CRP

PCT FIA

Nasal swab

Nasal swab

Throat swab

Urine

Urine

Whole blood

Urine

Whole blood/

Serum/Plasma

Serum

1.5~10 minutes

5~15 minutes

5 minutes

5~15minutes

5~15minutes

5 minutes

5 minutes

WB : 5 minutes

S/P : 3 minutes

15 minutes

-

-

-

-

-

4-15%

(20-140 mmol/mol)

5-250 mg/L

WB : 8 – 150 mg/L

S/P : 5 – 130 mg/L

0.1 – 50 ng/mL

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

2-30°C / 36-86°F

Page 6: STANDARD F Fluorescent Immunoassay System

STANDARD F Analyzers

Connectivity with Mobile, Cloud and LIS/HIS

Ordering Information

Personal computer

Data Share

Cloud server

LIS/HIS

Cat No. Description Unit Printer Weight W(mm)/L(mm)/H(mm)

F100

F200

F400

F2400

10FA10

10FA20

10FA40

10FA24

1

1

1

1

External

Built-in

Built-in

Built-in

0.7 kg

2.5 kg

3.8 kg

14.3 kg

105 x 135 x 100

200 x 240 x 205

320 x 280 x 238

410 x 555 x 282

STANDARD F Tests

Cat No. Description Test/kitQuantity /carton box W(mm)/L(mm)/H(mm)

Influenza A/B FIA

RSV Ag FIA

Strep A Ag FIA

Legionella Ag FIA

S.Pneumoniae Ag FIA

HbA1c FIA

U-Albumin FIA

CRP

PCT FIA

10INF10D

10RSV10D

10STR10D

10LEG10D

10SPN10D

10A1C10D

10UAL10D

10CRP10D

10PCT10D

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

25 Tests/kit

40 kits/box

40 kits/box

40 kits/box

40 kits/box

40 kits/box

40 kits/box

40 kits/box

40 kits/box

40 kits/box

823 x 525 x 420

823 x 525 x 420

707 x 440 x 420

595 x 310 x 420

595 x 310 x 420

635 x 461 x 420

635 x 461 x 420

635 x 461 x 420

635 x 461 x 420

Head Office C-4&5Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREAFactory 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbukdo, 28161, REPUBLIC OF KOREA

Tel +82-31-300-0400 Fax +82-31-300-0499 E-mail [email protected] Website www.sdbiosensor.comLEF900EN / SDC.1611 © 2016 SD BIOSENSOR. All rights reserved.

Mobile STANDARD F Fluorescent Imm

unoassay System