STANDARD F

STANDARD F100

STANDARD F200

STANDARD F2400

FluorescentImmunoassaySystem

Qualitative QuantitativeFlu A/B HbA1c

STANDARD F Specification

Connectivity with Mobile, Cloud and LIS/HIS

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 2400

70 Tests per hour

Random access

Not Available

Power Cable

(SMPS adapted)

10” Color Touch Screen

Built-in

• HL7 v2.6(PCD-01)

• POCT1-A

2D barcode

510 x 566 x 297

Mouse/keyboard

Barcode scanner

20.0 kg

Personal computer

Data Share

Cloud server

LIS/HIS

Mobile

Fluorescent immunoassay

Quantitative & Qualitative test

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 3 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 parameters23 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 Control Swab

Exactvolume

CAL-3CAL-1 CAL-2

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 recognition (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 mode (only for the qualitative test items)High-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 awarenessSTANDARD F Analyzer scans and prints a handwritten patient ID on the device, which allows of double checking the patient ID labeled on the sample.

STANDARD TEST modeAutomated procedure for single test

Leg. Ag

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%Clinical chemistry analyzer

Clinical chemistry analyzerComparison of STNANDARD F PCT FIA and 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

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

Pediatrics

Wards

E

mergency Room

M

edical Laborato

ry

Q

uaratine agency

Health center

Armed forces

Airport

STANDARD F Analyzers

Ordering Information

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

F100

F200

F2400

10FA1010FA2010FA24

1

1

1

External

Built-in

Built-in

0.7 kg

2.5 kg

20.0 kg

105 x 135 x 100

200 x 240 x 205

510 x 566 x 297

STANDARD F Tests

Category Cat. No. Test item

10INF10D

10RSV10D

10STR10D

10LEG10D

10SPN10D

Influenza A/B FIA

RSV Ag FIA

Strep A Ag FIA

Legionella Ag FIA

S. pneumoniae Ag FIA

10ZK10D

10ZK20D

10DEN10D

10DEN20D

10CHI10D

Zika Ag FIA

Zika IgM/IgG FIA

Dengue NS1 Ag FIA

Dengue IgM/IgG FIA

Chikungunya IgM/IgG FIA

10CKM10B

10TNI10B

10HSC10B

10DDI10B

CK-MB FIA

TnI FIA

hs-CRP

D-dimer FIA

10CRP10B

10PCT10B

10PCT20B

CRP

PCT FIA (Serum)

PCT FIA

10A1C10B

10UAL10B

HbA1c

U-Albumin FIA

10BHC10B β-hCG FIA

10PSA10B PSA FIA

10HCV10D HCV FIA

Nasal swab

Nasopharyngeal swab

Throat swab

Urine

Urine

WB/S/P

WB/S/P

WB/S/P

WB/S/P

WB/S/P

WB/P

WB/P

WB/S/P

WB/P

WB/S/P

S

WB/S/P

WB

Urine

WB/S

WB/S/P

- Storage Temperature: 2-30℃/36-86℉

- Storage Temperature: 2-30℃/36-86℉ - WB: Whole blood, S: Serum, P: Plasma, QL: Qualitative, QN: Quantitative

WB/S/P

-

-

-

100㎕

100㎕

100㎕

10㎕

100㎕

10㎕

10㎕

100㎕

100㎕

5㎕

10㎕

5㎕

50㎕

100㎕

5㎕

3㎕

100㎕

WB: 10㎕S/P: 100㎕

100㎕

10㎕

QL

QL

QL

QL

QL

QL

QL

QL

QL

QL

QN

QN

QN

QN

QN

QN

QN

QN

QN

QN

QN

QN

QL

25

25

25

25

25

25

25

25

25

25

20

20

20

20

20

20

20

20

20

20

20

20

25

1.5~10 mins

5~15 mins

5 mins

5~15 mins

5~10 mins

15 mins

15 mins

15 mins

15 mins

15 mins

15 mins

15 mins

3 mins

3 mins

3 mins

15 mins

15 mins

3 mins

5 mins

WB: 10 minsS: 5 mins

10 mins

15 mins

Respiratory disease

Vector bornedisease

Hepatitis

Cardiac marker

Inflammation

Chronic disease

Hormone

Tumor marker

Sampletype

Samplevolume

Time toresult Type

Test/kit

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 sales@sdbiosensor.com Website www.sdbiosensor.comLEF-FSYST-EN / SDC.1710 © 2017 SD BIOSENSOR. All rights reserved.

STANDARD F Fluorescent Imm

unoassay System

HIV-1/2 Ab, HBsAg, Adenovirus Ag, C. difficile A/B GDH, Vitamin D, Cystatin C, AFP, CEA, FOB, LH, T3, T4

STANDARD F Controls

Available Soon

Cat No. Description Test/kit

Influenza A/B Control

RSV Ag Control

Strep A Ag Control

Legionella Ag Control

S.pneumoniae Ag Control

10INFC10

10RSVC10

10STRC10

10LEGC10

10SPNC10

10T / kit

10T / kit

10T / kit

10T / kit

10T / kit

Cat No. Description Test/kit

SDB HbA1c Control

U-Albumin Control

SDB CRP Control

PCT Control

03ACS10

10UALC10

03CCS10

10PCTC10

10T / kit

10T / kit

10T / kit

10T / kit

S/PTSH FIA10TSH10B 15 mins