STANDARD F Fluorescent Immunoassay System F... · 2019. 1. 3. · Chikungunya IgM/IgG FIA 10CKM10B...
Transcript of STANDARD F Fluorescent Immunoassay System F... · 2019. 1. 3. · Chikungunya IgM/IgG FIA 10CKM10B...
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 [email protected] 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