GB OASYS

Page 1

LOCATIONS TAIWAN: HSINCHU (Headquartered) No.6, Innovation First Rd, Hsinchu Science Park, Taiwan R.O.C. KAOHSIUNG 3F., No.61, Luke 2nd Rd., Luzhu Dist., Kaohsiung City 821, Taiwan R.O.C. TAOYUAN No.168, Jingguo Rd., Taoyuan City, Taoyuan County 330, Taiwan R.O.C. TAICHUNG No.117, Shatian Rd., Shalu Dist., Taichung City 433, Taiwan R.O.C. NORTH AMERICA: IRVINE 5410 Trabuco Rd. Suite 130 Irvine, CA 92620 USA VANCOUVER 701 West Georgia St. Suite 1500. Vancouver, B.C. V7Y-1C6, Canada

E sales.group@gbc.com.tw T +886 3 577 9221 F +886 3 577 9227 www.gbc.com.tw

Your Liver. We Care.


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

General Biologicals Corporation

Integrity . Integration . Intellection . Innovation BACKGROUND

General Biologicals Corporation (GBC), founded in 1984, is the industry-leading in-vitro diagnostic device manufacturer in Taiwan.

AWARDS

2000

2000 National Biotechnology Medical Golden Prize

2001

Small and Medium Enterprise Innovation Research Award

2006

BIo-Taipei Award for R&D Collaboration with NTUH

2010

2010 SCB Elite Award

2011

The 9th Annual Taiwan Golden Root Award

2012

Industrial Innovation Achievement Award - BioFibroScore™ Innovation

GBC is certified with IVD Class III, GMP and ISO 13485:2003. GBC has offices in Taipei, Hsin-Chu, Kaohsiung (Taiwan), Irvine (USA), and Vancouver (Canada).

GBC developed a wide spectrum of technology platform in various diagnostics products such as Raw Materials (antibody & antigen), Radioimmunoassay (RIA), Enzyme-linked Immunoassay (ELISA), Point-of-Care Test (POCT) and Real-Time Polymerase Chain Reaction (RT-PCR). In addition, GBC has its own intensive sequential vertical technology platform of hybridoma techniques, cell culture, genetic engineering, protein purification and peptide synthesis, assay, coating, fill-in and labeling.

MILESTONE

1998

2008

2009

2010

2012

C ant Qu AFP

Bio

Fib

roS c

ore

itat ive

PO

it CR K ant ™P lQu Rea

Qu a Dia ntitat i g Pla nost ve Mo ics tfor l m Tec ecula hno r log y

gen t ELI S Poi A Kit nt o s a n fC are d Rea

SA)

s

1990

Enz Imm yme-l in Tec unoa ked hno ssa log y (E y LI

Rad Tec ioimm hno u log noass yP latf ay (R orm IA)

1984


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

General Biologicals Corporation

Integrity . Integration . Intellection . Innovation BACKGROUND

General Biologicals Corporation (GBC), founded in 1984, is the industry-leading in-vitro diagnostic device manufacturer in Taiwan.

AWARDS

2000

2000 National Biotechnology Medical Golden Prize

2001

Small and Medium Enterprise Innovation Research Award

2006

BIo-Taipei Award for R&D Collaboration with NTUH

2010

2010 SCB Elite Award

2011

The 9th Annual Taiwan Golden Root Award

2012

Industrial Innovation Achievement Award - BioFibroScore™ Innovation

GBC is certified with IVD Class III, GMP and ISO 13485:2003. GBC has offices in Taipei, Hsin-Chu, Kaohsiung (Taiwan), Irvine (USA), and Vancouver (Canada).

GBC developed a wide spectrum of technology platform in various diagnostics products such as Raw Materials (antibody & antigen), Radioimmunoassay (RIA), Enzyme-linked Immunoassay (ELISA), Point-of-Care Test (POCT) and Real-Time Polymerase Chain Reaction (RT-PCR). In addition, GBC has its own intensive sequential vertical technology platform of hybridoma techniques, cell culture, genetic engineering, protein purification and peptide synthesis, assay, coating, fill-in and labeling.

MILESTONE

1998

2008

2009

2010

2012

C ant Qu AFP

Bio

Fib

roS c

ore

itat ive

PO

it CR K ant ™P lQu Rea

Qu a Dia ntitat i g Pla nost ve Mo ics tfor l m Tec ecula hno r log y

gen t ELI S Poi A Kit nt o s a n fC are d Rea

SA)

s

1990

Enz Imm yme-l in Tec unoa ked hno ssa log y (E y LI

Rad Tec ioimm hno u log noass yP latf ay (R orm IA)

1984


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

Power of OASYSTM

Chemiluminescence Immunoassay (CLIA)

Reagents

CLIA uses two important technologies: a label technology which determines reactive mode and separation technology which determines the sensitivity, accuracy, and precision of the reagents.

Tumor Markers

Drug Monitoring

Prenatal Screeing

TORCH

Ferritin

Cyclosporine A

AFP

Toxo IgG

AFP

Tacrolimus. FK506

Free β-HCG

Toxo IgM

CEA

Digoxin

PAPP-A

Rubella IgG

Inflammation Monitoring

Fertility

CMV IgG

PCT

FSH

CMV IgM

CRP

LF

HSV-1/2 IgG

HCG/β-HCG

HSV-2 IgG

PRL

HSV-1/2 IgM

Total PSA f-PSA

LABELING TECHNOLOGY

CA 125

Rubella IgM

Two types of labeling technologies are commonly used. One contains enzyme labels and the other non-

CA 153

enzyme small molecule labels. OASYSTM system applies ABEI labels. ABEI is a small non-enzyme molecule with

CA 199

special molecular formula to enhance stability in acid and alkaline buffer. ABEI chemical reaction can finish

PAP

Thyroid

with sodium hydroxide (NaOH) and Hyperoxide (H2O2) finishes the process in 3 seconds.

CA 50

TSH

Estradiol

CYFRA 21-1

T4

Free Estriol

CA 242

T3

Progesterone

CA 72-4

FT4

Testosterone

NSE

FT3

free Testosterone

S-100

TG

PAPP-A

TPA

TGA

PG I

TRAb

Infectious

PG II

TMA

HBsAg

SCCA

Anti-TPO

HBeAg

Rev T3

HBcAg

SEPARATION TECHNOLOGY OASYS

TM

uses Nano Magnetic Microbeads. Nano magnetic microbeads has been widely used in CLIA technol-

ogy. Compare with traditional separation technologies, Nano magnetic microbeads has four major advantages: It helps in enlarging the reaction area of antigens and antibodies to shorten the reaction time. Better and faster capture of the antigens and antibodies to enhance the sensitivity. As a liquid separation platform, it mixes thoroughly with reagents to significantly reduce inter-or intra-assay discrepancies.

Cardiac

Hepatic

Absorbs the antigens or antibodies through chemical reaction to enhance the accuracy.

CK-MB

HA

Troponin I

P III P N P

Myoglobin

C IV

NT-proBNP Aldosterone Angiotensin I Angiotensin II D-Dimer

OASYS TM 600

OASYS TM 1000

OASYS TM 2000

OASYS TM 2000 plus

HCV HIV Syphilis

EBV EBV EA IgG EBV EA IgA EBV VCA IgG EBV VCA IgM EBV VCA IgA EBV NA IgG Immunoglobulin IgM IgA IgE IgG

Bone Metabolism

Kidney Function

Laminin

Intact PTH

β2-MG

Cholyglycine

Calcitonin

Albumin

Glyco Metabolism C-Peptide

Osteocaicin 25-OH Vitamin D

Others GH

Insulin

Anemia

Cortisol

IGF-1

Vitamin B12

ACTH

ICA

Ferritin

DHEA-S

IAA

FA

Proinsulin GAD65


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

Power of OASYSTM

Chemiluminescence Immunoassay (CLIA)

Reagents

CLIA uses two important technologies: a label technology which determines reactive mode and separation technology which determines the sensitivity, accuracy, and precision of the reagents.

Tumor Markers

Drug Monitoring

Prenatal Screeing

TORCH

Ferritin

Cyclosporine A

AFP

Toxo IgG

AFP

Tacrolimus. FK506

Free β-HCG

Toxo IgM

CEA

Digoxin

PAPP-A

Rubella IgG

Inflammation Monitoring

Fertility

CMV IgG

PCT

FSH

CMV IgM

CRP

LF

HSV-1/2 IgG

HCG/β-HCG

HSV-2 IgG

PRL

HSV-1/2 IgM

Total PSA f-PSA

LABELING TECHNOLOGY

CA 125

Rubella IgM

Two types of labeling technologies are commonly used. One contains enzyme labels and the other non-

CA 153

enzyme small molecule labels. OASYSTM system applies ABEI labels. ABEI is a small non-enzyme molecule with

CA 199

special molecular formula to enhance stability in acid and alkaline buffer. ABEI chemical reaction can finish

PAP

Thyroid

with sodium hydroxide (NaOH) and Hyperoxide (H2O2) finishes the process in 3 seconds.

CA 50

TSH

Estradiol

CYFRA 21-1

T4

Free Estriol

CA 242

T3

Progesterone

CA 72-4

FT4

Testosterone

NSE

FT3

free Testosterone

S-100

TG

PAPP-A

TPA

TGA

PG I

TRAb

Infectious

PG II

TMA

HBsAg

SCCA

Anti-TPO

HBeAg

Rev T3

HBcAg

SEPARATION TECHNOLOGY OASYS

TM

uses Nano Magnetic Microbeads. Nano magnetic microbeads has been widely used in CLIA technol-

ogy. Compare with traditional separation technologies, Nano magnetic microbeads has four major advantages: It helps in enlarging the reaction area of antigens and antibodies to shorten the reaction time. Better and faster capture of the antigens and antibodies to enhance the sensitivity. As a liquid separation platform, it mixes thoroughly with reagents to significantly reduce inter-or intra-assay discrepancies.

Cardiac

Hepatic

Absorbs the antigens or antibodies through chemical reaction to enhance the accuracy.

CK-MB

HA

Troponin I

P III P N P

Myoglobin

C IV

NT-proBNP Aldosterone Angiotensin I Angiotensin II D-Dimer

OASYS TM 600

OASYS TM 1000

OASYS TM 2000

OASYS TM 2000 plus

HCV HIV Syphilis

EBV EBV EA IgG EBV EA IgA EBV VCA IgG EBV VCA IgM EBV VCA IgA EBV NA IgG Immunoglobulin IgM IgA IgE IgG

Bone Metabolism

Kidney Function

Laminin

Intact PTH

β2-MG

Cholyglycine

Calcitonin

Albumin

Glyco Metabolism C-Peptide

Osteocaicin 25-OH Vitamin D

Others GH

Insulin

Anemia

Cortisol

IGF-1

Vitamin B12

ACTH

ICA

Ferritin

DHEA-S

IAA

FA

Proinsulin GAD65


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

Technical Specification System

OASYSTM 600

OASYSTM 2000

OASYSTM 2000 plus

• Non-enzyme involved flash chemiluminescence, long stability of reagents • Starter reagents consists of NaOH and H2O2, not affected by storage conditions • ABEI label, stable in acid and alkaline buffers

Type

• 24 hours ready to use • Time to first result:17 minutes

Throughput • Up to 180 tests/h

Operation Modes

Sample Loading

OASYSTM 1000

• Up to 120 tests/h

• Up to 180 tests/h

• Up to 180 tests/h

• Up to 144 primary tubes • Continuous loading, STAT available • Barcode reader recognition or analyzer auto numbered • Refrigerated sample area with independent power supply

• Up to 144 primary tubes • Continuous loading, STAT available • Barcode reader recognition or analyzer auto numbered • Refrigerated sample area with independent power supply

• 15 reagents on board

• 25 reagents on board

• Random, Batch and STAT function

• Up to 16 primary tubes • Continuous loading, STAT available • Analyzer auto numbered

• Up to 144 primary tubes • Continuous loading, STAT available • Analyzer auto numbered

• Continuous loading • RFID reads all reagent info automatically • Refrigerated reagent area

Reagent Loading • 4 reagents on board

• 15 reagents on board

Reagent Features

• Integrated kit with calibrator ready to use • Use superparamagnetic micrbeads • RFID tag storing all reagent info

• RFID tag with built-in master curve • 2-point calibration to adjust master curve • Calibration stability: max 4 weeks

Other Features

• Clot detection • Monitor for liquid level of reagent • Optional ratio for sample dilution

• Auto dilution for high titer sample • Constant 37� incubation • 15-30� room working temperature

Operation System

• Windows XP • HP compatible • Color touch screen • Connection to LIS via COM or network card • Direct operation on LIS system to test

Interconnection Dimensions Weight

• 88×56×50cm, 56kg

• 135×64×87cm, 148kg

• 135×64×87cm, 158kg

• 144×76×152cm, 228kg


Industry-Leading In-Vitro Diagnostic Device Manufactuer

Your Liver. We Care.

Technical Specification System

OASYSTM 600

OASYSTM 2000

OASYSTM 2000 plus

• Non-enzyme involved flash chemiluminescence, long stability of reagents • Starter reagents consists of NaOH and H2O2, not affected by storage conditions • ABEI label, stable in acid and alkaline buffers

Type

• 24 hours ready to use • Time to first result:17 minutes

Throughput • Up to 180 tests/h

Operation Modes

Sample Loading

OASYSTM 1000

• Up to 120 tests/h

• Up to 180 tests/h

• Up to 180 tests/h

• Up to 144 primary tubes • Continuous loading, STAT available • Barcode reader recognition or analyzer auto numbered • Refrigerated sample area with independent power supply

• Up to 144 primary tubes • Continuous loading, STAT available • Barcode reader recognition or analyzer auto numbered • Refrigerated sample area with independent power supply

• 15 reagents on board

• 25 reagents on board

• Random, Batch and STAT function

• Up to 16 primary tubes • Continuous loading, STAT available • Analyzer auto numbered

• Up to 144 primary tubes • Continuous loading, STAT available • Analyzer auto numbered

• Continuous loading • RFID reads all reagent info automatically • Refrigerated reagent area

Reagent Loading • 4 reagents on board

• 15 reagents on board

Reagent Features

• Integrated kit with calibrator ready to use • Use superparamagnetic micrbeads • RFID tag storing all reagent info

• RFID tag with built-in master curve • 2-point calibration to adjust master curve • Calibration stability: max 4 weeks

Other Features

• Clot detection • Monitor for liquid level of reagent • Optional ratio for sample dilution

• Auto dilution for high titer sample • Constant 37� incubation • 15-30� room working temperature

Operation System

• Windows XP • HP compatible • Color touch screen • Connection to LIS via COM or network card • Direct operation on LIS system to test

Interconnection Dimensions Weight

• 88×56×50cm, 56kg

• 135×64×87cm, 148kg

• 135×64×87cm, 158kg

• 144×76×152cm, 228kg


LOCATIONS TAIWAN: HSINCHU (Headquartered) No.6, Innovation First Rd, Hsinchu Science Park, Taiwan R.O.C. KAOHSIUNG 3F., No.61, Luke 2nd Rd., Luzhu Dist., Kaohsiung City 821, Taiwan R.O.C. TAOYUAN No.168, Jingguo Rd., Taoyuan City, Taoyuan County 330, Taiwan R.O.C. TAICHUNG No.117, Shatian Rd., Shalu Dist., Taichung City 433, Taiwan R.O.C. NORTH AMERICA: IRVINE 5410 Trabuco Rd. Suite 130 Irvine, CA 92620 USA VANCOUVER 701 West Georgia St. Suite 1500. Vancouver, B.C. V7Y-1C6, Canada

E sales.group@gbc.com.tw T +886 3 577 9221 F +886 3 577 9227 www.gbc.com.tw

Your Liver. We Care.


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