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. NORTH AMERICA: 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
2010
2012
C
2009
ive
™
AFP
Qu
ant
itat
ore roS c Fib Bio
lQu
ant
™P
CR
PO
Kit
2008
Rea
gen ELI S Poi A Kit nt o s f C and R are ea
SA)
Qu a Dia ntitat i g Pla nost ve Mo ics tfor l m Tec ecula hno r log y
1998 ts
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
2010
2012
C
2009
ive
™
AFP
Qu
ant
itat
ore roS c Fib Bio
lQu
ant
™P
CR
PO
Kit
2008
Rea
gen ELI S Poi A Kit nt o s f C and R are ea
SA)
Qu a Dia ntitat i g Pla nost ve Mo ics tfor l m Tec ecula hno r log y
1998 ts
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.
GB GenesisTM e1000
GB GenesisTM s1000
DNA/RNA Extraction System
FEATURES Touch Button - simplicity
DNA/RNA Extraction System
GB GENESIS TM e1000
GenesisTM S Series is the synonym of multifunctional DNA/RNA purification system. GenesisTM s1000 provides following functions:
GB GENESIS TM s1000
Barcode documentation: All tracking information can be exported as the excel file for every run. Protocol and programs can be updated through USB.
Rapid Results - about 30 minutes Flexible Design - single sample can be ran without wasting time
Sample aliquotting: Aliquot samples from various sizes of the primary tube with different sampling volumes (100 µL / 1000 µL) with sample level detection.
Batch Purify - 16 samples at one time Variety of Purification - Whole blood, plant, bacteria, tissue, culture cells, viral
Nucleic acid purification: Speed up and standardize the workflow to get pure, intact nucleic acid product in the absence of contamination.
DNA Economical Pricing - reagents and instrument
AVOIDING CROSS CONTAMINATION DESIGN
PCR setup: Multiple PCR setup; facilitate the lengthy PCR setup procedures and minimize the cross-contamination.
Independent Channel: Pipetting system and disposable accessories for each independent channel provide cross-contamination free. UV Sterilization: UV button is designed to turn on UV Lamp while your GenesisTM e1000 needs to be sterilized after running contagious samples. Cartridge Design: GenesisTM e1000 reagent cartridges are pre-sealed incorporating all reagents needed for the purification process. Patented Heating Well and Separation Well in the cartridge provide strong circulate force for Binding/Washing steps and give high purity in final eluent. Tip Design: The unique design of Tip-end with cross notch, provides precise buffer volume at pipetting steps, and without dead volume.
Model # of Samples Throughput
GenesisTM s1000 48 1-48 - Barcode tracking - Sampling from primary tube
Function
- DNA/RNA purification - Master mix perp - PCR Setup - Dual(6+1) channel pipettes
Working volume
- 5-1000 µL - 2-250 µL
Processing time
80 minutes
Industry-Leading In-Vitro Diagnostic Device Manufactuer
Your Liver. We Care.
GB GenesisTM e1000
GB GenesisTM s1000
DNA/RNA Extraction System
FEATURES Touch Button - simplicity
DNA/RNA Extraction System
GB GENESIS TM e1000
GenesisTM S Series is the synonym of multifunctional DNA/RNA purification system. GenesisTM s1000 provides following functions:
GB GENESIS TM s1000
Barcode documentation: All tracking information can be exported as the excel file for every run. Protocol and programs can be updated through USB.
Rapid Results - about 30 minutes Flexible Design - single sample can be ran without wasting time
Sample aliquotting: Aliquot samples from various sizes of the primary tube with different sampling volumes (100 µL / 1000 µL) with sample level detection.
Batch Purify - 16 samples at one time Variety of Purification - Whole blood, plant, bacteria, tissue, culture cells, viral
Nucleic acid purification: Speed up and standardize the workflow to get pure, intact nucleic acid product in the absence of contamination.
DNA Economical Pricing - reagents and instrument
AVOIDING CROSS CONTAMINATION DESIGN
PCR setup: Multiple PCR setup; facilitate the lengthy PCR setup procedures and minimize the cross-contamination.
Independent Channel: Pipetting system and disposable accessories for each independent channel provide cross-contamination free. UV Sterilization: UV button is designed to turn on UV Lamp while your GenesisTM e1000 needs to be sterilized after running contagious samples. Cartridge Design: GenesisTM e1000 reagent cartridges are pre-sealed incorporating all reagents needed for the purification process. Patented Heating Well and Separation Well in the cartridge provide strong circulate force for Binding/Washing steps and give high purity in final eluent. Tip Design: The unique design of Tip-end with cross notch, provides precise buffer volume at pipetting steps, and without dead volume.
Model # of Samples Throughput
GenesisTM s1000 48 1-48 - Barcode tracking - Sampling from primary tube
Function
- DNA/RNA purification - Master mix perp - PCR Setup - Dual(6+1) channel pipettes
Working volume
- 5-1000 µL - 2-250 µL
Processing time
80 minutes
Industry-Leading In-Vitro Diagnostic Device Manufactuer
Your Liver. We Care.
QIAGEN Rotor-Gene Q Real-Time PCR Cycler
Certified by GBC
QIAGEN ROTOR-GENE Q
QIAGEN's real-time PCR cycler, the Rotor-Gene Q, combines multiple optimized design features to provide the outstanding performance and reliable results that your research and clinical demands. Together with optimized GB RealQuant™ PCR Kits, the Rotor-Gene Q enables streamlined analysis for a wide range of applications. Outstanding thermal and optical performance due to rotary format An unmatched optical range spanning UV to infrared wavelengths State-of-the-art analyses supported by user-friendly software Low maintenance and maximum convenience due to robust design High performance in multiple applications with GB RealQuant™ PCR Kits
Industry-Leading In-Vitro Diagnostic Device Manufactuer
Your Liver. We Care.
QIAGEN Rotor-Gene Q Real-Time PCR Cycler
Certified by GBC
QIAGEN ROTOR-GENE Q
QIAGEN's real-time PCR cycler, the Rotor-Gene Q, combines multiple optimized design features to provide the outstanding performance and reliable results that your research and clinical demands. Together with optimized GB RealQuant™ PCR Kits, the Rotor-Gene Q enables streamlined analysis for a wide range of applications. Outstanding thermal and optical performance due to rotary format An unmatched optical range spanning UV to infrared wavelengths State-of-the-art analyses supported by user-friendly software Low maintenance and maximum convenience due to robust design High performance in multiple applications with GB RealQuant™ PCR Kits
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. NORTH AMERICA: 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.
GB HBV RealQuant™ PCR Kit
In-Vitro Quantification of Hepatitis B Virus DNA
FEATURES GB HBV RealQuant™ PCR is an in vitro real time polymerase chain reaction (PCR) kit for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals.
PERFORMANCE COMPARISON Correlation
Accuracy
GB HBV RealQuant™ PCR kit shows
Base on Clinical and Laboratory Standards
great result comparing with its compara-
Institute (CLSI) documents, the CV should
tor. Both GB HBV RealQuant™ PCR Kit
be less than 35%, and both Comparator
and its comparator show equivalency
HBV Test and GB HBV RealQuant™ PCR
(between
37~107
were passed. Both Comparator HBV Test
IU/mL).
and GB HBV RealQuant™ PCR were shown to be linear in serum across the range of WHO HBV DNA concentrations.
6 GBC
Correlation
log IU/mL
6
Target WHO Conc.
8
R2=0.966
4
2
Accuracy
log IU/mL
5
R2=0.955
4 3
R2=0.955
2 1 0
0 0
2
4
6
8
Comparator
10 log IU/mL
0
1
2
3
4
5
Target HBV Conc.
6 log IU/mL Comparator GB
Comparator
GB HBV RealQuant™ PCR
CT value & Conc.
CT value & Conc.
L1
N/A (>1.1x108 IU/mL)
9.52/3.31x109 IU/mL
L2
N/A (>1.1x108 IU/mL)
8.54/3.47x108 IU/mL
L3
7.58/3.80x107 IU/mL
7.63/4.27x107 IU/mL
Sample ID
Industry-Leading In-Vitro Diagnostic Device Manufactuer
Your Liver. We Care.
GB HBV REALQUANT™ PCR SPECIFICATION Certificates
TFDA / CE
Linear Range
10 IU~2.0E+09 IU/mL for 0.5mL input
LOD
9.8 IU/mL for 0.5mL input, 53 IU/mL for 0.2 mL input
Precision (CV%)
2.00 (log10IU/mL)=13.87%: 4.30 (log10IU/mL)=3.12%; 6.30 (log10IU/mL)=1.41%
Genotype Detection
A, B, C, D, E, F, G, wild types and mutants
Specimen Type
Serum and plasma
Time to Result
All processes including extraction within 3~4 hours (Manual or Automation)
Configuration
Master Mix, Primer, Probe, Internal Control, 5 Quantification Standard
Standardization
WHO International Standard for HBV DNA(97/746)
GB ANALYZER ECOSYSTEM GB GenesisTM e1000 DNA/RNA Extraction System GB GenesisTM s1000 DNA/RNA Extraction System GB GenesisTM s2000 DNA/RNA Extraction System QIAGEN Rotor-Gene Q - 2 channels RealTime PCR Cycler QIAGEN Rotor-Gene Q - 5 channels RealTime PCR Cycler
ORDERING INFORMATION Catalog No. 4HBPA2 S00340 S00341 S00352 S00343 S00353
Description GB HBV RealQuant™ PCR Kit GB Genesis™ e1000 GB Genesis™ s1000 GB Genesis™ s2000 QIAGEN Rotor-Gene Q - 2 channels QIAGEN Rotor-Gene Q - 5 channels
Package 48 tests/kit 1 unit 1 unit 1 unit 1 unit 1 unit 2013.Mar.
A No.6, Innovation First Road, Hsinchu Science Park, Taiwan, R.O.C. E sales.group@gbc.com.tw T +886 3 577 9221
www.gbc.com.tw
F +886 3 577 9227