WHO WE ARE
• Young Turkish biotechnology company that operates
under ISO 9001:2008, ISO 13485:2005, and
European Commision Directive 98/79/EC Full Quality
Assurance Systems.
• Main expertise: Designing,
developing and manufacturing
Real-Time PCR kits, nucleic acid
extraction kits and automated
nucleic acid extraction instruments.
• Creating turnkey solutions for Real-Time PCR applications
with IVD CE certificated List A and List B pathogen detection
kits including HBV, HCV, HDV, CMV and HIV.
• Collaboration with universities and hospitals, for Anatolia R&D
projects which are supported by TUBITAK (The Scientific and
Technological Research Council of Turkey).
• Solution oriented efficient products thanks to the
interdisciplinary collaboration of the partners and
colleagues; from medicine, genetics, molecular biology,
bioengineering, biology, mechatronics engineering,
electronic engineering, and mechanical engineering.
• Aim to manufacture highest quality products with
reasonable prices.
• Class 1000 laboratory for R&D and kit production via
robotic liquid handlers, the high sensitivity, linearity and
consistency of the products are guaranteed long before
the strict quality controls according to ISO 13485:2005 and
the requirements of Annex IV of the Directive 98/79/EC.
WHAT IS A CE MARK?
A European Commission mark which indicates that a
product is safe, and will not harm human health or the
environment if it is used in conformity with its intended
use.
(CE: Conformité Européenne)
WHICH PRODUCTS REQUIRE CE
MARKING?
23 product categories in total (Toys, elevators, boilers, boats,
medical devices, telecommunication devices, etc...)
Every category has a separate and specific Directive with
different requirements, such as:
•Low Voltage Electrical Equipment: EEC Council Directive
73/23/EEC
•Medical Devices: 93/42/EEC Directive
•In Vitro Diagnostic Medical Devices: 98/79/EC Directive
CE MARKING REQUIRED FOR
MOLECULAR GENETICS SYSTEMS
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 27 October 1998
on in vitro diagnostic medical devices
In Vitro Diagnostic Medical Devices: IVD CE MARK
Must NOT Be Confused With Electrical CE mark!
CE marking is specific to the product not the company!
CLASSIFICATION ACCORDING TO 98/79/EC IVDMD DIRECTIVE
Annex II – High Risk IVD Devices
List A Products: (Notified Body Certification&Surveillance Obligatory)
–HBV, HCV, HDV, HIV, HTLV, ABO, Rh Anti-Kell blood group
List B Products: (Notified Body Certification&Surveillance Obligatory)
–CMV, C. trachomatis, C. Pneumoniae, Rubella, toxoplasmosis
–Anti-Duffy, Anti-Kidd blood group, Anti-erythrocytic antibodies
–Phenylketonuria, HLA tissue groups, PSA tumoral markers, Trisomy 21, Blood sugar measurement devices
Products not Included in Annex II: (Self-Declaration, Notified Body Certification and Surveillance Not Necessary)
-All other IVD Products
Notified
Body
Code
Self Declaration
CE Mark
CE Mark authorized by
a Notified Body
Notified Body
Code
NOTIFIED BODY
• Institution authorized by the
European Parliament For the
Certification of List A & List B
Products
• Equal authorization level
• Exactly same applied directives,
certification and inspection
procedures
• List of Authorized Notified Bodies
in European Commision Web Site:
http://ec.europa.eu/enterprise/newapp
roach/nando/index.cfm?fuseaction
=directive.notifiedbody&dir_id=20&t
ype_dir=NO
CE MARKING PROCEDURES
PRE-AUDIT
BATCH RELEASE &
SALES
AUDIT
DECLARATION OF
CONFORMITY
LOT
VERIFICATION
DETERMINING
THE RISK LEVEL &
ROUTE*
For each lot in case
of List A products!
CERTIFICATION
*Route for Anatolia Geneworks:Full QualityAssurance System
Annex IV of the Directive 98/79/EC
List A & List B
Products
+ Annual Audits &
Continuous
Inspection
SELF
DECLARATION OF
CONFORMITY
Products not
Included in Annex
II
SALES
(No inspection, audit or
control by a Notified
Body, Self Guarantee
by the Manufacturer)
PCR LICENSE
• Not a quality certificate
• Not a warranty of safety
• Related to patent rights, a contract between the
patent holders and manufacturers
• Was only valid during the patent period in limited
countries
• Main PCR patent has expired and no PCR license
exists anymore
• Abused by manufacturers once acquired this
license
• No benefits for the end users
CAT.NO PRODUCT
REAL TIME PCR SYSTEMS & KITSRT-010 Montania 483 Real-Time PCR Instrument
RT-020 Montania 4896 Real-Time PCR Instrument
ABHBV3 Bosphore HBV Quantification Kit v1 (100 Rxn/Box)
ABHBV6 Bosphore HBV Quantification Kit v2 Single Mix (100 Rxn/Box)
ABHCV3 Bosphore HCV Quantification Kit v1 (100 Rxn/Box)
ABHCV6 Bosphore HCV Quantification Kit v2 Single Mix (100 Rxn/Box)
ABHIV3 Bosphore HIV-1 Quantification Kit v1 (100 Rxn/Box)
ABHIV6 Bosphore HIV-1 Quantification Kit v2 Single Mix (100 Rxn/Box)
ABHDV3 Bosphore HDV Quantification Kit v1 (100 Rxn/Box)
ABHDV6 Bosphore HDV Quantification Kit v2 Single Mix (100 Rxn/Box)
ABCMV3 Bosphore CMV Quantification Kit v1 (100 Rxn/Box)
ABCMV6 Bosphore CMV Quantification Kit v2 Single Mix (100 Rxn/Box)
ABCTR3 Bosphore Chlamydia trachomatis Quantification Kit v1 (100 Rxn/Box)
ABHCG3 Bosphore HCV Genotyping Kit v1 (100 Rxn/Box)
ABHPD3 Bosphore HPV Detection Kit v1 (100 Rxn/Box)
ABHPG3 Bosphore HPV Genotyping Kit v1 (100 Rxn/Box)
ABMTB3 Bosphore MTBC Quantification Kit v1 (100 Rxn/Box)
ABTBD3 Bosphore MTBC Detection Kit v1 (100 Rxn/Box)
ABPRV3 Bosphore Parvovirus B19 Quantification Kit v1 (100 Rxn/Box)
ABJCV3 Bosphore JCV Quantification Kit v1 (100 Rxn/Box)
ABBKV3 Bosphore BKV Quantification Kit v1 (100 Rxn/Box)
ABJKV3 Bosphore JCV-BKV Detection Kit v1 (100 Rxn/Box)
ABEBV3 Bosphore EBV Quantification Kit v1 (100 Rxn/Box)
ABHSV3 Bosphore HSV 1-2 Genotyping Kit v1 (100 Rxn/Box)
ABBRC3 Bosphore Brucella Detection Kit v1 (100 Rxn/Box)
ABWNV3 Bosphore West Nile Virus Quantification Kit v1 (100 Rxn/Box)
ABCCH3 Bosphore CCHFV Quantification Kit v1 (100 Rxn/Box)
ABHPY3 Bosphore Helicobacter Pylori Detection Kit v1 (100 Rxn/Box)
ABHPG3 Bosphore Helicobacter Pylori Genotyping Kit v1 (100 Rxn/Box)
ABURP3 Bosphore Ureaplasma urealyticum Quantification Kit v1 (100 Rxn/Box)
ABTXP3 Bosphore Toxoplasma gondii Detection Kit v1 (100 Rxn/Box)
ABTTV3 Bosphore TTV Quantification Kit v1 (100 Rxn/Box)
PRODUCTS FOR
PATHOGEN
TESTING
PRODUCTS FOR GENETIC TESTING
ABFVL3 Bosphore FVL Detection Kit v1 (100 Rxn/Box)
ABJAK3 Bosphore JAK2 Detection Kit v1 (100 Rxn/Box)
ABPRO3 Bosphore Prothrombin Detection Kit v1 (100 Rxn/Box)
AB6773 Bosphore MTHFR C677T Detection Kit v1 (100 Rxn/Box)
AB1293 Bosphore MTHFR A1298C Detection Kit v1 (100 Rxn/Box)
ABB273 Bosphore HLA B27 Detection Kit v1 (100 Rxn/Box)
ABPAI3 Bosphore PAI-1 4G/5G Detection Kit v1 (100 Rxn/Box)
ABFVC3 Bosphore FVC Detection Kit v1 (100 Rxn/Box)
PRODUCTS FOR FOOD TESTING
GMO & MEAT SPECIES IDENTIFICATION REAL TIME PCR KITS ( WITH IC )ABNOS3 Bosphore tNOS GMO Detection Kit v1 (100 Rxn/Box)
ABS353 Bosphore S35 GMO Detection Kit v1 (100 Rxn/Box)
ABSOS3 Bosphore S35-tNOS GMO Identification Kit v1 (100 Rxn/Box)
ABPOR3 Bosphore Pork Identification Kit v1 (100 Rxn/Box)
ABBOV3 Bosphore Bovine Identification Kit v1 (100 Rxn/Box)
ABTUR3 Bosphore Turkey Identification Kit v1 (100 Rxn/Box)
ABCHI3 Bosphore Chicken Identification Kit v1 (100 Rxn/Box)
ABSHE3 Bosphore Sheep Identification Kit v1 (100 Rxn/Box)
ABGOA3 Bosphore Goat Identification Kit v1 (100 Rxn/Box)
ABTUR3 Bosphore Dog Identification Kit v1 (100 Rxn/Box)
ABDON3 Bosphore Donkey Identification Kit v1 (100 Rxn/Box)
ABHOR3 Bosphore Horse Identification Kit v1 (100 Rxn/Box)
ABPTC3 Bosphore Poultry (Turkey-Chicken) Identification Kit v1 (100 Rxn/Box)
ABHBP3 Bosphore Halal (Bovine-Pork) Identification Kit v1 (100 Rxn/Box)
PRODUCTS FOR DNA/RNA EXTRACTION AUTOMATED NUCLEIC ACID EXTRACTION SYSTEM & KITS
DE-010 Magnesia16 Nucleic Acid Extraction Instrument
AE1012 Magnesia16 Whole Blood Genomic DNA Extraction Kit QS (96 Strips/Box)
AE1022 Magnesia16 Whole Blood Genomic DNA Extraction Kit (96 Strips/Box)
AE1042 Magnesia16 Whole Blood Genomic DNA Extraction Kit LV-1200 µl (96 Strips/Box)
AE1102 Magnesia16 Cultured Cells Genomic DNA Extraction Kit (96 Strips/Box)
AE2012 Magnesia16 Viral DNA/RNA Extraction Kit (96 Strips/Box)
AE2022 Magnesia16 Viral DNA/RNA Extraction Kit EP (96 Strips/Box)
AE2102 Magnesia16 Viral DNA/RNA Extraction Kit LV-2400 µl (96 Strips/Box)
AE2112 Magnesia16 Viral DNA/RNA Extraction Kit LV-1200 µl (96 Strips/Box)
AE3012 Magnesia16 Plant Genomic DNA Extraction Kit (96 Strips/Box)
AE4012 Magnesia16 Tissue Genomic DNA Extraction Kit (96 Strips/Box)
AE5022 Magnesia16 Bacterial (Gram +/-) DNA Extraction Kit (96 Strips/Box)
AE6012 Magnesia16 Whole Blood Total RNA Extraction Kit (96 Strips/Box)
HIGH THROUGHPUT AUTOMATED NUCLEIC ACID EXTRACTION SYSTEM & KITSDE-020 Magnesia4896 Nucleic Acid Extraction & PCR Setup Robot
AE96V1 Magnesia4896 Viral DNA/RNA Extraction Kit ( 96 Extractions)
MANUAL SPIN COLUMN NUCLEIC ACID EXTRACTION KITS
ABXTD1 Bosphore Tissue Genomic DNA Extraction Spin Kit
ABXVD1 Bosphore Viral DNA Extraction Spin Kit (100 Extraction)
ABXVR1 Bosphore Viral RNA Extraction Spin Kit (100 Extraction)
ABXGD1 Bosphore Whole Blood Genomic DNA Extraction Spin Kit
ABXBD1 Bosphore Bacterial DNA Extraction Spin Kit
MANUAL MAGNETIC BEAD NUCLEIC ACID EXTRACTION STAND & KITS AEMB24 Magnesia Manual Magnetic Bead Nucleic Acid Extraction Stand For 24 Samples
AEMDR1 Magnesia Manual Magnetic Bead Viral DNA/RNA Extraction Kit
OUR SALES TERRITORIES
EUROPE
•Austria, Czech Republic, Turkey, Poland
ASIA
•Iran, Iraq, India, Jordan, Pakistan, Vietnam,
Yemen
AFRICA
•Djibouti, Egypt, Kenya
• XXXIV. Turkish Microbiology Congress, 2010, Turkey
• Arab Health 2011, Dubai, U.A.E.
• 1st National Clinical Microbiology Congress, 2011,
Turkey
• Medica 2011, Düsseldorf, Germany
• ArabLab 2012, Dubai, U.A.E.
EXHIBITIONS & CONGRESSES
• DNA is amplified using fluorescent probes to measure
fluorescent signal and is monitored during the amplification
• No need for visualization techniques after PCR ( gel
electrophoresis etc.)
• Higher sensitivity and wide dynamic range
• Quantitative results for infectious diseases
• Reproducible and reliable results
• Practical and ready-to-use kits are available
• No problems specific to Agarose Gel Electrophoresis and
staining, such as:
• poor separation
• low sensitivity and dynamic range
• separation based only on length of PCR products/DNA
REAL-TIME PCR & CONVENTIONAL PCR
End point measurement is not quantitative!
3 cycle = 8 times difference
REAL-TIME PCR & CONVENTIONAL PCR
Plateau phase
Log-linear phase
Early
exponential
phase Linear ground phase
REAL-TIME PCR & CONVENTIONAL PCR
Detection phase in
Real-Time PCR
Detection phase in
conventional PCR
Exponential phase: Rxn is specific and precise.
Linear phase: Rxn building blocks are being spent, rxn is slowing down and the
products begin to degrade.
Plateau phase: Rxn stops, new product synthesis ends.
2 samples (duplicates) with the same DNA amount is amplified in
similar pattern at the beginning of reaction, when reagents are fresh.
DNA amount is doubled in each cycle (exponential phase). Later,
they tend to vary as reagents are used. At the end, reaction reaches
plateau due to consumption of reagents.
REAL-TIME PCR & CONVENTIONAL PCR
Taq Q
Q Degraded probe Fluorescence detection!
Q F Primer-R
Primer-F
No Fluorescence! (Blocked/Quenched)
DUAL LABELED PROBE BASED REAL-TIME PCR ANNEALING/ELONGATION STAGE
PRODUCTS AT A GLANCE
Bosphore® Real-Time PCR Kits
IVD CE mark for List A & List B products (HBV, HCV, HDV, HIV,
CMV) (in accordance with 98/79/EC European Commision
Directive Full Quality Assurance )
Ready-to-use kits (no additional enzyme or control are required)
Dual labeled, sequence specific probes for high specificity
Quantitation Standards are calibrated against World Health
Organization (WHO) NAT standards Provided as serum to
undergo the same steps as the patient samples (List A products)
Bosphore® Real-Time PCR Kits
High sensitivity and reproducibility
Versions for single mix for more practical use and UNG
against PCR product contamination
Internal control that covers the extraction step
Pathogen detection kits encompasses all the strains,
subtypes all over the world
Prompt customer support by molecular biologists with
Ph.D. or M.Sc. degrees
Development of new products depending on the market
demand
PRODUCTS AT A GLANCE
Magnesia® Automated DNA/RNA Extraction Kits
Magnetic extraction method, for a wide variety of samples
Both viral DNA and viral RNA can be extracted using the
same kit
Ready-to-use sealed cartridges
High yield and sensitivity: Upto 40µg/ml genomic DNA from
blood yield. Upto 5.7 µg/ml total RNA from blood
Extraction from a wide variety of samples, for various
downstream assays
Variable starting volumes from 200 ul upto 2.4 ml, enables
high sensitivity and pooling applications
Bosphore® Manual Spin Column DNA/RNA Extraction
Kits
High yield and sensitivity
Cost efficient
PRODUCTS AT A GLANCE
KITS AT A GLANCE
Kit
98/79/E
C Annex
II
Quantitative/
Qualitative
Genotypes
Detected
Analytical
detection
limit
Standard
Supplied
As
Conversion
Factor
HBV List A Quantitative A,B,C,D,E,F,G,H
and all subtypes 10 IU/ml Serum
1 IU=4.5
copies/ml
HCV List A Quantitative 1,2,3,4,5,6 and
all subtypes 25 IU/ml
Serum 1 IU=3
copies/ml
HIV-1 List A Quantitative HIV-1 50 IU/ml Serum 1IU=0.7
copies/ml
CMV List B Quantitative All genotypes 50 IU/ml DNA 1IU/ml=1.2
copies/ml
Parvo Non-
listed Quantitative All genotypes 75 IU/ml DNA
MTBC Non-
listed
Quantitative
and
Qualitative
Mycobacterium
tuberculosis
complex
M.
tuberculosis,M.
bovis ,M. bovis
BCG ,M.
africanum ,M.
canetti ,M.
caprae ,M.
microti ,M.
pinnipedii
128
copies/ml DNA
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