ANATOLIA GENEWORKS®

REAL-TIME PCR

&

NUCLEIC ACID EXTRACTION

SYSTEMS AND KITS

S010v1

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

Thanks for your attention ...