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RB5 DetectionSimultaneous Detection of 5 Respiratory Bacteriaby Real-time PCR

Anyplex™Ⅱ

CE-IVD Marked

utilization of DPO™ and TOCE™ technologies

HIGH SENSITIVITY & SPECIFICITYSuperior

● Mycoplasma pneumoniae (MP)● Chlamydophila pneumoniae (CP)● Legionella pneumophila (LP)

● Bordetella pertussis (BP)● Bordetella parapertussis (BPP)

RB5

Features

a. Detection and differentiation of 5 respiratory bacteria in a single reaction b. Multiplex real-time PCR with high sensitivity and specificity by utilization of DPO™ and TOCE™ technologies c. Quantitative analysis by cyclic-CMTA d. Amenable to automated sample handling and assay systems e. Utilization of the UDG system to prevent carry-over contamination f. Internal Control for assay validity g. Convenient data interpretation by Seegene Viewer

Detection

Anyplex™ⅡⅡ

Compatible Instrumentation

• Auto Extraction & PCR setup

Seegene NIMBUS

Seegene STARlet

• Real-time PCR

CFX96™ Dx

Analytes

Result Seegene Viewer

Mycoplasma pneumoniae (MP), Chlamydophila pneumoniae (CP), and Legionella pneumophila (LP) are the most common causes of atypical pneumonia.1, 2) As these atypical pathogens do not respond to β-lactam antimicrobial therapy commonly used for bacterial community-acquired pneumonia (CAP),3) an accurate diagnosis beyond clinical assessment is critical in making decisions for optimal and effective treatment. Although a variety of diagnostic tests are available to assess such infections, culture and ELISA, routinely used techniques, are time-consuming, insensitive and often non-discriminating.4~6) By contrast, molecular diagnostic tests can rapidly discriminate the infectious agent with high sensitivity and specificity and thus these tests are important tools in the clinical laboratory.6~8) Development of multiplex molecular diagnostics for the simultaneous detection and discrimination of multiple pathogens that cause CAP has been anticipated as a major advancement in assessment and treatment.2,5,9~11)

Anyplex™ⅡRB5 Detection with Seegene’s proprietary TOCE™ technology can rapidly and simultaneously detects and differentiates CAP-related pathogens as well as two causative agents of whooping cough - Bordetella pertussis (BP) and Bordetella parapertussis (BPP) with both high sensitivity and specificity. By accurately detecting and differentiating pneumonia and whooping cough - causing bacteria, Anyplex™ⅡRB5 Detection test can help healthcare practitioners to apply the correct course of treatment for patients at the earliest possible stage.

• Mycoplasma pneumoniae (MP)

• Chlamydophila pneumoniae (CP)

• Legionella pneumophila (LP)

• Bordetella pertussis (BP)

• Bordetella parapertussis (BPP)

• Internal Control (IC)

Specimens

• Nasopharyngeal swab

• Nasopharyngeal aspirate

(CE-IVD Marked)

Quick and easy data analysis & interpretation

a . Interface specialized for multiplex testing

b. Interlocked with LIS

c. Patient information input via barcode scanning system or LIS system

d. Printable in various formats

e. Downloadable results in a CSV file

f . Convenient read out for quantitative analysis result

• Bronchoalveolar lavage

• Sputum (not applicable on Nimbus IVD & STARlet)

REALTIMEP C R M a r k e d

Performance related features1. Workflow - Accurate & Convenient Automated Platform

2. High multiplex quantitative analysis by cyclic-CMTA

3. Consistent Tm values despite genomic sequence variation

Reference

Analyte Accession No. (NCBI) Probe based Tm value (°C) TOCE™ based Tm value (°C)

M. pneumoniaeU60089

CP002077AP012303

69.462.069.7

64.5

L. pneumophila

JN700525JN380966GU083828GU083708

63.360.767.472.5

73

Automation via validated Nimbus IVD & STARlet IVD increases user convenience and decreases hands-on time.

Example Data in cyclic-CMTA points Result Interpretation

Atypical pathogens and respiratory tract infections. European Respiratory Journal, 2004;24:171-81.The atypical pneumonias: clinical diagnosis and importance. Clinical Microbiology and Infection, 2006;12(S3):S12-24.The bacterial etiology of community-acquired pneumonia in Korea: a nationwide prospective multicenter study. Infection & Chemotherapy, 2010;42:397-403.Molecular genetic methods in the diagnosis of lower respiratory tract infections. APMIS, 2004;112:713-27.Design of a multiplex PCR for Streptococcus pneumoniae,

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Haemophilus influenzae, Mycoplasma pneumoniae and Chlamydophila pneumoniae to be used on sputum samples. APMIS , 2005;113:99-111.Development of real-time multiplex nucleic acid sequence-based amplification for detection of Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Legionella spp. in respiratory specimens. Journal of Clinical Microbiology, 2008;46:185-91.Improved diagnosis of the etiology of community-acquired pneumonia with real-time polymerase chain reaction. Clinical Infectious Diseases, 2005;41:345-51.

Sample type is crucial to the diagnosis of Mycoplasma p n e u m o n i a e p n e u m o n i a by P C R . J o u r n a l o f M e d i c a l Microbiology, 2005; 54:287-91.BTS guidelines for the management of community acquired pneumonia in adults: Thorax, 2009;64(S3):iii1-55. BTS guidelines for the management of community acquired pneumonia in adults: Thorax, 2011 Jun;66(6):548-9. Epub Apr 17. BTS guidelines for the management of community acquired pneumonia in children: Thorax, 2011 Oct;66 Suppl 2:ii1-23.

Melting temperature differences are often observed in subtypes of pathogens that have sequence variation regions using probe based Tm analysis method.

These are critical limitations for routine applications toward clinical diagnosis field.

However, melting temperature is not affected by the sequence variation of pathogens by application of TOCE™ technology.Anyplex™Ⅱ RB5 Detection always guarantees accurate test results.

The Catcher-Tm can be measured repeatedly at 30, 40, and 50 cycles during the PCR process. The cyclic-CMTA results indicate that the patient are infected by B. parapertussis (BPP) with high concentration and B. pertussis (BP) with low concentration .

Analytes CMTA points

Interpretation1st

(cycle 30)2nd

(cycle 40)3rd

(cycle 50)

BP - - + + Low

BPP + + + +++ High

Real-time PCR

CFX96™

1st CMTA point (cycle 30) 2nd CMTA point (cycle 40) 3rd CMTA point (cycle 50)

(Result view in CFX96™ )

Auto Data Interpretation

Seegene Viewer

High Multiplex Real-time PCR

Real-time PCR

or

NIMBUS IVD STARlet IVD

Automated Extraction & PCR SetupSpecimen

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ENG

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RB75

-EN

2003

27B-

01

• Detection and differentiation of 5 respiratory bacteria in a single reaction • Multiplex real-time PCR with high sensitivity and specificity by utilization of DPO™ and TOCE™ technologies • Quantitative analysis by cyclic-CMTA• Amenable to automated sample handling and assay systems • Utilization of the UDG system to prevent carry-over contamination • Internal Control for assay validity • Convenient data interpretation by Seegene Viewer

RB5 DetectionAnyplex™Ⅱ

Instrument Type Cat. No.

CFX96™ DxReal-time PCR _ Optical Reaction Module 1845097-IVD

Real-time PCR _ Thermal Cycler 1841000-IVD

Seegene NIMBUS Automated extraction & PCR Setup 65415-03

Seegene STARlet Automated extraction & PCR Setup 67930-03

STARMag 96 X 4 Universal Cartridge kit Nucleic acids extraction reagent 744800.4.UC384

Ordering Information

Product Package Volume Cat. No.

Anyplex™Ⅱ RB5 Detection50 rxns RB7500Y

100 rxns RB7500X

Not Available for Sale in the United States

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