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STI-7 DetectionSimultaneous Detection of 7 STI Pathogensby Real-time PCR

Anyplex™Ⅱ

CE-IVD Marked

utilization of DPO™ and TOCE™ technologies

HIGH SENSITIVITY & SPECIFICITYSuperior

● Ureaplasma parvum (UP) ● Ureaplasma urealyticum (UU) ● Mycoplasma genitalium (MG)

● Mycoplasma hominis (MH) ● Trichomonas vaginalis (TV) ● Neisseria gonorrhoeae (NG)

● Chlamydia trachomatis (CT)

STI-7

Analytes

• Chlamydia trachomatis (CT)• Neisseria gonorrhoeae (NG)• Trichomonas vaginalis (TV)• Mycoplasma hominis (MH)• Mycoplasma genitalium (MG)• Ureaplasma urealyticum (UU)• Ureaplasma parvum (UP)• Internal Control (IC)

Features

a. Detection and differentiation of 7 major STI causing pathogens 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 the Seegene Viewer

Workflow - Accurate&convenient by automated platform

Detection

Anyplex™ⅡSTI-7 Detection is a high multiplex real-time PCR assay developed using the proprietary DPO™ & TOCE™ technologies. Anyplex™Ⅱ

STI-7 Detection can detect, differentiate and provide quantitative information concerning 7 pathogens causing sexually transmitted infections (STIs) from a single sample using real-time PCR.Real-time PCR is a highly sensitive diagnostic tool for detection of urogenital pathogens, especially for culture-difficult organisms. Quantitative results from real-time PCR can be useful to determine the disease severity1) and the possibility of transmission2). Higher bacterial loads of pathogens such as C. trachomatis1,3), M. genitalium4,5) and Ureaplasma spp.6), suggest infections rather than colonization. In the case of co-infections, quantitative results will help to determine optimal treatment.Anyplex™ⅡSTI-7 Detection represents a new class of multiplex molecular assays. Multiple quantitation of bacterial load by real-time PCR will facilitate a better understanding of bacterial pathogenesis and has the potential for providing information to guide patient management decisions, allowing true patient specific personalized management.

Anyplex™ⅡⅡ

Automated Extraction & PCR Setup Real-time PCRSpecimen

Automation via validated Nimbus IVD & STARlet IVD improves easy workflow and decreases hands-on time.

Auto Data Interpretation

Compatible Instrumentation

• Auto Extraction & PCR setup

Seegene NIMBUS

Seegene STARlet

• Real-time PCR

CFX96™ Dx

AB7500

Specimens

• Swab specimen (urethral, vaginal and cervical)

• Urine specimen

(CE-IVD Marked)

• Liquid based cytology specimen (e.g., ThinPrep® and Surepath™)

Seegene ViewerCFX96™

or

NIMBUS IVD STARlet IVD

REALTIMEP C R M a r k e d

Result

As sensitive as singleplex real-time PCR

Seegene Viewer

Quick and easy data analysis & interpretation

a . Interface specialized for multiplex testing

b. Interlocked with LIS

c. Patient information input via barcode scanning system

d. Printable in various formats

e. Downloadable results in a CSV file

f . Convenient read out for quantitative analysis result by cyclic-CMTA

High Multiplex Real-time PCR

High multiplex quantitative analysis by cyclic-CMTA

cyclic-CMTA points (Result view in CFX96™ (Bio-Rad))

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 carries Neisseria gonorrhoeae (NG) in an intermediate number of copies and Chlamydia trachomatis (CT) in a low number of copies.

Analytes

CMTA points

Interpretation1st

(cycle 30)2nd

(cycle 40)3rd

(cycle 50)

NG - + + ++ Intermediate

CT - - + + Low

Result

1st CMTA point (cycle 30)

300

250

200

150

100

50

50 60 70 80

0

-d(R

FU)/

dT

Melt peak

Temperature, Celsius

300

250

200

150

100

50

50 60 70 80

0

-d(R

FU)/

dT

Melt peak

Temperature, Celsius

300

250

200

150

100

50

50 60 70 80

0

-d(R

FU)/

dT

Melt peak

Temperature, Celsius

2nd CMTA point (cycle 40) 3rd CMTA point (cycle 50)

NG NG CT

(positives / tests)

* 10-plex real-time PCR (7 analytes + dual targets for CT & NG + IC) : Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, Ureaplasma parvum** Singleplex real-time PCR (1 analyte) : Chlamydia trachomatis

TOCE™ technology provides a level of sensitivity equivalent to probe-based singleplex real-time PCR.

C. trachomatisSerial dilution of ATCC strains 10-1

24 /24

24 /24

24 /24

24 /24

10-2

24 /24

24 /24

10-3

22 /24

20 /24

10-4

7/24

3/24

10-5

0/24

0/24

10-6

TOCE™ - based 10-plex real-time PCR *

Probe - based singleplex real-time PCR **

A novel real-time PCR to detect Chlamydia trachomatis in first-void urine or genital swabs, Journal of Medical Microbiology(2006), 55, 1667-1674

Quantitation of chlamydia trachomatis 16S rRNA using NASBA amplification and a bioluminescent microtiter plate assay. Combinatorial Chemistry & high Throughput screening, 2000, 3, 303-313

1. 3. 5.

2. 4.6.

Development of multiplex real-time quantitative PCR for simultaneous detection of Chlamydia trachomatis and Ureaplasma parvum. Clinical Biochemistry 45 (2012) 663-667

Quantitative detection of Mycoplasma genitalium from first-pass urine of men with urethritis and asymptomatic men by real-time PCR. Journal of clinical microbiology, Apr. 2002. p. 1451-1455

Detection and Quantitation of Mycoplasma genitalium in Male Patients with Urethritis. Clinical Infectious Disease, 2003;37:602-5

Quantitative detection of Ureaplasma parvum (biovar 1) and Ureaplasma urealyticum (biovar 2) in urine specimens from men with and without urethritis by real-time Polymerase chain reaction. Sexually Transmitted Disease, June, 2007, vol. 34. No. 6, p. 416-419

Reference

ENG

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ENG

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SD77

-EN

2004

02B-

01

• Detection and differentiation of 7 major STI causing pathogens 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 the Seegene Viewer

STI-7 DetectionAnyplex™Ⅱ

www.seegene.comTaewon Bldg. 91 Ogeum-ro, Songpa-gu, Seoul 05548, Republic of Korea / Tel : +82-2-2240-4000 / Fax : +82-2-2240-4040 / E-mail : info@seegene.com

MIDDLE EASTDubai, UAETel : +971-4-558-7110 E-mail : sgme@seegene.com

USACalifornia, USATel : +1-925-448-8172E-mail : usa@seegene.com

CANADAToronto, CanadaTel : +1-800-964-5680E-mail : canada@seegene.com

BRAZILBelo Horizonte, BrazilTel : +55-31-25153003E-mail : contato@seegenebrazil.com.br

MEXICOMéxico city, MéxicoTel : + 52 (55)-8848-9646E-mail : mexico@seegene.com

GERMANY Düsseldorf, GermanyTel : +49-211-9943-4260E-mail : sgg@seegene.com

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

Not Available for Sale in the United StatesOrdering Information

Product Package Volume Cat No.

50 rxns SD7700Y

100 rxns SD7700X

50 rxns SD7500Y

100 rxns SD7500X

Anyplex™Ⅱ CT/NG Real-time Detection 50 rxns SD7200Y

Anyplex™Ⅱ STI-7 Detection

Anyplex™Ⅱ STI-5 Detection