Key features

Full range of causative pathogens (25 pathogens) in gastrointestinal tract infection

Short TAT (4 hours) from extraction to the �nal results

Informative data with individual Ct values for each analyte

Automated data interpretation with Seegene Viewer

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Allplex™

- Norovirus G I - Norovirus G II - Rotavirus - Adenovirus- Astrovirus - Sapovirus - Internal Control (IC)

- Campylobacter spp. - Clostridium di�cile toxin B - Salmonella spp. - Shigella spp. / EIEC* - Vibrio spp. - Yersinia enterocolitica - Aeromonas spp. - Internal Control (IC)

- Clostridium di�cile hypervirulent - E. coli O157- STEC* (stx1/2)- EPEC* (eaeA)- ETEC* (It/st) - EAEC* (aggR)- Internal Control (IC)

- Giardia lamblia - Entamoeba histolytica - Cryptosporidium spp. - Blastocystis hominis - Dientamoeba fragilis - Cyclospora cayetanensis - Internal Control (IC)

Analytes

Virus

Panel 1

Bacteria ( )

Panel 2

Bacteria ( )

Panel 3

Parasite

Panel 4

* EIEC: Enteroinvasive E. coli, STEC: Shiga toxin-producing E. coli, Enterohemorrhagic E. coli, EPEC: Enteropathogenic E. coli, ETEC: Enterotoxigenic E. coli, EAEC: Enteroaggregative E. coli

- StoolSpecimen

Gastrointestinal Panel AssaysComprehensive assay for the detection and identification of25 gastrointestinal pathogens using One-step Real-time RT-PCR

1 tube / 1 panel

Diarrhea can be caused by a wide range of bacterial, viral, and/or parasitic pathogens. Diagnosis based on conventional method has many problematic issues including high variation, low sensitivity, intensive labor and long turn around time. Recently, the multiplex real-time PCR based diagnosis has been highlighted because of many advantages including simultaneous detection of broad coverage of gastrointestinal tract infection(GI) pathogens, short turn around time and high reproducibility rate combined with automatic platforms.

Allplex™ Gastrointestinal Panel Assays is a multiplex One-step Real-time RT-PCR Assay that detects and identi�es 25 GI pathogens including 6 viruses, 13 bacteria and 6 parasites simultaneously. Based on Seegene’s proprietary MuDT™ technology, this assay reports multiple Ct values of each pathogen in a single channel using real-time PCR instruments.

Compatible instrumentation

Auto Extraction & PCR SetupSeegene NIMBUS IVD Seegene STARlet IVD (Hamilton)

Auto ExtractionNucliSENS® easyMAG® (BioMérieux)

Real-time PCRCFX96 DX

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REALTIMEP C R M a r k e d

Seegene’s powerful automation platform for complete test process

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User-friendly automation systemAutomatic data interpretation software optimized for multiplex assays Interlocked with LISMulti-Ct values in a single channel

Comparison of test procedure with existing products

The result represents the co-infection of B. hominis(BH) G. lamblia(GL) in FAM channel with Ct values of 20.10 (Graph 1) and 31.10 (Graph 2), respectively.

Result of Allplex™ Gastrointestinal Panel Assays

Graph 1 Graph 2Channel

FAM

Cal Red 610

Quasar 670

HEX

FAM

Cal Red 610

Quasar 670

HEX

1500

1000

500

0

0 10 20 30 40

RFU

Cycles

BH

Ct 20.10

1500

1000

500

0

0 10 20 30 40

RFU

Cycles

GL

Ct 31.10

1500

1000

500

0

0 10 20 30 40

RFU

Cycles

IC

Ct 33.16

1500

1000

500

0

0 10 20 30 40

RFU

Cycles

Product L

Product S

Seegene Allplex™ GI Assay

for 46 samples Ampli�cation & DetectonNucleic acid puri�cation

1hr 2hrs 3hrs 4hrs 5hrs 6hrs 7hrs 8hrs

Pre-treatment

1hr 2hrs 4hrs

2hrs 2hrs 4hrs

5 minutes

1.5hrs 2.5hrs

7hrs

8 hrs

4 hrs

What we don’t know...

Why we don’t know...

Re-tested results of Noro(-) samples (N=200) 3)

The relevant organisms are likely to be missed with current diagnostic cascades.4)

3) Clinical evaluation of Allplex™ GI Assay (Oral presentation at 2016 ECCMID, Seegene integrated symposium)4) MiQ 9 Infektionen des Darmes. Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik

795 stool samples tested in Australia, 9 cases of salmonellosis, and 24 cases of campylobac-teriosis were identified, when Salmonella and Listeria were tested only.2)

1) Gamarra RM et al. (updated 2015) https://emedicine.medscape.com/article/175569 2) Hellard M. et al. (2001) Environ Health Perspect. 109:774-784Detected Not detected

68% 3200 Deaths

1500 Deaths32%

Unknown

The majority of gastrointestinal infectious cases did not have a known pathogen identi�ed.1) 2)

We don’t know yet!

96%

334%

Unknown762 Cases

Gastrointestinal infections (food poisoning) caused by Salmonella and Listeria cause 1500 deaths annually in US. In fact, 3200 deaths are attributed by unidentified pathogens.1)

21

52

26

50

40

30

20

10

Allplex™GI-V

Allplex™GI-B(I)

Allplex™GI-B(II)

Allplex™GI-P

11%

26 %

13 %

19 %

38

No.

Stool condition

A

A.

BB.

114

6

32

2 1 1

Co-infections

27

3

Double infection

Triple infectionV + V

V + B

V + P

B + B

B + P

P + P

Double infections : 27 cases

Single infections : 69 cases

E.coil?

E.coil?

C.di�cile?

Infant?

Travel history?

Immunosuppression?

Bloody?

V + B + P B + B + P

Triple infections : 3 cases

Total number of positive results : 99 cases

Protozoa?

Vibro?

Aeromonas?

Vibro?

Protozoa?

E.coil?

Norovirus?

Salmonella?

Salmonella?

Watery?Infant?

Travel history?

Antibiotics / Surgery?

E.coil?

E.colil?

C.di�cile?

Rotavirus?

Protozoa?

Norovirus?

Results of additional pathogens detected by each panel

Cost DOWN !! Productivity UP !!

5) Post of instantlabs website, December 3rd, 2013 by Lauren Bambusch6) Oral presentation at 2016 ECCMID, Seegene integrated symposium

for 24 samples

Culture vs Allplex™ for bacteria6)

Costs for Reagent/Mediaconsumption

Costs for labor Sensitivity

%

75

50

25

100 %

1. 6 %

100 %

15 %

67%

94%120 hrs

72

48

24

120 hrs

4 hrsTAT

Cost Labor

Sensitivity

Time to Result 6)

98.4%reduced

85%reduced

30%Increased

Culture Allplex™Microscopy

Microscopy vs Allplex™ for parasites5)

TAT

Loadable sample numberper a staff in a day

Sample

240

160

80

25

288

Time to Result

hr

60

40

20

83 hrs

10 hrs

88%reduced

for 200 samples per a staff

Productivity91%Increased

A customer in Germany

We call current diagnostic process as the ‘Diagnostic cascade’. This term simply explains the current situation that some of relevant

organisms are indeed being excluded during diagnostic process.

A customer in Canada

Great performance with high clinical sensitivity and speci�city!

And, 63-fold of reductions in lab costs and expenses come with it.

The only solution is ‘Seegene’s Allplex™ GI Full panel Assays’ ”“ ” ”

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