sd bioline dengue rdt series...ns1 ag igg/igm sd bioline dengue duo (ns1 ag and igg/igm) 1 2 3...

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Dengue RDT Series SD BIOLINE Dengue Duo (NS1 Ag + Ab Combo) SD BIOLINE Dengue NS1 Ag SD BIOLINE Dengue IgG/IgM The most perfect diagnostic tool for dengue infection SD BIOLINE Dengue RDT Series

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Page 1: SD BIOLINE Dengue RDT Series...NS1 Ag IgG/IgM SD BIOLINE Dengue Duo (NS1 Ag and IgG/IgM) 1 2 3 Simple Testing Process Reading Results Dengue NS1 Ag Dengue IgG/IgM One step, immunochromatographic

Dengue RDT Series• SD BIOLINE Dengue Duo (NS1 Ag + Ab Combo)• SD BIOLINE Dengue NS1 Ag• SD BIOLINE Dengue IgG/IgM

The most perfect diagnostic tool for dengue infectionSD BIOLINE Dengue RDT Series

Page 2: SD BIOLINE Dengue RDT Series...NS1 Ag IgG/IgM SD BIOLINE Dengue Duo (NS1 Ag and IgG/IgM) 1 2 3 Simple Testing Process Reading Results Dengue NS1 Ag Dengue IgG/IgM One step, immunochromatographic

SD BIOLINE Dengue DuoSimultaneous detection of Dengue Ag & Ab

Why do we use SD Dengue Duo (NS1 Ag/Ab combined test) ?

Only use Dengue IgG/IgM Ab test Only use Dengue NS1 Ag test

The patient (with Dengue virus) had high fever last night.

The patient (with Dengue virus)had high fever from 1 week ago.

Go to the hospitalthis morning.

The patient just took an aspirin but,couldn’t get over.

Go to the hospitalthis morning.

Dr. said it is not Dengue feverBecause

Dr. tested only Dengue NS1 Ag test.

Dr. said it is not Dengue feverBecause

Dr. tested onlyDengue IgG/IgM Ab test.

NS1 Ag + Ab Combo

Detecting All Clinical stage

for acute phase samples (day 1~5)

NS1 Agfor convalescence phase samples (after day 3-5)

IgG/IgM

0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY 0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

0

NS1 Ag

IgM

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

Detecting all clinical stages

0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY 0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

0

NS1 Ag

IgM

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

Detecting all clinical stages

0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY 0

NS1 Ag

IgM

Not available

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

0

NS1 Ag

IgM

IgG

1 2 3 4 5 6 7 8 9>_

Ag

/Ab

leve

l

DAY

Detecting all clinical stages

Page 3: SD BIOLINE Dengue RDT Series...NS1 Ag IgG/IgM SD BIOLINE Dengue Duo (NS1 Ag and IgG/IgM) 1 2 3 Simple Testing Process Reading Results Dengue NS1 Ag Dengue IgG/IgM One step, immunochromatographic

SD BIOLINE Dengue Duo (NS1 Ag and IgG/IgM) NS1 Ag IgG/IgM

21 3

Simple Testing Process

Reading Results

Dengue NS1 Ag Dengue IgG/IgM

One step, immunochromatographic assay designed to detect both dengue virus NS1 antigen and antibodies IgG/IgM against dengue virus in human whole blood, serum or plasma.

Add 3 drops (about 100μl) of serum, plasma or whole blood into the sample well.

Read at 15~20 minutes

Add 10μl of serum, plasma or whole blood into the sample well.

Add 4 drops (about 90~120μl) of assay diluents into the assay diluents well round shaped.

NS1

NS1/IgM

IgG

IgG/IgM NS1

IgG/IgM

IgM

� The first in the world � The most perfect diagnostic tool to cover all clinical stage for acute phase

to convalescence phase. � Fast test result : 15~20 minutes � Convenient storage condition: 1~30 ºC

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

C

C2 1

T

S

CT

CMG

CT

CMG

CT

CMG

CT

CMG

CT

CMG

CT

CMG

CT

CT

CMG

CMG

CMG

CMG

Positive

Invalid

Negative

Dengue NS1 Ag(VS, RT-PCR)

Dengue IgG/IgM(VS, ELISA)

Sensitivity 92.4% 94.2%

Specificity 98.4% 96.4%

Page 4: SD BIOLINE Dengue RDT Series...NS1 Ag IgG/IgM SD BIOLINE Dengue Duo (NS1 Ag and IgG/IgM) 1 2 3 Simple Testing Process Reading Results Dengue NS1 Ag Dengue IgG/IgM One step, immunochromatographic

The most perfect diagnostic tool for dengue infection

SD BIOLINE Dengue NS1 Ag Rapid Test

SD BIOLINE Dengue IgG/IgM Rapid Test

Ordering Information

� Diagnosis of acute dengue infection to detect NS1 Ag � Detection of dengue NS1 Ag from day 1 after onset of fever (acute phase) � Fast test result : 15~20 min. � Specimen : Serum, Plasma or Whole blood � Storage temperature : 1 - 30 ºC � Sensitivity : 92.4%, Specificity : 98.4%

� Differential detection of IgG and IgM (Primary and secondary infection) � Detection of IgG and IgM antibodies dengue virus against of all serotype DEN-1, 2, 3 & 4. � No cross reactivity with other Flavivirus group and mosquitoes-borne disease like Malaria � Fast test result : 15~20 min. � Storage temperature : 1~30 ºC

Product Cat. No. Description Specimen Type Test Kit

Dengue Duo 11FK45Dengue NS1 Ag

and IgG/IgM Ab testWhole blood/

Serum/PlasmaDual-Device 10T

Dengue Duo 11FK46Dengue NS1 Ag

and IgG/IgM Ab testWhole blood/

Serum/PlasmaDual-Device 25T

Dengue NS1 Ag 11FK50 Dengue NS1 Ag testWhole blood/

Serum/PlasmaDevice 25T

Dengue IgG/IgM 11FK10Dengue

IgG/IgM Ab testSerum/Plasma Device 25T

Dengue IgG/IgM WB

11FK20Dengue

IgG/IgM Ab testWhole blood/

Serum/PlasmaDevice 25T

© 2013 Alere. All rights reserved. The Alere Logo and Alere are trademarks of the Alere group of companies.Cat. No. LEF11EN / Rev. 1309-00

Distributed by:

alere.com

STANDARD DIAGNOSTICS, INC.65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of KoreaTel : +82-31-899-2800 Fax : +82-31-899-2840 www.standardia.com Mail : [email protected]

Dengue IgG/IgM WB (11FK20)

Dengue IgG/IgM (11FK10)

Sensitivity 94.2% 94.6%

Specificity 96.4% 96.5%

SpecimenWhole blood / Serum /

PlasmaSerum / Plasma

SD BIOLINE Dengue RDT Series