dengue duo

8/11/2019 Dengue Duo

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Dengue Duo Rapid TestDengue Ag NS1Dengue IgG/IgM

Dengue NS1 AgEarly DetectionDay 1 after onset of feve r

Dengue IgG/IgMLong lasting andStable Detection

SDDengue DuoSDDengue Duo

The NS1 antigen is expected to be detected 1 day after the onset offever and persist up to 9 days in both primary and secondary dengue

infection. But if anti-NS1 antibodies produced, the detection of NS1is inhibited. Primary dengue is characterized by the presence ofdetectable IgM 3~4 days after the onset of infection. Secondarydengue is characterized by the elevation of specific IgG 1~2 daysafter the onset of infection and in the majority of cases this is gener-ally accompanied by an elevation of IgM.

Advantage 1. Diagnose Dengue Ag NS1 even during window periodAdvantage 2 . Compensating weakness of antigen single test

Advantage 3. Easy to Use : Fast test result & Storage condition

To perfect diagnosis of dengue infection

during all clinical stages, Dengue antigen

and antibodies have to tested together.

A n t i b o

d y

& A

n t i g e n

l e v e

l

Detecting NS1 Ag

IgM

IgG

Detecting Antibodies

Dengue Duo : Detecting all stages

Primary Infection

NS1 Ag NS1 Ag

SecondaryInfection

Onset of symptoms Onset of symptoms

IgM

Detecting NS1 Ag

Detecting Antibodies



Complementary Ag&Ab Duo testDesigned to detect dengue virus NS1 antigen and IgG/IgM

Complementary Dengue NS1 Ag & IgG/IgM Ab Duo test

• 1st day after the onset of fever up to day 9(IgM : 3 - 4 day after the onset of fever)

• Circulating level : 0.01 to 50µg/ml(600ng/ml within 3 days of illnesss onset)

Profile of DV1 NS1 detection in blood circulation and IgM antibodyresponse to DV from the onset of symptoms to the convalescencephase (Hua Xu, et al, Journal of Clinical Microbiology, August 2006,Vol. 44, No. 8, p. 2872-2878)

※ Performance Clinical Evaluationsr at SD Biotech Institute and Yon-Sei University

Dengue NS1 antigen is a highly conservedglycoprotein that seems to be essential for virus viability,but has no established biological activity. Unusually for aviral glycoprotein, NS1 is produced in both membrane-associated and secreted forms. This NS1 antigen is pres-ent at high concentrations in the sera of dengue virus-infected patients during the early clinical phase of thedisease so it could be used as a suitable marker of denguevirus infection.

• Detection of infection prior to seroconversion• NS1 Ag can be detected in serum from Day 1 after onsetof fever and up to Day 9

• IgG/IgM antibodies are not detectable until Day 3-4

• Not detectable once anti-NS1 IgG antibodies areproduced• Differentiation between primary and secondary dengue

by differential detection of IgG/IgM

While existing dengue tests identify the virus indirectly by detecting antibodies, which are produced only three to

four days after the appearance of the first symptoms, the SD BIOLINE Dengue Duo test is able to detect thevirus from he first day of symptoms.

1

10

20

30

40

50

60

70

80

90

100 IgM antibodyDV1 NS1 protein

R a t e s o

f d e t e c t i o n

( % )

Days after onset of symptoms0 2 3 4 5 6 7 8 9 10 >2011-1516-20

To perfect diagnosis of dengue infection during allstages, Dengue antigen and antibodies have to testedtogether.Days after onset of fever

P o s

i t i v e R a t e

NS1 Ag

IgM

IgG

0%

20 %

40 %

60 %

80 %

100%

1~3 4~6 7~9 10~1 2 13 ~1 5 16~1 8

Perfect diagnosis of dengue infection during all stages

D ay

1~ 3

4~ 6

7~ 9

10~12

13~15

16~18

Ig M

21 %

48 %

100%

100%

100%

100%

IgG

4%

22 %

64 %

90 %

100%

95 %

N S1

88 %

83 %

64 %

20 %

46 %

5%

Final result

88 %

100%

100%

100%

100%

100%

Detecting NS1 Antigen Detecting Antibodies



※ Performance Clinical Evaluationsr at SD Biotech Institute and Yon-Sei University

Ag & AbDouble detection

Easy to UseRapid test

From the early stageto the late stege

Roomtemperature

Advantage 1. Diagnose Dengue Ag NS1 even during window period• The sensitivity of antibody test does not become acceptable until five days after the onset of fever.• NS1 antigen and IgM antibodies were detected concomitantly during the acute phase, but from day 1 to day 3, NS1 antigen

showed a more sensitive detection. According to the studies and to our results, the presence of NS1 in human sera canbe confirmed between days 0 and 9 (day 0 corresponding to the onset of fever), whereas IgM antibodies do not begin toappear until the early convalescence phase

• The use of NS1 detection as a first-line test for the diagnosis of acute dengue infection, using serum samples collectedduring the onset of clinical symptoms (day 0 to day 4), could help to accelerate the diagnosis of dengue fever in clinicaldiagnostic laboratories

Performance Clinical Evaluations1-1. Dengue NS1

2. Sensitivity of SD Dengue Duo

Advantage 2. Compensating weakness of antigen single test• The NS1 antigen could be detected until day 18 after the onset of symptoms• Physicians using this proposed acute and early convalescence diagnostic strategy on inpatients and outpa tients should

be able to obtain rapid, specific dengue diagnosis within a few hours for acute-phase samples, but such diagnoses shouldalso be possible for patients presenting at a late stage of the disease.

Advantage 3. Easy to Use : Fast test result & Storage condition• Much faster than ELISA test• Room Temperature storage condition

• Sensitivity : 92.8%• Specificity : 98.4%• Confirmed by RT-PCR and/or viral culture

• Sensitivity : 99.4%• Specificity : 93%• Reference assay : HI test

• Related to clinical signs apparition

SD BIOLINEDengue NS1 Ag

PositivePositive Negative

RT - PCR and/or Viral culture

NegativeTotal

1048

112

3186189

Total

107194301

1-2. Dengue IgG/IgM

SD BIOLINEDengue IgG/IgM

PositivePositive NegativeReference assay : HI test

NegativeTotal

1591

160

33942

Total

16240202

SD BIOLINEDengue IgG/IgM

PositivePositive NegativeReference assay : HI test

NegativeTotal

1591

160

33942

Total

16240202

Days after symptomonset

1 ~ 78 ~ 14Primary

Infection

SecondaryInfection

15 ~ 211 ~ 7

8 ~ 1415 ~ 21

No. ofsamples

No. of positive samples (%)

IgG Antibody5230

36363442

9 (17.3)26 (86.7)

35 (97.2)24 (66.7)34 (100)42 (100)

IgM Antibody21 (40.4)30 (100)

36 (100)8 (22.2)18 (53)

24 (57.2)

Total Antibody (*1)23 (44.2)30 (100)

36 (100)24 (66.7)34 (100)42 (100)

NS1 Ag43 (82.7)15 (50)

5 (13.9)24 (66.7)14 (41.2)3 (7.2)

Final Result (*2)49 (94.3)30 (100)

36 (100)32 (88.9)34 (100)42 (100)



Ordering InformationGroup

Rapid Test

ELISA

Product

Dengue IgG/IgM

Dengue Duo

Dengue IgG/IgM WB

Dengue Capture IgG ELISA

11FK45

11FK10

11FK20

11EK10

11EK20

Dengue NS1 antigenand IgG/IgM antibodies test

Dengue virus IgG and IgM test

Dengue virus IgG and IgM test

Anti-Dengue virus IgG test

Anti-Dengue virus IgM test

Serum / Plasma

Serum / Plasma

Serum / Plasma / Whole Blood

Serum

Serum

Device

Device

Device

Microplate

Microplate

10T

25T

25T

96T

96TDengue Capture IgM ELISA

Cat. No. Description Specimen Type Tests/Kit

Interpretation

156-68 Hagal-dong, Giheung-gu, Yongin-si, Gyeonggi-do, KoreaTel : +82-31-899-9700 Fax : +82-31-899-9740www.standardia.com E-mail : [email protected]

Test Procedure

Using disposable dropper provided, add 3 drops of serum orplasma into the sample well marked "S".

Using capillary pipette provided,add 5µl of serum or plasma intothe sample well marked "S".

Put 4 drops of assay diluent intothe assay diluent well round shaped.

Rev. SDC-0805

Interpret test results in15~20 minutes.

15~20 mins

4 drops

3 drops

[Dengue IgG / IgM]

[Dengue NS1 Ag]

PositiveNS1 Positive IgG Positive IgM Positive NS1 / IgM Positive IgG / IgM Positive

Negative

Perfect diagnosis of dengue infection during all stages

DENGUEIgG/IgM

DENGUENS1 Ag

DENGUEIgG/IgM

DENGUENS1 Ag

DENGUEIgG/IgM

DENGUENS1 Ag

DENGUEIgG/IgM

DENGUENS1 Ag

DENGUEIgG/IgM

DENGUENS1 Ag

DENGUEIgG/IgM

DENGUENS1 Ag

dengue duo

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