Dengue Duo Rapid Test

Dengue Ag NS1
Dengue IgG/IgM

Advantage 1. Diagnose Dengue Ag NS1 even during window period

Advantage 2. Compensating weakness of antigen single test
Advantage 3. Easy to Use : Fast test result & Storage condition

Dengue NS1 Ag
SD Dengue IgG/IgM
Early Detection Dengue Duo Long lasting and
Day 1 after onset of fever Stable Detection

Dengue Duo : Detecting all stages The NS1 antigen is expected to be detected 1 day after the onset of
fever and persist up to 9 days in both primary and secondary dengue
Detecting Antibodies Detecting Antibodies
infection. But if anti-NS1 antibodies produced, the detection of NS1
Detecting NS1 Ag Detecting NS1 Ag is inhibited. Primary dengue is characterized by the presence of
Primary Infection Secondary
detectable IgM 3~4 days after the onset of infection. Secondary
Infection dengue is characterized by the elevation of specific IgG 1~2 days
after the onset of infection and in the majority of cases this is gener-
IgG
Antibody & Antigen level

ally accompanied by an elevation of IgM.

NS1 Ag NS1 Ag
To perfect diagnosis of dengue infection
during all clinical stages, Dengue antigen
IgM IgM
and antibodies have to tested together.
Onset of symptoms Onset of symptoms
Perfect diagnosis of dengue infection during all stages

Complementary Ag&Ab Duo test

Designed to detect dengue virus NS1 antigen and IgG/IgM antibodies

Dengue NS1 antigen is a highly conserved 100 IgM antibody

glycoprotein that seems to be essential for virus viability, DV1 NS1 protein
90
but has no established biological activity. Unusually for a 80
viral glycoprotein, NS1 is produced in both membrane- 70
associated and secreted forms. This NS1 antigen is pres- 60

Rates of detection (%)

ent at high concentrations in the sera of dengue virus- 50
infected patients during the early clinical phase of the 40

disease so it could be used as a suitable marker of dengue 30

virus infection. 20

10
• 1st day after the onset of fever up to day 9
(IgM : 3 - 4 day after the onset of fever) 0 1 2 3 4 5 6 7 8 9
Days after onset of symptoms
10 11-15 16-20 >20

Profile of DV1 NS1 detection in blood circulation and IgM antibody

• Circulating level : 0.01 to 50µg/ml response to DV from the onset of symptoms to the convalescence
(600ng/ml within 3 days of illnesss onset) phase (Hua Xu, et al, Journal of Clinical Microbiology, August 2006,
Vol. 44, No. 8, p. 2872-2878)

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 the
virus from he first day of symptoms.

Complementary Dengue NS1 Ag & IgG/IgM Ab Duo test

D ay IgM IgG NS1 Final result

1~3 21% 4% 88% 88%

4~6 48% 22% 83% 100%

IgM
100% 7~9 100% 64% 64% 100%
IgG
10~12 100% 90% 20% 100%
80%
Positive Rate

13~15 100% 100% 46% 100%

60%
16~18 100% 95% 5% 100%

40% ※Performance Clinical Evaluationsr at SD Biotech Institute and Yon-Sei University

20%
NS1 Ag
To perfect diagnosis of dengue infection during all
0% stages, Dengue antigen and antibodies have to tested
1 ~3 4 ~6 7 ~9 1 0 ~1 2 1 3 ~1 5 1 6 ~1 8

Days after onset of fever together.

Detecting NS1 Antigen Detecting Antibodies

• Detection of infection prior to seroconversion • Not detectable once anti-NS1 IgG antibodies are
• NS1 Ag can be detected in serum from Day 1 after onset produced
of fever and up to Day 9 • Differentiation between primary and secondary dengue
• IgG/IgM antibodies are not detectable until Day 3-4 by differential detection of IgG/IgM
 Ag & Ab Easy to Use From the early stage Room
Double detection Rapid test to the late stege temperature

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 can
be confirmed between days 0 and 9 (day 0 corresponding to the onset of fever), whereas IgM antibodies do not begin to
appear 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 collected
during the onset of clinical symptoms (day 0 to day 4), could help to accelerate the diagnosis of dengue fever in clinical
diagnostic laboratories

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 should
also 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

Performance Clinical Evaluations

1-1. Dengue NS1 1-2. Dengue IgG/IgM
RT - PCR and/or Viral culture Reference assay : HI test
Total Total
Positive Negative Positive Negative
Positive 104 3 107 Positive 159 3 162
SD BIOLINE Negative 8 186 194 SD BIOLINE Negative 1 39 40
Dengue NS1 Ag Dengue IgG/IgM
Total 112 189 301 Total 160 42 202

• Sensitivity : 92.8% Reference assay : HI test

Total
Positive Negative
• Specificity : 98.4% Positive 159 3 162
• Confirmed by RT-PCR and/or viral culture SD BIOLINE Negative 1 39 40
Dengue IgG/IgM
Total 160 42 202

• Sensitivity : 99.4%
• Specificity : 93%
2. Sensitivity of SD Dengue Duo • Reference assay : HI test
• Related to clinical signs apparition
Days after symptom No. of No. of positive samples (%)
onset samples IgG Antibody IgM Antibody Total Antibody (*1) NS1 Ag Final Result (*2)
1~7 52 9 (17.3) 21 (40.4) 23 (44.2) 43 (82.7) 49 (94.3)
Primary 8 ~ 14 30 26 (86.7) 30 (100) 30 (100) 15 (50) 30 (100)
Infection 15 ~ 21 36 35 (97.2) 36 (100) 36 (100) 5 (13.9) 36 (100)
1~7 36 24 (66.7) 8 (22.2) 24 (66.7) 24 (66.7) 32 (88.9)
Secondary 8 ~ 14 34 34 (100) 18 (53) 34 (100) 14 (41.2) 34 (100)
Infection 15 ~ 21 42 42 (100) 24 (57.2) 42 (100) 3 (7.2) 42 (100)
※Performance Clinical Evaluationsr at SD Biotech Institute and Yon-Sei University
Perfect diagnosis of dengue infection during all stages

Test Procedure
[Dengue NS1 Ag]

Interpret test results in

15~20 minutes.
3 drops

Using disposable dropper provided, add 3 drops of serum or 15~20 mins

plasma into the sample well marked "S".

[Dengue IgG / IgM]

4 drops

Using capillary pipette provided, Put 4 drops of assay diluent into

add 5µl of serum or plasma into the assay diluent well round shaped.
the sample well marked "S".

Interpretation
Positive Negative
NS1 Positive IgG Positive IgM Positive NS1 / IgM Positive IgG / IgM Positive

DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE DENGUE
NS1 Ag IgG/IgM NS1 Ag IgG/IgM NS1 Ag IgG/IgM NS1 Ag IgG/IgM NS1 Ag IgG/IgM NS1 Ag IgG/IgM

Ordering Information
Group Product Cat. No. Description Specimen Type Tests/Kit
Dengue NS1 antigen
Dengue Duo 11FK45 Serum / Plasma Device 10T
and IgG/IgM antibodies test
Rapid Test
Dengue IgG/IgM 11FK10 Dengue virus IgG and IgM test Serum / Plasma Device 25T

Dengue IgG/IgM WB 11FK20 Dengue virus IgG and IgM test Serum / Plasma / Whole Blood Device 25T

Dengue Capture IgG ELISA 11EK10 Anti-Dengue virus IgG test Serum Microplate 96T
ELISA
Dengue Capture IgM ELISA 11EK20 Anti-Dengue virus IgM test Serum Microplate 96T

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