1. Rapid Diagnosis of Dengue virus
STANDARD DIAGNOSTICS, INC. KOREA

2. SD Dengue IgG / IgM Test

3. Rec. Dengue Ag – gold conjugate Rec. Dengue Ag – gold conjugate
Design Process ;
Diagram of Dengue IgG/IgM Test Development
- Differential Detection by Double Sandwich System
Target materials : Dengue IgG and Dengue IgM
Recombinant antigen : high sensitive and specific
Rec. Dengue Ag – gold conjugate
Rec. Dengue Ag – gold conjugate
Dengue IgG in specimen
Dengue IgM in specimen
McAb anti-human IgM
McAb anti-human IgG
Test Line M
Test Line G

4. Interpretation of results
Final Product Characteristics ;
Test Method of SD Dengue IgG / IgM
Test Procedure
Interpretation of results
Negative
IgM Positive
IgG Positive
IgG/IgM Positive
G M C
Serum, Plasma, Whole Blood Sample
- Adding 1 L sample
- Adding 4 drops assay buffer
- Read the result in 10 ~ 30 min.

5. Comparison investigation vs. Competitor
[PanBio Dengue Duo Rapid Strip]

6. Comparison investigation vs. Competitor
[PanBio Dengue Duo Rapid Strip]
Dengue IgG ; Limit of Detection
SD Dengue IgG/IgM PanBio Dengue Duo
*Conclusion : SD x32-diluted detectable apparently
PanBio x 8-diluted detectable
Finally, SD superior to PanBio on IgG detection

7. Comparison investigation vs. Competitor
[PanBio Dengue Duo Rapid Strip]
Dengue IgM ; Limit of Detection
SD Dengue IgG/IgM PanBio Dengue Duo
*Conclusion : SD x16-diluted detectable apparently
PanBio x4-diluted detectable
Finally, SD superior to PanBio on IgM detection

8. Summary of Clinical Evaluation of
SD Dengue IgG/IgM Rapid Test in Yonsei Univ.
Investigator : Sang nae, Cho
College of Medicine, Yonsei University, Korea
Test Period : April, 2003
Positive Sample : 65 Positive clinical samples tested by Hemagglutination
Inhibition test (which samples oriented from RITM, Philippines)
Negative Sample : 200 normal healthy human serum
Comparison studies with competitor (PanBio Dengue Duo Rapid strip)
Conclusion
1) Accuracy vs. HI on positive rate
IgM ; SD = 98.5% PanBio = 98.5%
IgG ; SD = 72.3% PanBio = 64.6%
2) Specificity vs. HI
IgM ; SD = 98.5% PanBio = 99.5%
IgG ; SD = 100% PanBio = 99.0%

9. Summary of Clinical Evaluation of
SD Dengue IgG/IgM in SD Biotech Institute
Comparison of SD BIOLINE Dengue IgG / IgM Rapid Test with HI Test
Conclusion : SD BIOLINE Dengue IgG / IgM Rapid Test showed good correlation with hemagglutination-inhibition (HI) test
(*Patient samples oriented from RITM, Philippines)

10. Summary of Clinical Evaluation of
SD Dengue IgG/IgM in SD Biotech Institute
Sensitivity
To assess sensitivity, 15 paired specimen from patients with primary infection and 20 paired specimen with secondary infection were tested.
(*Patient samples oriented from RITM, Philippines)
Conclusion
SD BIOLINE Dengue IgG / IgM Rapid Test showed that it could diagnose the majority of dengue virus effectively.

11. Summary of Clinical Evaluation of SD Dengue IgG/IgM in NIH, Korea
Cross-reactivity test with other Flavivirus mediated and mosquitoes-borne disease
Conclusion
SD BIOLINE Dengue IgG / IgM Rapid Test showed no cross-reactivity with other Flavivirus mediated disease and mosquitoes-borne disease like Malaria