Rapid Diagnosis of Dengue virus

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Presentation transcript:

Rapid Diagnosis of Dengue virus STANDARD DIAGNOSTICS, INC. KOREA

SD Dengue IgG / IgM Test

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

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.

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

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

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

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%

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)

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.

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