Rapid Diagnosis of Dengue virus STANDARD DIAGNOSTICS INC

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

SD Dengue Ig. G / Ig. M Test STANDARD DIAGNOSTICS, INC.

Design Process ; Diagram of Dengue Ig. G/Ig. M Test Development - Differential Detection by Double Sandwich System - Target materials : Dengue Ig. G and Dengue Ig. M - Recombinant antigen : high sensitive and specific Rec. Dengue Ag – gold conjugate Dengue Ig. M in specimen Mc. Ab anti-human Ig. M Test Line M Dengue Ig. G in specimen Mc. Ab anti-human Ig. G Test Line G STANDARD DIAGNOSTICS, INC.

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

Comparison investigation vs. Competitor [Pan. Bio Dengue Duo Rapid Strip] STANDARD DIAGNOSTICS, INC.

Comparison investigation vs. Competitor [Pan. Bio Dengue Duo Rapid Strip] Dengue Ig. G ; Limit of Detection SD Dengue Ig. G/Ig. M Pan. Bio Dengue Duo *Conclusion : SD x 32 -diluted detectable apparently Pan. Bio x 8 -diluted detectable Finally, SD superior to Pan. Bio on Ig. G detection STANDARD DIAGNOSTICS, INC.

Comparison investigation vs. Competitor [Pan. Bio Dengue Duo Rapid Strip] Dengue Ig. M ; Limit of Detection SD Dengue Ig. G/Ig. M Pan. Bio Dengue Duo *Conclusion : SD x 16 -diluted detectable apparently Pan. Bio x 4 -diluted detectable Finally, SD superior to Pan. Bio on Ig. M detection STANDARD DIAGNOSTICS, INC.

Summary of Clinical Evaluation of SD Dengue Ig. G/Ig. M Rapid Test in Yonsei Univ. q Investigator : Sang nae, Cho College of Medicine, Yonsei University, Korea q Test Period : April, 2003 q Positive Sample : 65 Positive clinical samples tested by Hemagglutination Inhibition test (which samples oriented from RITM, Philippines) q Negative Sample : 200 normal healthy human serum q Comparison studies with competitor (Pan. Bio Dengue Duo Rapid strip) q Conclusion 1) Accuracy vs. HI on positive rate Ig. M ; SD = 98. 5% Pan. Bio = 98. 5% Ig. G ; SD = 72. 3% Pan. Bio = 64. 6% 2) Specificity vs. HI Ig. M ; SD = 98. 5% Pan. Bio = 99. 5% Ig. G ; SD = 100% Pan. Bio = 99. 0% STANDARD DIAGNOSTICS, INC.

Summary of Clinical Evaluation of SD Dengue Ig. G/Ig. M in SD Biotech Institute q Comparison of SD BIOLINE Dengue Ig. G / Ig. M Rapid Test with HI Test (*Patient samples oriented from RITM, Philippines) q Conclusion : SD BIOLINE Dengue Ig. G / Ig. M Rapid Test showed good correlation with hemagglutination-inhibition (HI) test STANDARD DIAGNOSTICS, INC.

Summary of Clinical Evaluation of SD Dengue Ig. G/Ig. M in SD Biotech Institute q 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) q Conclusion SD BIOLINE Dengue Ig. G / Ig. M Rapid Test showed that it could diagnose the majority of dengue virus effectively. STANDARD DIAGNOSTICS, INC.

Summary of Clinical Evaluation of SD Dengue Ig. G/Ig. M in NIH, Korea q Cross-reactivity test with other Flavivirus mediated and mosquitoesborne disease q Conclusion SD BIOLINE Dengue Ig. G / Ig. M Rapid Test showed no cross-reactivity with other Flavivirus mediated disease and mosquitoes-borne disease like Malaria STANDARD DIAGNOSTICS, INC.