Global Rapid Diagnostic Leader SD

2 HIV-2 positive HIV-1 positive 1 drop of blood (Simple) Wait in 1~5 Min. (Fast) Interpret the result visually (Accurate) Rapid Test ? Everybody can detect all of HIV-1 and HIV-2 with only 1 drop of blood in Everywhere, Every time General Information

3 SD BIOLINE HIV-1/2 3.0 Test Immunochromatographic Test for the antibodies of all isotype (IgG, IgM, IgA) specific to HIV-1 including subtype O and HIV-2  The 3rd Generation Method (Direct Sandwich Method, Ag-Ab-Ag)  Serum/Plasma/Whole Blood specimens are avaiable  HIV-1 Subtype “O” Detectable  IgM Detectable : Early HIV1/2 detectable  Sensitivity : 100%  Specificity : 99.8%  Using Capture Antigen : HIV-1 (p24, gp41), HIV-2 (gp36)Ag  Approved by KFDA  Evaluated by WHO  Participation of WHO Tender

4 Quality Data Total numbers of PanelsSD HIV1/2 3.0 Rapid testAbbott Determine Rapid test seroconversion panels tested with SD and compared to Abbott Determine HIV1 Number of missed samples compared to the potential best test  Result : The HIV 1 sensitivity level of SD HIV1/2 Rapid test is superior to Abbott Determine HIV 1. Evaluation 1. Performed by Pasteur Institute France

5 Quality Data I.D Number ---U.S. FDA-Licensed Anti-HIV EIA Test result--- SD BIOLINE HIV1/2 3.0 Abbott HIV-1/2 S/co Gen.Sys HIV S/co Gen.Sys. HIV-1/2 S/co Org.Tek HIV S/co PRB Negative PRB Negative 0.3 (Negative) 0.1 (Negative) 0.1 (Negative) 0.4 (Negative) PRB Positive 1.7 (Positive) 0.1 (Negative) 0.2 (Negative) 0.4 (Negative) PRB Positive 16.6 (Positive) 1.6 (Positive) 1.8 (Positive) 1.8 (Positive) PRB Positive PRB Positive PRB Positive Evaluation 2. Performed by Pasteur Institute with HIV-1 Seroconversion Panel BBI(PRB959) -This evaluation shows the result that SD BIOLINE HIV1/2 3.0 Test can detect antibody for HIV type-1 earlier than some U.S. FDA-Licensed Anti-HIV EIA Kits

6 Quality Data Evaluation 3. Performed by National AIDS RESEARCH INSTITUE in India (1) Panels of sera tested : total 90 sera including 45 confirmed anti-HIV positive and 45 confirmed anti-HIV negative sera by INNO-LIA HIV confirmation(Innogenetics) (2) Evaluation Result - Sensitivity : 100% - Specificity : 100% Evaluation 4. Performed by Christian Medical College and Hospital in India (1) Panels of sera tested : total 100 sera including 25 confirmed anti-HIV positive and 75 confirmed anti-HIV negative sera by PCR (2) Evaluation Result - Sensitivity : 100% - Specificity : 100%

7 Quality Data Evaluation 5. Performed by National AIDS REFERENCE LABORATORY in Malaysia (1)Panels of sera tested : total 100 sera including 50 confirmed anti-HIV type-1 positive and 50 confirmed anti-HIV type-1 negative sera (2)Evaluation Result - Sensitivity : 100% - Specificity : 100%

8 Quality Data Asymptomatic(CDC II)ARC(CDC III)AIDS(CDC IV)Sensitivity SD BIOLINE HIV-1/2 rapid % Behring Anti-HIV1/2 ELISA % A. Evaluation Result with 30 sera of anti-HIV-1 positive Asymptomatic(CDC II)ARC(CDC III)AIDS(CDC IV) Sensitivity SD BIOLINE HIV-1/2 rapid % Behring Anti-HIV1/2 ELISA % PositiveNegativeSpecificity SD BIOLINE HIV-1/2 Rapid % Behring Anti-HIV1/2 ELISA % B. Evaluation Result with 25 sera of anti-HIV-2 positive C. Evaluation Result with 502 sera of anti-HIV-1/2 negative Evaluation 6. Internal evaluation with clinical sera  The result shows that the the accuracy of SD BIOLINE HIV 1/2 is equal to other commercial ELISA kits.

9 Quality Data Evaluation 7. WHO evaluation (phase1) of HIV1/2 Rapid test 1. Result Table Result Sensitivity 100% HIV-1 : 100% HIV-2 : 100% Specificity 99.3% Seroconversion panel : Similar result Behring ELISA SD HIV1/ Reference

10 Quality Data -This evaluation shows the result that SD BIOLINE HIV1/2 3.0 Test can detect antibody for HIV earlier than other commercial HIV1/2 Rapid test kits

11 Quality Data