1. Global Rapid Diagnostic Leader SD

2. 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. 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. 4 Quality Data Total numbers of PanelsSD HIV1/2 3.0 Rapid testAbbott Determine Rapid test 654244 65 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. 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 PRB95 9-01 Negative0.1 0.3 PRB95 9-02 Negative 0.3 (Negative) 0.1 (Negative) 0.1 (Negative) 0.4 (Negative) PRB95 9-03 Positive 1.7 (Positive) 0.1 (Negative) 0.2 (Negative) 0.4 (Negative) PRB95 9-04 Positive 16.6 (Positive) 1.6 (Positive) 1.8 (Positive) 1.8 (Positive) PRB95 9-05 Positive9.13.07.34.2 PRB95 9-06 Positive8.63.27.64.7 PRB95 9-07 Positive8.53.47.85.3 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. 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. 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. 8 Quality Data Asymptomatic(CDC II)ARC(CDC III)AIDS(CDC IV)Sensitivity SD BIOLINE HIV-1/2 rapid10146100% Behring Anti-HIV1/2 ELISA10146100% 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 2032100% Behring Anti-HIV1/2 ELISA 2032100% PositiveNegativeSpecificity SD BIOLINE HIV-1/2 Rapid150199.8% Behring Anti-HIV1/2 ELISA0502100% 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. 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 HIV1/2 +159 -294 Reference +- 1572 0294 157296

10. 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. 11 Quality Data