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Global Rapid Diagnostic Leader SD

Detect HIV-1 & HIV-2 with 1 drop of blood anywhere, anytime. Immunochromatographic test with high sensitivity and specificity. Approved by KFDA, evaluated by WHO. Performances data, accuracy comparison with other tests. 8

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Global Rapid Diagnostic Leader SD

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  1. Global Rapid Diagnostic Leader SD

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

  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 Evaluation 1. Performed by Pasteur Institute France • 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.

  5. 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 PRB959-01 Negative 0.1 0.1 0.1 0.3 PRB959-02 Negative 0.3 (Negative) 0.1 (Negative) 0.1 (Negative) 0.4 (Negative) PRB959-03 Positive 1.7 (Positive) 0.1 (Negative) 0.2 (Negative) 0.4 (Negative) PRB959-04 Positive 16.6 (Positive) 1.6 (Positive) 1.8 (Positive) 1.8 (Positive) PRB959-05 Positive 9.1 3.0 7.3 4.2 PRB959-06 Positive 8.6 3.2 7.6 4.7 PRB959-07 Positive 8.5 3.4 7.8 5.3 Quality Data 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 • Panels of sera tested : total 100 sera including 50 confirmed anti-HIV type-1 positive and 50 confirmed anti-HIV type-1 negative sera • Evaluation Result • - Sensitivity : 100% • - Specificity : 100%

  8. Quality Data Evaluation 6. Internal evaluation with clinical sera A. Evaluation Result with 30 sera of anti-HIV-1 positive B. Evaluation Result with 25 sera of anti-HIV-2 positive C. Evaluation Result with 502 sera of anti-HIV-1/2 negative • 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

  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

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