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Global Rapid Diagnostic Leader SD

Global Rapid Diagnostic Leader SD. Company Introduction. Product Line. Products List. Rapid Tests. Hepatitis B, C HBsAg, Anti-HBs, HCV HBeAg/HBsAg Infectious Disease

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Global Rapid Diagnostic Leader SD

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  1. Global Rapid Diagnostic Leader SD

  2. Company Introduction

  3. Product Line

  4. Products List Rapid Tests • Hepatitis B, C HBsAg, Anti-HBs, HCV HBeAg/HBsAg • Infectious Disease • HIV-1/2, Syphilis, TB, Malaria, H.pylori, Chlamydia Ag, Dengue IgG/IgM, Leprosy, Salmonella typhi, Rotavirus, Tetanus, Influenza/H5, RSV, Rubella IgG/IgM • Tumor Marker • AFP, CEA, PSA, CEA/AFP, FOB • Drug of Abuse • MOP, MET, AMP, COC, THC, MET/THC, MDMA (ecstasy) • Fertility Hormone • hCG, LH, FSH • Veterinary Tests • Heartworm, Distemper, Parvo virus, FMD Urine Strip & reader • Urocolor (1~11para) • Urometer 600

  5. NewProducts Development Present (In 2006) • New Rapid Test • New Patent Device Fromat • Rubella IgG/IgM, Torch, Rota/Adeno, • Strep A, S. pnemoniae Expanding Into NEW business fields Long term (In 2008~ ) • Blood Glucose Meter • DNA Chip • Infectious Disease DNA Chip • Congenital Disease DNA Chip • Tumor DNA Chip Short term (In 2006~2007) • Protein Chip • Concept of Lab on a Chip • Infectious Disease Panel • : HIV1/2, Syphilis, HBV, TB, Malaria, HCV • Tumor Markers Panel • : AFP, CEA, PSA, CA19, CA125, CA15 • Allergy Panel: Food Allergy, Pollen Allergy

  6. 1 2 C HIV1/2 Competitiveness of Technology

  7. Int’l Quality Approval “Products Evaluation, Registration and Approval ”

  8. Sales Network “ 125 distributors in 75 Countries ” “ 12 Domestic distributors” Sales Network in Overseas Markets Domestic Sales Network KangNung Seoul SuWon WonJu ChungJu DaeJeon DaeGu JeunJu Busan Changwon GwangJu Jeju Asia 18 countries Middle East 12 countries Europe 17 countries America/ Africa 28 countries Domestic market China, Japan, Taiwan Thailand, India, Nepal Vietnam, the Philippines Bangladesh, Sri Lanka Myanmar, Pakistan Indonesia, Malaysia Hong Kong, Mongol Australia.Singapore, … Iran, Syria, Yemen Jordan, Israel, Lebanon. Palestine Saudi Arabia,Qatar Egypt. U.A.E.Oman, Germany, Swiss, Italy Romania, Poland, Turkey, Finland, UK, Lithuania, Russia, Croatia, France, Bulgaria,Denmark, Netherlands USA, Canada ,Mexico, , Panama, Bahamas,Guyana Brazil, Colombia, Guatemala Peru, Venezuela,Paraguay, Honduras,Ecuador….. Cameron, Sudan, Nigeria Mozambique, South Africa Uganda, Kenya, Tanzania Ghana, Benin, Burkina Faso Malawi, Zimbabwe… 12 Distributors by Region

  9. Influenza virus • General • History • Diagnostic Tools • AIV _ Human Infection

  10. Structure of Influenza virus Influenza Virus HA Antigen : Help virus absorption into cells NA Antigen : help virus segregation from cells

  11. H1 N1 H2 N2 H3 N3 Acute respiratory illness caused by Influenza viruses A subtype or B subtype H4 N4 H5 N5 H6 N6 N7 H7 • Major : A (H, N) • Human Infection • H1N1 • H3N2 • H2N2 • H5N1 N8 H8 N9 H9 H10 H11 H12 H13 H14 H15 (Karl G Nicholson, et al Lancet 2003; 362: 1733-45)

  12. Influenza Outbreak in 20th centuries 1918: “Spanish Flu” 1957: “Asian Flu” 1968: “Hong Kong Flu” 2003~4: “AIV H5” H5N1 H3N2 H2N2 H1N1 H1N1

  13. Major Influenza Pandemics Period

  14. “Spanish Flu” Pandemic (1918-1919) World-wide population 2 bil. (100 %) Infected polulation 0.4 bil. (20 %) Deaths 20-40 mil. (1-2 %) *Outbreak in healthy young people, in the majority of cases

  15. ‘Asian / HongKong Flu’ Pandemic (1957, 1968) Killed an estimated more than 1 mil. *Outbreak in old people, or patients with chronic disease, in the majority of cases

  16. Outbreak of HongKong A/H5N1 (1997) • Infection – 18 • Death- 6 • Protective slaughter on 1.5 mil. Chicken • No infection between human

  17. Outbreak of Vietnam A/H5N1 (2003~5) • Infection – 93 • Death- 42

  18. The Latest New Subtype Infection • 1999 ; HongKong, GhuangDong _ A/H9N2 • HongKong ; 2 persons infection • GhuangDong5 persons infection • 2003 ; HongKong _ A/H5N1 • 2 persons (family) infection, 2 persons death • Travel experience to Fujian • 2003 ; Netherland _ A/H7N7 • Infection from human to human • 2003 : HongKong _ A/H9N2 • 1 person infection

  19. Number of cases / Influenza H5/N1

  20. AIV_ human Infection Mechanism (1) Migratory birds poultry

  21. AIV_ human Infection Mechanism (2) Migratory birds poultry

  22. AIV_ human Infection Mechanism (3) Migratory birds poultry

  23. Influenza Diagnostic Table Procedure Influenza Types Detected Acceptable Specimens Time for Results Rapid result available Viral culture A and B NP swab, throat swab, nasal wash, bronchial wash, nasal aspirate, sputum 5-10days No ImmunofluorescenceDFA Antibody Staining A and B NP swab, nasal wash, bronchial wash, nasal aspirate, sputum 2-4 hours No RT-PCR A and B NP swab, throat swab, nasal wash, bronchial wash, nasal aspirate, sputum 1-2 days No Serology A and B paired acute and convalescent serum samples >2 weeks No Enzyme Immuno Assay(EIA) A and B NP swab, throat swab, nasal wash, bronchial wash 2 hours No Rapid Diagnostic Tests

  24. <Step 1> Surveillance on Central Hospital around region of outbreak of AIV Review & Collection of hospitalized records Collection of blood or respiratory specimen from possible case or not-caused ARDS Laboratory diagnosis at CDC, Dept. Of infectious disease control Poultry AIV – human infection Surveillance of Epidemiology case study by Korea CDC

  25. <Step 2> If, detection of AIV_human infection possible case, you should work on enlarged surveillance with all general hospital adjacent to the region of outbreak of AIV. Poultry AIV – human infection Surveillance of Epidemiology case study by Korea CDC

  26. Virus isolation in tissue culture cells, or virus inoculation into egg Viral nucleic acid : RT-PCR Hemagglutination Inhibition test (HI) Neutralization (NT) Infectious virus ELISA: recombinant antigen Western blot recombinant antigen Diagnosis of AIV infection to Human

  27. Diagnosis of AIV infection to Human Sample collection

  28. Diagnosis Flow chart Specimen collection Respiratory specimen Serum First, by Rapid Antigen Testing HI Participates in WHO/CDC programs for flu surveillance RT-PCR / Virus culture NT

  29. Possible Case Acute Respiratory Disease Syndrome, 38℃ high fever (and) cough (and/or) nasopharyngeal pain, Contact with A(H5N1) confirmed case during infection, or Visit at AIV outbreak poultry farm within 1 week before onset, or Person working at laboratory on research with AIV specimen Diagnosis of AIV infection to Human Diagnostic criteria (WHO, Vietnam 2004. 1.24)

  30. Probable Case Laboratory diagnostic test results on AIV human infection _ Positive (FA +H5 mcAb analysis) Or, no cause of other respiratory disease onset Confirmed Case A(H5N1) virus isolation H5 _ PCR positive H5 _ specific antibody titer x 4  in paired acute and convalescent serum samples Diagnosis of AIV infection to Human Diagnostic criteria (WHO, Vietnam 2004. 1.24)

  31. RAT (Rapid Antigen Test) SD BIOLINE Influenza Antigen (type A & B)SD BIOLINE Influenza H5 (A/H5N1)

  32. SD BIOLINE Influenza Antigen Kit SD BIOLINE Influenza Antigen rapid test is a chromatographic immunoassay for the differential and qualitative detection of influenza virus type A and type B antigens directly from nasal swab specimens, throat swab specimens, nasal/nasopharyngeal aspiratespecimens.

  33. Test Principle & Major active ingredient - Detection by Direct Sandwich System mouse monoclonal anti-influenza A/B-gold conjugate Gold Gold Gold Flu A Ag Flu B Ag in specimen in specimen mouse monoclonal anti-influenza B mouse monoclonal anti-influenza A C line B line(Influenza B type) A line(Influenza A type) • Target materials : Influenza antigen (type Aband B) • in respiratory specimen

  34. Test Results Appearance Negative Influenza type A Influenza type B positive positive

  35. Test procedure & Interpretation • Transfer assay diluent into test tube (approximately 300uL). • Insert the patient swab sample into the test tube and mix well. • Place the Test Strip into the test tube. • Read result at 10 ~ 15 minutes.

  36. Sample collection & Test procedure 2. Diluent 300 uL 1. Nasal swab

  37. SD BIOLINE Influenza Antigen Kit Sample collection & Test procedure 4. Discard the swab. 3. Extraction

  38. SD BIOLINE Influenza Antigen Kit Sample collection & Test procedure 6. Migration 5. Insert test strip into tube.

  39. Interpretation of Test Results A/H1N1 A/H3N2 B 3+ 2+ 1+ 3+ 2+ 1+ 3+ 2+ 1+ Neg.

  40. Comparison Table (Influenza RAT) Q SD BD

  41. Sensitivity per the virus type of strains

  42. Sensitivity per the virus type of strains

  43. Comparison data vs. RAT competitor Detection Limit of each virus type

  44. Clinical Evaluation Studies The performance of the SD BIOLINE Influenza antigen test was compared to cell culture or RT-PCR methods in a multi-center field clinical study. In this multi-center, a combination of nasal swabs and throat swabs specimens were collected from total 341 patients. *Test Period ; Oct.2003 ~ May 2005 *Test Region ; Korea & Overseas Vietnam (H5) HongKong Thailand, etc

  45. Clinical Evaluation Studies Summary of Clinical Evaluation Data

  46. Clinical evaluation studies results performed at National Institute of Hygiene and Epidemiology, Vietnam (including H5 Human cases) *Test period : Dec.2004 ~ Dec.2005

  47. Competitiveness of SD BIOLINE Influenza Antigen test Why should you use “SD BIOLINE Influenza Antigen Rapid Test”? SD kit can cover all influenza virus type. SD kit can detect AIV infection in Human (A/H5N1). SD kit can differentiate influenza virus type A and B SD kit is very useful as POCT (point of care testing), on-site test.

  48. SD BIOLINE Influenza H5 kit SD BIOLINE Influenza H5 rapid test is a chromatographic immunoassay for the qualitative detection of hemagglutinin H5 antigen of avian influenza (AI)virus directly from nasal swab/aspirate specimens, throat swab specimens, tracheal aspirate specimens on AI virus human infection cases.

  49. Test Principle & Major active ingredient - Detection by Direct Sandwich System mouse monoclonal anti-influenza H5-gold conjugate Gold Gold Flu H5 Ag in specimen mouse monoclonal anti-influenza H5 C line T line (Influenza A/H5) • Target materials : Hemagglutinin H5 antigen • of avian influenza (AI) virus in respiratory specimen

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