1. Global Rapid Diagnostic Leader SD

2. Company Introduction

3. Product Line

4. Products List Rapid Tests Urine Strip & reader 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. New Products 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. Competitiveness of Technology
Market leader
World-first developed products
HIV ½ antibody One Step Test (three lines)
2001
SARS Anti-Coronavirus Test
2003
AIV Ag Test (including H5) for veterinary use
2004
Influenza H5 Rapid test for human use
2005
HIV1/2
1 2 C

7. Int’l Quality Approval
“Products Evaluation, Registration and Approval ”
Item
WHO Evaluation
CE Mark
USA FDA
HIV1/2
Completed
Under process -
HCV
Syphilis
HBsAg
Malaria
hCG
H.pylori
Dengue
Influenza
Rota
Urine TB

8. Sales Network “ 125 distributors in 75 Countries ”
“ 12 Domestic distributors”
Sales Network in Overseas Markets
Domestic Sales Network
Seoul
KangNung
SuWon
WonJu
ChungJu
DaeJeon
DaeGu
JeunJu
Busan
GwangJu
Changwon
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
HA Antigen : Help virus absorption into cells
NA Antigen : help virus segregation from cells

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

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

14. Major Influenza Pandemics Period

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

16. ‘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

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

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

19. The Latest New Subtype Infection
1999 ; HongKong, GhuangDong _ A/H9N2
HongKong ; 2 persons infection
GhuangDong 5 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

20. Number of cases / Influenza H5/N1

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

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

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

24. 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
5-10 days No
Immunofluorescence DFA Antibody Staining
NP swab, nasal wash, bronchial wash, nasal aspirate, sputum
2-4 hours
RT-PCR
NP swab , throat swab, nasal wash, bronchial wash, nasal aspirate, sputum
1-2 days
Serology
paired acute and convalescent serum samples
>2 weeks
Enzyme Immuno Assay (EIA)
NP swab , throat swab, nasal wash, bronchial wash
2 hours
Rapid
Diagnostic Tests

25. Poultry AIV – human infection Surveillance of Epidemiology case study by Korea CDC
<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

26. Poultry AIV – human infection Surveillance of Epidemiology case study by Korea CDC
<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.

27. Diagnosis of AIV infection to Human
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

28. Diagnosis of AIV infection to Human
Sample collection
Description
Specimen
Collection time
Virus isolation
Respiratory specimen
Early stage of onset
Nucleic acid
RAT (rapid antigen test)
Serological
Serum
acute : Early stage of onset
covalescent : after 3 weeks

29. First, by Rapid Antigen Testing
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

30. Diagnostic criteria (WHO, Vietnam 2004. 1.24)
Diagnosis of AIV infection
to Human
Diagnostic criteria (WHO, Vietnam )
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

31. Diagnostic criteria (WHO, Vietnam 2004. 1.24)
Diagnosis of AIV infection
to Human
Diagnostic criteria (WHO, Vietnam )
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

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

33. 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
aspirate specimens.

34. mouse monoclonal anti-influenza A/B-gold conjugate
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

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

36. 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.

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

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

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

40. Interpretation of Test Results
A/H1N A/H3N B
Neg.

41. Comparison Table (Influenza RAT)
Q SD BD

42. Sensitivity per the virus type of strains
Virus types (strains)
Detection
Sensitivity
Influenza virus,TypeA(H1N1) HN2242 (cultured sample) ○
0.5HAU
Influenza virus,TypeA(H1N1) HN2253 (cultured sample)
0.25HAU
Influenza virus,TypeA(H1N1) HN2475 (cultured sample)
0.125HAU
Influenza virus, TypeA(H1N1)Taiwan/1/86 81N73
Influenza virus, TypeA(H1N1)Beijing/262/95 81N73-2
Influenza virus, TypeA(H1N1)/WS/33 VR1520(27HAU) (cultured sample)
Influenza virus,TypeA(H3N2) HN30109 (cultured sample)
Influenza virus,TypeA(H3N2) HN30135 (cultured sample)
0.0625HAU
Influenza virus,TypeA(H3N2) HN30240 (cultured sample)
Influenza virus, TypeA(H3N2)/Hongkong/8/68 VR544(26HAU) (cultured sample)
Influenza virus, TypeA(H3N2)/Shangdong/9/93 81N74
Influenza virus, TypeA(H3N2)/Panama/2007/99 81N74-1
Influenza virus, TypeA(H3N2)Kiev/301/94 like/Johannesburg/33/94 81N74-2

43. Sensitivity per the virus type of strains
Virus types (strains)
Detection
Sensitivity
Influenza virus, TypeA(H5N1)(cultured sample 210HAU) ○
0.2HAU
Influenza virus, TypeA(H5N2)(cultured sample 25HAU)
0.05HAU
Influenza virus, TypeA(H5N3)/HK/80(26~7HAU)
Influenza virus,TypeA(H7N1)/Duck/Hongkong/301/78 (26HAU)
0.1HAU
Influenza virus,TypeA(H9N2)/TK/WS/1/66
0.5HAU
Influenza virus,TypeA(H2N2) /SINGAPORE/1/57
0.25HAU
Influenza virus,TypeA(H13N6)/GULL/MALAND
0.125HAU
Influenza virus,TypeA(H12N5)/DUCK/ALBERTO/60/76
Influenza virus,TypeA(H8N4) /TK/OT/6/18/68
Influenza virus,TypeA(H11N9)/DUCK/MEMPHIS/546/74
Influenza virus,TypeA(H6N5) /SHEARWATER/AUSTRALIER/1/72
0.0625HAU
Influenza virus,TypeA(H10N7)/CHICKEN/GR/N/49
Influenza virus,TypeA(H4N6) /CZECH0/56
Influenza virus,TypeA(H3N6) /DUCK/UKRINE/1/63
Influenza virus,TypeB

44. Comparison data vs. RAT competitor Influenza Virus (strain)
Detection Limit of each virus type
Influenza Virus (strain)
Quidel BD SD
Remark
Type A, H1N1(2475)
1/320
1/640
Better than Quidel
Equal to BD
Type A, H3N2(30135)
1/1280
Type A, H5N1
1/160
1/5120
Better than Quidel, BD
Type A, H5N2
1/10
Type A, H5N3
Equal to Quidel, BD
Type A, H7N1
Equal to Quidel (has thick band)
Less than BD
Type A, H9N2
1/10240
1/20480
Equal to Quidel
Type B
 1/2560 
1/2560

45. 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

46. Clinical Evaluation Studies Summary of Clinical Evaluation Data

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

48. SD BIOLINE Influenza Antigen test
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.

49. 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.

50. mouse monoclonal anti-influenza H5-gold conjugate
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

51. specimen collection & preparation
Nasal swab
Nasal aspirate
Throat swab
Tracheal aspirate (Especially, test results with the tracheal aspirate specimens would be recommendable, because the majority of AIV may exist at the tracheal position.)

52. specimen collection & preparation
If the specimen should be tested later, swab specimens should be placed into 1 ~ 2 ml of transport media or saline by direct extraction.
Transport media : Use of the following transport media has been tested and found to be compatible with SD BIOLINE Influenza Antigen test.
Saline EMEM+1%BSA
PBS EMEM+0.5%BSA
PBS+0.5%BSA Trypticase soy Broth+0.5%BSA
PBS+0.5%Gelatin Trypticase soy Broth+0.5% gelatin

53. Special Precautions
on Specimen collection & preparation
Use of fresh sample is very important for getting accurate results.
The specimen which have ever been thawed after freezing may results in decreased test sensitivity from the deterioration or modification of H5 antigen. So, repeated freezing and thawing of specimen must not be used for this test.
Finally, to get accurate results, specimen should be tested as soon as possible after collection.

54. Test procedure & Interpretation
; nasal swab, throat swab
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.

55. Test procedure & Interpretation
; nasal aspirate, tracheal aspirate
Pipet 100uL of assay diluent and 100uL of aspirate specimen into test tube. And mix well.
Place the Test Strip into the test tube.
Read result at 10 ~ 15 minutes.

56. Test Results Appearance ; Influenza A/H5 positive

57. SD BIOLINE Influenza H5 Limit of Detection : H5N1
(*)minimum detectable level
With H5N1 (ES/03) : virus titer 27 HA unit MDL(*)
32HAU HAU HAU HAU HAU HAU

58. Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen

59. Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen

60. Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen

61. Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen
Case 1 :
At the WHO Collaborating Centre for Reference and Research on Influenza
Dr. Aeron Hurt
Address : 45 Poplar Rd,Parkville, Victoria 3052, Australia
SD H5 kit could detect as below;
A/Chicken/Vietnam #8 (-irradiated) – A(H5N1) – Egg grown
A/Duck/Vietnam #7A (-irradiated) – A(H5N1) – Egg grown
A/?/Vietnam #Pooled (-irradiated) – A(H5N1) – Egg grown
Case 2 :
At the Avian Section, Diagnostic Virology Laboratory National Veterinary Services Laboratories, APHIS, USDA
Dr. Janice C. Pedersen, Microbiologist SD H5 kit could detect as below;
TY/MN H5N2 10-1

62. Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen
Case 3 :
At the ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLA
LOMBARDIA E DELL’EMILIA ROMAGNA “BRUNO UBERTINI”
(ENTE SANITARIO DI DIRITTO PUBBLICO)
Address : Via Bianchi, 9, BRESCIA, ITALY
SD H5 kit could detect as below;
A/ty/It/90302/05/H5N2 (LPAI) - 104,5EID50/ml as detection limit.
Case 4 : At the OIE AIV Reference Laboratory Clinic for bird, reptile, amphibia and fishes Universita"t Giessen, Germany
Justus-Liebig-University Giessen Frankfurter, Germany
Performed by Prof. Dr. E. F. Kaleta,
SD H5 kit could detect as below;
H5Nx: Cell culture supernatant fluids containing H5 virus (H5N2, H5N9, H5N1)
were cpe pos. in chick embryo cell cultures up to 10 to minus three.

63. Applications of Influenza Rapid kits
on Avian Influenza diagnosis programs
Respiratory specimen
RAT by SD BIOLINE Influenza Ag test
In case of emergency that happen to outbreak of AI in the poultry, SD BIOLINE Influenza H5 test should be used directly.
Type A positive
Type B positive
RAT by SD BIOLINE Influenza H5 test
Treatment or Confirm test by RT-PCR/viral culture
H5 positive
negative
Send Samples to Reference Laboratory that participates in WHO/CDC programs for flu/H5 surveillance, immediately
Negative
**WHO recommendations on the use of rapid testing for influenza diagnosis ;
Influenza surveillance should be used to guide the optimal use of RAT (rapid antigen test).
At the beginning of the influenza season or an influenza outbreak, RAT may influence on clinical decisions and contribute to clinical awareness.

64. Advantages as an aid of H5 diagnosis
SD BIOLINE Influenza H5
Advantages as an aid of H5 diagnosis
For the screening test, the Sole H5 Avian Influenza Antigen Rapid Kit in the world
Accurate detection on H5N1 samples isolated from Human infection cases, with High Sensitivity and Specificity
With same kits, we’ve got lots of AI positive cases through HPAI (H5N1~H5N9) detection in the farm, market, or laboratory by use of feces or cloacal swab as veterinary use.
Easy assay procedure: No technical expert and No equipment is required
Labor & Time saving because of fast results

65. Global Rapid Diagnostic Leader SD
THANK YOU