1. Global Rapid Diagnostic Leader SD

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

3. 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.

4. 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

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

6. 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.

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

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

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

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

11. Comparison Table (Influenza RAT)
Q SD BD

12. 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

13. 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

14. 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

15. 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

16. Clinical Evaluation Studies Summary of Clinical Evaluation Data

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

18. 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.

19. 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.

20. 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

21. 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.)

22. 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

23. 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.

24. 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.

25. 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.

26. Test Results Appearance ; Influenza A/H5 positive

27. 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

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

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

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

31. 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

32. 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.

33. 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

34. 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.

35. 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

36. 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

37. 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

38. 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.

39. 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

40. Global Rapid Diagnostic Leader SD
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