Global Rapid Diagnostic Leader SD. SD BIOLINE Influenza Antigen (type A & B) SD BIOLINE Influenza H5...
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Transcript of Global Rapid Diagnostic Leader SD. SD BIOLINE Influenza Antigen (type A & B) SD BIOLINE Influenza H5...
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Global Rapid Diagnostic Leader SD
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SD BIOLINE Influenza Antigen (type A & B)SD BIOLINE Influenza H5 (A/H5N1)
RAT (Rapid Antigen Test)
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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/nasopharyngealaspirate specimens.
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- Detection by Direct Sandwich System
C line B line(Influenza B type) A line(Influenza A type)
Flu B Ag
Gold
-Target materials : Influenza antigen (type Aband B) in respiratory specimen
mouse monoclonal anti-influenza B
mouse monoclonal anti-influenza A/B-gold conjugate
Gold
Gold
in specimen in specimenFlu A Ag
mouse monoclonal anti-influenza A
Test Principle & Major active ingredient
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Test Results AppearanceNegative Influenza type A Influenza type B
positive positive
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Test procedure & Interpretation
① Transfer assay diluent into test tube (approximately 300uL).
② Insert the patient swab sample into the test tube and mix well.
③ Place the Test Strip into the test tube.
④ Read result at 10 ~ 15 minutes.
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Sample collection & Test procedure
1. Nasal swab
2. Diluent 300 uL
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SD BIOLINE Influenza Antigen Kit
Sample collection & Test procedure
3. Extraction
4. Discard the swab.
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SD BIOLINE Influenza Antigen Kit
Sample collection & Test procedure
5. Insert test strip into tube.
6. Migration
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Interpretation of Test Results
A/H1N1 A/H3N2 B
3+ 2+ 1+ 3+ 2+ 1+ 3+ 2+ 1+ Neg.
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Comparison Table (Influenza RAT)
Q SD BD
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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 ○ 0.5HAU
Influenza virus, TypeA(H1N1)Beijing/262/95 81N73-2 ○ 0.5HAU
Influenza virus, TypeA(H1N1)/WS/33 VR1520(27HAU) (cultured sample) ○ 0.5HAU
Influenza virus,TypeA(H3N2) HN30109 (cultured sample) ○ 0.125HAU
Influenza virus,TypeA(H3N2) HN30135 (cultured sample) ○ 0.0625HAU
Influenza virus,TypeA(H3N2) HN30240 (cultured sample) ○ 0.25HAU
Influenza virus, TypeA(H3N2)/Hongkong/8/68 VR544(26HAU) (cultured sample) ○ 0.5HAU
Influenza virus, TypeA(H3N2)/Shangdong/9/93 81N74 ○ 0.25HAU
Influenza virus, TypeA(H3N2)/Panama/2007/99 81N74-1 ○ 0.125HAU
Influenza virus, TypeA(H3N2)Kiev/301/94 like/Johannesburg/33/94 81N74-2 ○ 0.125HAU
Sensitivity per the virus type of strains
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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) ○ 0.05HAU
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 ○ 0.05HAU
Influenza virus,TypeA(H8N4) /TK/OT/6/18/68 ○ 0.25HAU
Influenza virus,TypeA(H11N9)/DUCK/MEMPHIS/546/74 ○ 0.125HAU
Influenza virus,TypeA(H6N5) /SHEARWATER/AUSTRALIER/1/72 ○ 0.0625HAU
Influenza virus,TypeA(H10N7)/CHICKEN/GR/N/49 ○ 0.5HAU
Influenza virus,TypeA(H4N6) /CZECH0/56 ○ 0.25HAU
Influenza virus,TypeA(H3N6) /DUCK/UKRINE/1/63 ○ 0.125HAU
Influenza virus,TypeB ○ 0.1HAU
Sensitivity per the virus type of strains
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Detection Limit of each virus type
Influenza Virus (strain)
Quidel BD SD Remark
Type A, H1N1(2475) 1/320 1/640 1/640Better than Quidel Equal to BD
Type A, H3N2(30135) 1/640 1/1280 1/1280Better than QuidelEqual to BD
Type A, H5N1 1/160 1/320 1/5120 Better than Quidel, BD
Type A, H5N2 1/10 1/10 1/640 Better than Quidel, BD
Type A, H5N3 1/1280 1/1280 1/1280 Equal to Quidel, BD
Type A, H7N1 1/640 1/1280 1/640Equal to Quidel (has thick band)Less than BD
Type A, H9N2 1/10240 1/20480 1/10240Equal to QuidelLess than BD
Type B 1/2560 1/2560 1/2560 Equal to Quidel, BD
Comparison data vs. RAT competitor
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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
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POS NEG POS NEG
Type A H3 74 70 4 66 8
Type A H5 12 10 2 9 3
Type B 39 34 5 36 3
Sub Total 125 114 11 111 14
216 3 213 5 211
341 117 224 116 225
91.2% (114/ 125) 88.8% (111/ 125)
Specificity 98.6% (213/ 216) 97.7% (211/ 216)
POS
NEG
TOTAL
Sensitivity
Used methods for detection of influenza virus and results
Viral Culture and/ or RT-PCRSD KIT Quidel KIT
Summary of Clinical Evaluation Data
Clinical Evaluation Studies
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Clinical evaluation studies results performed at National Institute of Hygiene and Epidemiology, Vietnam (including H5 Huma
n cases)*Test period : Dec.2004 ~ Dec.2005
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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.
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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 aspiratespecimens onAI virus human infectioncases.
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- Detection by Direct Sandwich System
C line T line (Influenza A/H5)
-Target materials : Hemagglutinin H5 antigen of avian influenza (AI) virus in respiratory specimen
mouse monoclonal anti-influenza H5-gold conjugate
Gold
Gold
in specimenFlu H5 Ag
mouse monoclonal anti-influenza H5
Test Principle & Major active ingredient
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specimen collection & preparation
① Nasal swab
② Nasal aspirate
③ Throat swab
④ Tracheal aspirate (Especially, test results with the tracheal
aspirate specimens would be recommendable, because the
majority of AIV may exist at the tracheal position.)
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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%BSAPBS EMEM+0.5%BSAPBS+0.5%BSA Trypticase soy Broth+0.5%BSAPBS+0.5%Gelatin Trypticase soy Broth+0.5% gelatin
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Special Precautions on Specimen collection & preparation
① Use of fresh sample is very important for getting
accurate results.
② 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.
③ Finally, to get accurate results, specimen should be
tested as soon as possible after collection.
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Test procedure & Interpretation; nasal swab, throat swab
① Transfer assay diluent into test tube (approximately 300uL).
② Insert the patient swab sample into the test tube and mix well.
③ Place the Test Strip into the test tube.
④ Read result at 10 ~ 15 minutes.
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Test procedure & Interpretation; nasal aspirate, tracheal aspirate
① Pipet 100uL of assay diluent and 100uL of aspirate specimen int
o test tube. And mix well.
② Place the Test Strip into the test tube.
③ Read result at 10 ~ 15 minutes.
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Test Results Appearance
; Influenza A/H5 positive
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SD BIOLINE Influenza H5 Limit of Detection : H5N1
With H5N1 (ES/03) : virus titer 27 HA unit MDL(*)
32HAU 16HAU 8HAU 4HAU 2HAU 1HAU
+++ +++ ++ ++ + +
(*)minimum detectable level
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SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen
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SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen
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SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen
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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 grownA/Duck/Vietnam #7A (-irradiated) – A(H5N1) – Egg grownA/?/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
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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, 25124 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.
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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
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<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
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• 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 infectionto Human
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Description Specimen Collection time
Virus isolation
Respiratory specimen
Early stage of onsetNucleic acid
RAT (rapid antigen test)
Serological Serumacute : Early stage of onsetcovalescent : after 3 weeks
Sample collection
Diagnosis of AIV infectionto Human
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Specimen collection
Respiratory specimen Serum
HI
NTRT-PCR /
Virus culture
Participates in WHO/CDC programs for flu surveillance
First, by Rapid Antigen Testing
Diagnosis Flow chart
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Applications of Influenza Rapid kits on Avian Influenza diagnosis programs
Negative
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
Treatment or Confirm test by RT-PCR/viral culture
Send Samples to Reference Laboratory that participates in WHO/CDC programs for flu/H5 surveill
ance, immediately
**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.
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• 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
SD BIOLINE Influenza H5 Advantages as an aid of H5 diagnosis
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Global Rapid Diagnostic Leader SD
THANK YOU