2RAT (Rapid Antigen Test) SD BIOLINE Influenza Antigen (type A & B) SD BIOLINE Influenza H5 (A/H5N1)
3SD BIOLINE Influenza Antigen Kit SD BIOLINE Influenza Antigen rapid test isa chromatographic immunoassay for the differential and qualitative detection ofinfluenza virus type A and type B antigens directly fromnasal swab specimens,throat swab specimens,nasal/nasopharyngealaspirate specimens.
4mouse monoclonal anti-influenza A/B-gold conjugate Test Principle & Major active ingredient- Detection by Direct Sandwich Systemmouse monoclonal anti-influenza A/B-gold conjugateGoldGoldGoldFlu A AgFlu B Agin specimenin specimenmouse monoclonalanti-influenza Bmouse monoclonalanti-influenza AC line B line(Influenza B type) A line(Influenza A type)Target materials : Influenza antigen (type Aband B)in respiratory specimen
5Test Results Appearance Negative Influenza type A Influenza type Bpositive positive
6Test 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.
13Sensitivity per the virus type of strains Virus types (strains)DetectionSensitivityInfluenza virus, TypeA(H5N1)(cultured sample 210HAU)○0.2HAUInfluenza virus, TypeA(H5N2)(cultured sample 25HAU)0.05HAUInfluenza virus, TypeA(H5N3)/HK/80(26~7HAU)Influenza virus,TypeA(H7N1)/Duck/Hongkong/301/78 (26HAU)0.1HAUInfluenza virus,TypeA(H9N2)/TK/WS/1/660.5HAUInfluenza virus,TypeA(H2N2) /SINGAPORE/1/570.25HAUInfluenza virus,TypeA(H13N6)/GULL/MALAND0.125HAUInfluenza virus,TypeA(H12N5)/DUCK/ALBERTO/60/76Influenza virus,TypeA(H8N4) /TK/OT/6/18/68Influenza virus,TypeA(H11N9)/DUCK/MEMPHIS/546/74Influenza virus,TypeA(H6N5) /SHEARWATER/AUSTRALIER/1/720.0625HAUInfluenza virus,TypeA(H10N7)/CHICKEN/GR/N/49Influenza virus,TypeA(H4N6) /CZECH0/56Influenza virus,TypeA(H3N6) /DUCK/UKRINE/1/63Influenza virus,TypeB
14Comparison data vs. RAT competitor Influenza Virus (strain) Detection Limit of each virus typeInfluenza Virus (strain)QuidelBDSDRemarkType A, H1N1(2475)1/3201/640Better than QuidelEqual to BDType A, H3N2(30135)1/1280Type A, H5N11/1601/5120Better than Quidel, BDType A, H5N21/10Type A, H5N3Equal to Quidel, BDType A, H7N1Equal to Quidel (has thick band)Less than BDType A, H9N21/102401/20480Equal to QuidelType B 1/2560 1/2560
15Clinical 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 & OverseasVietnam (H5)HongKongThailand, etc
16Clinical Evaluation Studies Summary of Clinical Evaluation Data
17Clinical evaluation studies results performed at National Institute of Hygiene and Epidemiology, Vietnam (including H5 Human cases)*Test period : Dec.2004 ~ Dec.2005
18SD BIOLINE Influenza Antigen test Competitiveness ofSD BIOLINE Influenza Antigen testWhy 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 BSD kit is very useful as POCT (point of care testing), on-site test.
19SD BIOLINE Influenza H5 kit SD BIOLINE Influenza H5 rapid test isa 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.
20mouse monoclonal anti-influenza H5-gold conjugate Test Principle & Major active ingredient- Detection by Direct Sandwich Systemmouse monoclonal anti-influenza H5-gold conjugateGoldGoldFlu H5 Agin specimenmouse monoclonalanti-influenza H5C line T line (Influenza A/H5)Target materials : Hemagglutinin H5 antigenof avian influenza (AI) virus in respiratory specimen
21specimen collection & preparation Nasal swabNasal aspirateThroat swabTracheal aspirate (Especially, test results with the tracheal aspirate specimens would be recommendable, because the majority of AIV may exist at the tracheal position.)
22specimen 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
23Special Precautionson Specimen collection & preparationUse 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.
24Test procedure & Interpretation ; nasal swab, throat swabTransfer 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.
25Test procedure & Interpretation ; nasal aspirate, tracheal aspiratePipet 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.
27SD BIOLINE Influenza H5 Limit of Detection : H5N1 (*)minimum detectable levelWith H5N1 (ES/03) : virus titer 27 HA unit MDL(*)32HAU HAU HAU HAU HAU HAU
28Evaluation data on AIV H5 antigen SD BIOLINE Influenza H5Evaluation data on AIV H5 antigen
29Evaluation data on AIV H5 antigen SD BIOLINE Influenza H5Evaluation data on AIV H5 antigen
30Evaluation data on AIV H5 antigen SD BIOLINE Influenza H5Evaluation data on AIV H5 antigen
31Evaluation data on AIV H5 antigen SD BIOLINE Influenza H5Evaluation data on AIV H5 antigenCase 1 :At the WHO Collaborating Centre for Reference and Research on InfluenzaDr. Aeron HurtAddress : 45 Poplar Rd,Parkville, Victoria 3052, AustraliaSD 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 grownCase 2 :At the Avian Section, Diagnostic Virology Laboratory National Veterinary Services Laboratories, APHIS, USDADr. Janice C. Pedersen, Microbiologist SD H5 kit could detect as below;TY/MN H5N2 10-1
32Evaluation data on AIV H5 antigen SD BIOLINE Influenza H5Evaluation data on AIV H5 antigenCase 3 :At the ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLALOMBARDIA E DELL’EMILIA ROMAGNA “BRUNO UBERTINI”(ENTE SANITARIO DI DIRITTO PUBBLICO)Address : Via Bianchi, 9, BRESCIA, ITALYSD 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, GermanyJustus-Liebig-University Giessen Frankfurter, GermanyPerformed 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.
33Poultry AIV – human infection Surveillance of Epidemiology case study by Korea CDC <Step 1>Surveillance on Central Hospital around region of outbreak of AIVReview & Collection of hospitalized recordsCollection of blood or respiratory specimen from possible case or not-caused ARDSLaboratory diagnosis at CDC, Dept. Of infectious disease control
34Poultry 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.
35Diagnosis of AIV infection to Human Virus isolation in tissue culture cells, or virus inoculation into eggViral nucleic acid : RT-PCRHemagglutination Inhibition test (HI)Neutralization (NT)Infectious virusELISA:recombinant antigenWestern blot
36Diagnosis of AIV infection to Human Sample collectionDescriptionSpecimenCollection timeVirus isolationRespiratory specimenEarly stage of onsetNucleic acidRAT (rapid antigen test)SerologicalSerumacute : Early stage of onsetcovalescent : after 3 weeks
37First, by Rapid Antigen Testing Diagnosis Flow chartSpecimen collectionRespiratory specimenSerumFirst, by Rapid Antigen TestingHIParticipates in WHO/CDC programs for flu surveillanceRT-PCR /Virus cultureNT
38Applications of Influenza Rapid kits on Avian Influenza diagnosis programsRespiratory specimenRAT by SD BIOLINE Influenza Ag testIn case of emergency that happen to outbreak of AI in the poultry, SD BIOLINE Influenza H5 test should be used directly.Type A positiveType B positiveRAT by SD BIOLINE Influenza H5 testTreatment or Confirm test by RT-PCR/viral cultureH5 positivenegativeSend Samples to Reference Laboratory that participates in WHO/CDC programs for flu/H5 surveillance, immediatelyNegative**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.
39Advantages as an aid of H5 diagnosis SD BIOLINE Influenza H5Advantages as an aid of H5 diagnosisFor the screening test, the Sole H5 Avian Influenza Antigen Rapid Kit in the worldAccurate detection on H5N1 samples isolated from Human infection cases, with High Sensitivity and SpecificityWith 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 requiredLabor & Time saving because of fast results