Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Similar presentations


Presentation on theme: "Global Rapid Diagnostic Leader SD. SD BIOLINE Influenza Antigen (type A & B) SD BIOLINE Influenza H5 (A/H5N1) RAT (Rapid Antigen Test)"— Presentation transcript:

1 Global Rapid Diagnostic Leader SD

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

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 - 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 in specimen Flu A Ag mouse monoclonal anti-influenza A Test Principle & Major active ingredient

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

6 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.

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

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

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

10 Interpretation of Test Results A/H1N1 A/H3N2 B Neg.

11 Comparison Table (Influenza RAT) Q SD BD

12 Virus types (strains)DetectionSensitivity 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(2 7 HAU) (cultured sample) ○ 0.5HAU Influenza virus,TypeA(H3N2) HN30109 (cultured sample) ○ 0.125HAU Influenza virus,TypeA(H3N2) HN30135 (cultured sample) ○ HAU Influenza virus,TypeA(H3N2) HN30240 (cultured sample) ○ 0.25HAU Influenza virus, TypeA(H3N2)/Hongkong/8/68 VR544(2 6 HAU) (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

13 Virus types (strains)DetectionSensitivity Influenza virus, TypeA(H5N1)(cultured sample 2 10 HAU) ○ 0.2HAU Influenza virus, TypeA(H5N2)(cultured sample 2 5 HAU) ○ 0.05HAU Influenza virus, TypeA(H5N3)/HK/80(2 6~7 HAU) ○ 0.05HAU Influenza virus,TypeA(H7N1)/Duck/Hongkong/301/78 (2 6 HAU) ○ 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 ○ HAU 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

14 Detection Limit of each virus type Influenza Virus (strain) QuidelBDSDRemark Type A, H1N1(2475)1/3201/640 Better than Quidel Equal to BD Type A, H3N2(30135)1/6401/1280 Better than Quidel Equal to BD Type A, H5N11/1601/3201/5120Better than Quidel, BD Type A, H5N21/10 1/640Better than Quidel, BD Type A, H5N31/1280 Equal to Quidel, BD Type A, H7N11/6401/12801/640 Equal to Quidel (has thick band) Less than BD Type A, H9N21/102401/204801/10240 Equal to Quidel Less than BD Type B 1/2560 Equal to Quidel, BD Comparison data vs. RAT competitor

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 Summary of Clinical Evaluation Data Clinical Evaluation Studies

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 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 - 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 in specimen Flu H5 Ag mouse monoclonal anti-influenza H5 Test Principle & Major active ingredient

21 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.)

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. SalineEMEM+1%BSA PBSEMEM+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 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.

24 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.

25 Test procedure & Interpretation ; nasal aspirate, tracheal aspirate ① Pipet 100uL of assay diluent and 100uL of aspirate specimen into test tube. And mix well. ② Place the Test Strip into the test tube. ③ Read result at 10 ~ 15 minutes.

26 Test Results Appearance ; Influenza A/H5 positive

27 SD BIOLINE Influenza H5 Limit of Detection : H5N1 With H5N1 (ES/03) : virus titer 2 7 HA unit MDL(*) 32HAU 16HAU 8HAU 4HAU 2HAU 1HAU (*)minimum detectable level

28 SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen

29 SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen

30 SD BIOLINE Influenza H5 Evaluation data on AIV H5 antigen

31 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 H5N

32 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) ,5 EID 50 /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 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 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

35 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

36 DescriptionSpecimenCollection time Virus isolation Respiratory specimen Early stage of onset Nucleic acid RAT (rapid antigen test) SerologicalSerum acute : Early stage of onset covalescent : after 3 weeks Sample collection Diagnosis of AIV infection to Human

37 Specimen collection Respiratory specimenSerum HI NTRT-PCR / Virus culture Participates in WHO/CDC programs for flu surveillance First, by Rapid Antigen Testing Diagnosis Flow chart

38 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 positiveType B positive RAT by SD BIOLINE Influenza H5 test Treatment or Confirm test by RT-PCR/viral culture H5 positivenegative Treatment or Confirm test by RT- PCR/viral culture Send Samples to Reference Laboratory that participates in WHO/CDC programs for flu/H5 surveillance, 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.

39 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

40 Global Rapid Diagnostic Leader SD THANK YOU


Download ppt "Global Rapid Diagnostic Leader SD. SD BIOLINE Influenza Antigen (type A & B) SD BIOLINE Influenza H5 (A/H5N1) RAT (Rapid Antigen Test)"

Similar presentations


Ads by Google