Global Rapid Diagnostic Leader SD. Company Introduction.

Global Rapid Diagnostic Leader SD

Company Introduction

Product Line

Products List

Hepatitis B, C HBsAg, Anti-HBs, HCV HBeAg/

HBsAg Infectious Disease

HIV-1/2, Syphilis, TB, Malaria,

H.pylori, Chlamydia Ag, Dengu

e IgG/IgM, Leprosy, Salmonell

a typhi, Rotavirus, Tetanus, Infl

uenza/H5, RSV, Rubella IgG/Ig

M Tumor Marker

AFP, CEA, PSA, CEA/AFP, F

OB Drug of Abuse

MOP, MET, AMP, COC, THC,

MET/THC, MDMA (ecstasy) Fertility Hormone

hCG, LH, FSH Veterinary Tests

Heartworm, Distemper, Parvo

virus, FMD

Rapid Tests

• Urocolor (1~11para) Urometer 600

Urine Strip & reader

New Products Development

Expanding Into NEWbusiness fields

Present(In 2006)

New Rapid Test

• New Patent Device Fromat• Rubella IgG/IgM, Torch, Rota/Adeno, • Strep A, S. pnemoniae

DNA Chip

• Infectious Disease DNA Chip

• Congenital Disease DNA Chip

• Tumor DNA Chip

Long term (In 2008~ )

Short term(In 2006~2007)

• 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

Protein Chip

Blood Glucose Meter

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

Int’l Quality Approval

Item WHO Evaluation CE Mark USA FDA

HIV1/2 Completed Under process -

HCV Completed - -

Syphilis Completed Completed -

HBsAg Completed - -

Malaria - Completed -

hCG - Completed Completed

H.pylori - Completed -

Dengue - Completed -

Influenza - Completed

Rota - Completed -

Urine - Completed Under process

TB Under process - -

““Products Evaluation, Registration and Approval ”

Sales Network

“ 125 distributors in 75 Countries ”

“ 12 Domestic distributors”

Asia 18 countries

China, Japan, TaiwanThailand, India, Nepal Vietnam, the Philippines Bangladesh, Sri LankaMyanmar, PakistanIndonesia, MalaysiaHong Kong, MongolAustralia.Singapore, …

Middle East 12 countries

Iran, Syria, YemenJordan, Israel, Lebanon. PalestineSaudi Arabia,QatarEgypt. U.A.E.Oman,

Europe 17 countries

Germany, Swiss, ItalyRomania, Poland, Turkey, Finland, UK, Lithuania, Russia, Croatia, France, Bulgaria,Denmark,Netherlands

America/ Africa28 countries

USA, Canada ,Mexico, ,Panama, Bahamas,Guyana Brazil, Colombia, GuatemalaPeru, Venezuela,Paraguay, Honduras,Ecuador…..Cameron, Sudan, NigeriaMozambique, South AfricaUganda, Kenya, TanzaniaGhana, Benin, Burkina FasoMalawi, Zimbabwe…

Sales Network in Overseas Markets

Domestic market

12 Distributors by Region

Domestic Sales Network

SuWon

Seoul

DaeJeon DaeGu

Busan

GwangJu

JeunJu

WonJu

ChungJu

KangNung

Changwon

Jeju

Influenza virus

General

History

Diagnostic Tools

AIV _ Human Infection

Structure of Influenza virus

HA Antigen : Help virus absorption into cells NA Antigen : help virus segregation from cells

Influenza Virus

Acute respiratory illness caused by Influenza viruses A subtype or B subtype

(Karl G Nicholson, et al Lancet 2003; 362: 1733-45)

•Major : A (H, N)

•Human Infection•H1N1

•H3N2

•H2N2

•H5N1

N9

H10

H11

H12

H13

H14

H15

N1

N2

N3

N4

N5

N6

N7

N8

H1

H2

H3

H4

H5

H6

H7

H8

H9

Influenza Outbreak in 20th centuries

H1N1 H1N1

H2N2

H3N2

1918: “Spanish Flu” 1957: “Asian Flu” 1968: “Hong Kong Flu”

2003~4: “AIV H5”

H5N1

http://www.i-s-b.org/wissen/broschuere/32.gif

Major Influenza Pandemics Period

“Spanish Flu” Pandemic (1918-1919)

World-wide population 2 bil.

(100 %)

Infected polulation 0.4 bil. (20 %)

Deaths 20-40 mil. (1-2 %)

*Outbreak in healthy young people, in the majority of cases

http://www.i-s-b.org/wissen/broschuere/32.gif

Killed an estimated more than 1 mil.

*Outbreak in old people, or patients with chronic disease, in the majority of cases

‘Asian / HongKong Flu’ Pandemic (1957, 1968)

Outbreak of HongKong A/H5N1 (1997)

• Infection – 18

• Death- 6

• Protective slaughter on 1.

5 mil. Chicken

• No infection between hu

man

http://news.bbc.co.uk/olmedia/1335000/images/_1337472_chickens300ap.jpg

Outbreak of Vietnam A/H5N1 (2003~5)

• Infection – 93

• Death- 42

• 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

The Latest New Subtype Infection

Number of cases / Influenza H5/N1Number of cases / Influenza H5/N1

•

AIV_ human Infection Mechanism (1)

Migratory birds

poultry

poultry


Migratory birds

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

5-10days

No

Immunofluorescence DFA Antibody Staining

A and B NP swab, nasal wash, bronchial wash, nasal aspirate, sputum

2-4 hours No

RT-PCR A and B NP swab , throat swab, nasal wash, bronchial wash, nasal aspirate, sputum

1-2 days No

Serology A and B paired acute and convalescent serum samples

>2 weeks No

Enzyme Immuno Assay(EIA)

A and B NP swab , throat swab, nasal wash, bronchial wash

2 hours No

RapidDiagnostic Tests

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

<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

• 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

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


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

Diagnostic criteria (WHO, Vietnam 2004. 1.24)

• 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


• Probable Case– Laboratory diagnostic test results on AIV human infection _ Positi

ve (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

Diagnostic criteria (WHO, Vietnam 2004. 1.24)


SD BIOLINE Influenza Antigen (type A & B)SD BIOLINE Influenza H5 (A/H5N1)

RAT (Rapid Antigen Test)

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.

- 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

Test Results AppearanceNegative Influenza type A Influenza type B

positive positive

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.

Sample collection & Test procedure

1. Nasal swab

2. Diluent 300 uL



3. Extraction

4. Discard the swab.



5. Insert test strip into tube.

6. Migration

Interpretation of Test Results

A/H1N1 A/H3N2 B

3+ 2+ 1+ 3+ 2+ 1+ 3+ 2+ 1+ Neg.

Comparison Table (Influenza RAT)

Q SD BD

Virus types (strains) Detection Sensitivity

Influenza virus,TypeA(H1N1) HN2242 (cultured sample) ○ 0.5HAU



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)/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

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

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

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

Summary of Clinical Evaluation Data

Clinical Evaluation Studies

Clinical evaluation studies results performed at National Institute of Hygiene and Epidemiology, Vietnam (including H5 Huma

n cases)*Test period : Dec.2004 ~ Dec.2005

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.

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.

- 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

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.)

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

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.

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.

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.

Test Results Appearance

; Influenza A/H5 positive

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

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


• 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


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,


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.

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.

• 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

Global Rapid Diagnostic Leader SD

THANK YOU

Global Rapid Diagnostic Leader SD. Company Introduction.

Documents

Transcript of Global Rapid Diagnostic Leader SD. Company Introduction.