Download Influenza A/H5 - Global Marketing Services

Global Rapid Diagnostic Leader SD
Company Introduction
Product Line
Products List
Rapid Tests






Hepatitis B, C
HBsAg, Anti-HBs, HCV
HBeAg/HBsAg
Infectious Disease
HIV-1/2, Syphilis, TB, Malaria,
H.pylori, Chlamydia Ag,
Dengue IgG/IgM, Leprosy,
Salmonella typhi, Rotavirus,
Tetanus, Influenza/H5, RSV,
Rubella IgG/IgM
Tumor Marker
AFP, CEA, PSA, CEA/AFP,
FOB
Drug of Abuse
MOP, MET, AMP, COC, THC,
MET/THC, MDMA (ecstasy)
Fertility Hormone
hCG, LH, FSH
Veterinary Tests
Heartworm, Distemper, Parvo
virus, FMD
Urine Strip & reader
• Urocolor (1~11para)
 Urometer 600
New Products Development
Present
(In 2006)
 New Rapid Test
• New Patent Device Fromat
• Rubella IgG/IgM, Torch, Rota/Adeno,
• Strep A, S. pnemoniae
Long term
(In 2008~ )
 Blood Glucose Meter
 DNA Chip
Short term
(In 2006~2007)
 Protein Chip
• 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
Expanding
Into NEW
business fields
• Infectious Disease DNA Chip
• Congenital Disease DNA Chip
• Tumor DNA Chip
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
1 2 C
HIV1/2
Int’l Quality Approval
“Products Evaluation, Registration and 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
-
-
Sales Network
“ 125 distributors in 75 Countries ”
“ 12 Domestic distributors”
Sales Network in Overseas Markets
Domestic Sales Network
Seoul
SuWon
KangNung
WonJu
ChungJu
DaeJeon DaeGu
JeunJu
Busan
GwangJu Changwon
Jeju
Asia 18 countries
China, Japan, Taiwan
Thailand, India, Nepal
Vietnam, the Philippines
Bangladesh, Sri Lanka
Myanmar, Pakistan
Indonesia, Malaysia
Hong Kong, Mongol
Australia.Singapore, …
Middle East
12 countries
Iran, Syria, Yemen
Jordan, Israel,
Lebanon. Palestine
Saudi Arabia,Qatar
Egypt. U.A.E.Oman,
Europe
17 countries
Germany, Swiss, Italy
Romania, Poland,
Turkey, Finland, UK,
Lithuania, Russia,
Croatia, France,
Bulgaria,Denmark,
Netherlands
America/ Africa
28 countries
USA, Canada ,Mexico, ,
Panama, Bahamas,Guyana
Brazil, Colombia, Guatemala
Peru, Venezuela,Paraguay,
Honduras,Ecuador…..
Cameron, Sudan, Nigeria
Mozambique, South Africa
Uganda, Kenya, Tanzania
Ghana, Benin, Burkina Faso
Malawi, Zimbabwe…
Domestic market
12 Distributors
by Region
Influenza virus
General
History
Diagnostic Tools
AIV _ Human Infection
Structure of Influenza virus
Influenza Virus
HA Antigen : Help virus absorption into cells
NA Antigen : help virus segregation from cells
H1
N1
H2
N2
H3
N3
H4
N4
H5
N5
H6
N6
H7
N7
•Major : A (H, N)
H8
N8
•Human Infection
H9
N9
Acute respiratory illness
caused by
Influenza viruses A subtype
or B subtype
•H1N1
•H3N2
•H2N2
•H5N1
(Karl G Nicholson, et al Lancet 2003; 362: 1733-45)
H10
H11
H12
H13
H14
H15
Influenza Outbreak in 20th centuries
1918: “Spanish Flu” 1957: “Asian Flu” 1968: “Hong Kong Flu” 2003~4: “AIV H5”
H5N1
H3N2
H2N2
H1N1
H1N1
Major Influenza Pandemics Period
“Spanish Flu” Pandemic (1918-1919)
World-wide population 2 bil.
(100 %)
Infected polulation 0.4 bil.
(20 %)
Deaths
(1-2 %)
20-40 mil.
*Outbreak in healthy young people,
in the majority of cases
‘Asian / HongKong Flu’ Pandemic (1957, 1968)
Killed an estimated more
than 1 mil.
*Outbreak in old people, or
patients with chronic disease
, in the majority of cases
Outbreak of HongKong A/H5N1 (1997)
• Infection – 18
• Death- 6
• Protective slaughter
on 1.5 mil. Chicken
• No infection between
human
Outbreak of Vietnam A/H5N1 (2003~5)
• Infection – 93
• Death- 42
The Latest New Subtype Infection
• 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
Number of cases / Influenza H5/N1
•
AIV_ human Infection Mechanism (1)
Migratory birds
poultry
AIV_ human Infection Mechanism (2)
Migratory birds
poultry
AIV_ human Infection Mechanism (3)
Migratory birds
poultry
Influenza Diagnostic Table
Influenza Types
Detected
Acceptable
Specimens
Time for
Results
Rapid result
available
A and B
NP swab , throat swab,
nasal wash, bronchial
wash, nasal aspirate,
sputum
5-10
days
No
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
Procedure
Viral culture
Immunofluorescence
DFA Antibody
Staining
Rapid
Diagnostic 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
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.
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
– recombinant antigen
Diagnosis of AIV infection
to Human
Sample collection
Description
Specimen
Collection time
Respiratory
specimen
Early stage of onset
Serum
acute : Early stage of onset
covalescent : after 3 weeks
Virus isolation
Nucleic acid
RAT (rapid
antigen test)
Serological
Diagnosis Flow chart
Specimen collection
Respiratory specimen
Serum
First, by Rapid Antigen Testing
HI
RT-PCR /
Virus culture
NT
Participates in
WHO/CDC
programs for flu
surveillance
Diagnosis of AIV infection
to Human
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
Diagnosis of AIV infection
to Human
Diagnostic criteria
(WHO, Vietnam 2004. 1.24)
• Probable Case
– Laboratory diagnostic test results on AIV human
infection _ Positive (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
RAT (Rapid Antigen Test)
SD BIOLINE Influenza Antigen (type A & B)
SD BIOLINE Influenza H5 (A/H5N1)
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.
Test Principle & Major active ingredient
- Detection by Direct Sandwich System
mouse monoclonal anti-influenza A/B-gold conjugate
Gold
Gold
Gold
Flu B Ag in specimen
mouse
monoclonal
anti-influenza B
C line
B line(Influenza B type)
Flu A Ag in specimen
mouse
monoclonal
anti-influenza A
A line(Influenza A type)
-Target materials : Influenza antigen (type Aband B)
in respiratory specimen
Test Results Appearance
Negative
Influenza type A
positive
Influenza type B
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
2. Diluent 300 uL
1. Nasal swab
SD BIOLINE Influenza Antigen Kit
Sample collection & Test procedure
4. Discard the swab.
3. Extraction
SD BIOLINE Influenza Antigen Kit
Sample collection & Test procedure
6. Migration
5. Insert test strip into tube.
Interpretation of Test Results
A/H1N1
3+ 2+ 1+
A/H3N2
3+
2+ 1+
3+
B
2+
1+
Neg.
Comparison Table (Influenza RAT)
Q
SD
BD
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
○
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
Virus types (strains)
Detection
Sensitivity
Influenza virus, TypeA(H5N1)(cultured sample 210HAU)
○
0.2HAU
Influenza virus, TypeA(H5N2)(cultured sample 25HAU)
○
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
0.05HAU
Comparison data vs. RAT competitor
Detection Limit of each virus type
Influenza Virus
(strain)
Quidel
BD
SD
Type A, H1N1(2475)
1/320
1/640
1/640
Better than Quidel
Equal to BD
Type A, H3N2(30135)
1/640
1/1280
1/1280
Better than Quidel
Equal 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
Equal to Quidel (has
thick band)
Less than BD
Remark
Type A, H7N1
1/640
1/1280
1/640
Type A, H9N2
1/10240
1/20480
1/10240
Equal to Quidel
Less than BD
Type B
1/2560
1/2560
1/2560
Equal to Quidel, BD
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
Clinical Evaluation Studies
Summary of Clinical Evaluation Data
Used methods for detection of influenza virus and results
Viral Culture and/or RT-PCR
POS
SD KIT
Quidel KIT
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
NEG
216
3
213
5
211
TOTAL
341
117
224
116
225
Sensitivity
91.2% (114/125) 88.8% (111/125)
Specificity
98.6% (213/216) 97.7% (211/216)
Clinical evaluation studies results performed at
National Institute of Hygiene and Epidemiology,
Vietnam (including H5 Human 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 aspirate
specimens on
AI virus human infection
cases.
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
specimen collection & preparation
①
②
③
④
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.)
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
PBS
PBS+0.5%BSA
PBS+0.5%Gelatin
EMEM+1%BSA
EMEM+0.5%BSA
Trypticase soy Broth+0.5%BSA
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
into 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
(*)minimum detectable level
With H5N1 (ES/03) : virus titer 27 HA unit
32HAU
16HAU
+++
+++
8HAU
++
4HAU
++
MDL(*)
2HAU
+
1HAU
+
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
Evaluation data on AIV H5 antigen
SD BIOLINE Influenza H5
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
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.
Applications of Influenza Rapid kits
on Avian Influenza diagnosis programs
Respiratory specimen
RAT by SD BIOLINE
Influenza Ag test
Type A positive
RAT by SD BIOLINE
Influenza H5 test
H5 positive
In case of emergency that
happen to outbreak of AI in the
poultry, SD BIOLINE Influenza H5
test should be used directly.
Type B positive
Negative
Treatment or Confirm test by
RT-PCR/viral culture
negative
Treatment or Confirm test by RTPCR/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.
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
Global Rapid Diagnostic Leader SD
THANK YOU