Transcript OnSite Dengue IgG/IgM Combo Rapid Test

Dengue virus:
The most important arthropod-borne viral
infection in humans
August 2013
Overview
• Dengue: Global impact and diagnostic needs
• CTK Biotech: The complete solution to dengue diagnosis
• CTK product line: Technical details
•Summary and suggested literature
Dengue is a global health concern endemic to tropical and subtropical areas including Africa, Asia and the Americas. 2.5 billion
people (40% of the world population) are at risk of infection.
Annual Statistics
• 50-100 million infections
reported annually
• 22 thousand deaths
(mainly children)
WHO: The global burden of disease 2004 update
Southeast Asia bears a large portion of the global burden
with Thailand, Indonesia and India already experiencing fatal
outbreaks as peak season approaches.
• Estimated 70% of world’s
serious dengue cases in
2012 were in Asia
• 2013 figures reported
since January are on pace
for a record setting Dengue
season
WHO: The global burden of disease 2004 update
Two of the main reasons for the increase in reported
cases, global spread of the virus and rise in the severity
of cases reported are:
1) Environmental factors and urbanization of areas conducive to
mosquito reproduction  increased risk of infection because
of increased exposure to transmitting mosquitoes
2) All 4 serotypes have been identified in recent outbreaks;
historically only 1 or 2 subtypes were identified in a particular
outbreak  increase in secondary infections which are more
severe than primary infections
Four serotypes of dengue virus exist in the endemic areas of
the world. The virus is arthropod-borne, transmitted by
mosquitos.
Aedes aegypti
• Dengue is a member of the flavivirus family
Human
Gunzman et al. Nature review 2010;
Center for Disease Control (CDC)
• Four serotypes exist (DENV 1, 2, 3, 4)
• The virus is transmitted by tiger mosquitos (Aedes spp.)
Screening and limiting the number of mosquito bites is critical to managing the
spread of the disease.
Primary infection results in mild symptoms and confers immunity
to subsequent infection by the same serotype. Secondary
infections are more severe leading to Dengue hemorrhagic fever.
recovery
2° infection
1° infection
Immunity to 1 serotype
DENV serotype
• Any of the 4 DENV serotypes
Disease
• Symptoms:
Mild (Dengue Fever DF)
Similar to other infection (Flu or malaria)
• Confers immunity against 1 DENV serotype
DENV serotype
• DENV serotype different from 1° infection
Disease
• Symptoms:
Life-threatening (Dengue hemorrhagic fever DHV
and Dengue shock syndrome DSS)
• Antibody enhanced infection
No vaccine is available & treatment is limited to replenishing fluids and electrolytes.
Therefore, early diagnosis that can distinguish between primary and secondary
infections is critical to disease management allowing faster treatment and limit
mortality and morbidity rates.
Dengue infections can be detected at all stages of disease.
Different Ab responses during primary and secondary infections
enable differentiation between the two types of infection.
Disease
onset
Primary dengue infection
Secondary dengue infection
Disease
onset
virus
virus
IgG
IgG
IgM
IgM
0 1 2 3 4 5 6 7 8 9 10
days
30 .. 60...>90 0 1 2 3 4 5 6 7 8 9 10
viral antigen
(Day 1-5)
days
30
.. 60…>90
viral antigen
(Day 1-5)
Anti-dengue IgM
(day 3-30)
Anti-dengue IgG
(from day 7-11 on)
Anti-dengue IgM low and varying
Anti-dengue IgG
(from day 3 on)
Adapted from Sa-Ngasanget al. Epidemiol. Infect. (2006), Gunzman et al. Int. Jour. Inf. disease 2004
Diagnostic needs to manage dengue
• Detection of dengue as early as possible to initiate medical care
• Discrimination of dengue from other infections with similar
symptoms such as Leptospira, rubella
• Detection of all 4 DENV serotypes (DENV 1, 2, 3, 4)
• Detection during all phases of a dengue infection
• Differentiation between primary and secondary dengue
infections
OnSite Rapid Tests offer many advantages compared to other
diagnostic methods: minimal resource requirements, faster time
to results, use in unlimited test settings
Virus
isolation
RT-PCR
ELISA
OnSite Rapid
Test
Sensitivity
high
high
Highmedium
Highmedium
Specificity
high
high
Highmedium
Highmedium
Equipment
required
high
high
medium
low
Training
requirements
high
high
medium
low
Application in
the field
no
no
no
yes
Time
days
6-12h
60-75min
15-25min
Resources
Opportunity
CTK Biotech offers a complete line for the diagnosis of
infection with dengue virus at various disease stages.
OnSite Rapid Tests
Dengue IgG/IgM Combo Rapid Test (R0061C)
- detection and differentiation of anti-dengue IgG, IgM
Duo Dengue Ag-IgG/IgM Rapid Test (R0062C)
- detection and differentiation viral antigens and anti-dengue IgG, IgM
Dengue Ag Rapid Test (R0063C)
- detection of DENV antigens at early stage of infection (1-5 days)
Positivia External Controls
Dengue Ag Rapid Test Control Kit (C0063)
OnSite Dengue Ag Rapid Test
R0063C
OnSite Dengue Ag Rapid Test (R0063C)
Test Overview
Intended use
Qualitatively detects dengue Ag
Specimen type
Serum/Plasma/Whole Blood
Reading time
25 minutes
Performance
Relative Sensitivity: 95.6%,
Relative Specificity: 95.5%
Shelf life
18 months
Package size
30 tests
OnSite Dengue Ag Rapid Test (R0063C)
Test procedure – as easy as 1, 2, 3
Step 1:
Addition of specimen
Step 2:
Addition of sample diluent
Step 3:
Read Result
1 drop serum/plasma
1 drop sample diluent
2 drops whole blood
1 drop sample diluent
Result
25 minutes
OnSite Dengue Ag Rapid Test (R0063C)
Interpretation of Results
Negative
Positive
Invalid
A positive Dengue Ag test result indicates early stage, current infection.
Treatment should be started immediately to minimize severity of symptoms.
OnSite Dengue Ag Rapid Test (R0063C)
Performance Data
OnSite Dengue Ag
Rapid Test
Dengue Ag
EIA Test
Positive
Negative
Total
Positive
66
3
69
Negative
2
43
45
Total
68
46
Relative Sensitivity: 95.6%
Relative Specificity: 95.5%
Overall Agreement: 95.6%
OnSite Dengue Ag Rapid Test (R0063C)
External evaluations performed by independent reference
labs in different geographic regions showed favorable results.
Two leading reference labs in Ecuador and one in Sri Lanka
recently performed independent evaluations of the OnSite
Dengue Ag Rapid Test.
Key findings in the reports:
• 100% agreement with the reference test used for
evaluation
• No cross-reactivity with 7 other infectious disease samples
• Highly sensitive and specific
Positivia Dengue Ag Rapid Test Control Kit
C0063
Positivia Dengue Ag Rapid Test Control Kit C0063
External controls intended for use with OnSite Dengue Ag
Rapid Tests (R0063C, R0062C)
Before testing:
• A new shipment arrives or a new lot is started
• The temperature during shipment or storage of the rapid test falls
outside of the 2-30°C range
• The temperature of the test area falls outside of the 15-30°C
range
• Training new technicians
• Product demonstrations of OnSite Rapid Tests
After testing:
• Confirming results that may conflict with other clinical findings
• Verifying a higher than expected frequency of positive or negative
results
• Investigating the cause of repeated invalid results
Positivia Dengue Ag Rapid Test Control Kit C0063
External controls intended for use with OnSite Dengue Ag
Rapid Tests (R0063C, R0062C)
Contents
Dengue Ag Positive Control
Dengue Ag Negative Control
Physical status
Lyophilized powder
Shelf life
6 months
Storage
2-30°C
OnSite Dengue IgG/IgM Combo Rapid Test
R0061C
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
Intended Use
Intended use
Qualitatively detects &
differentiates IgG & IgM to DENV 1,
2, 3, 4
Antigen used
Proprietary recombinant DENV 1,
2, 3 & 4 Ag
Specimen type
Serum/Plasma/Whole blood
Reading time
25 minutes
IgM Performance
Relative Sensitivity: 96.9%; Relative
Specificity: 98.9%
IgG Performance
Relative Sensitivity: 97.3%
Relative Specificity: 99.3%
Shelf life
18 months
Package size
30 tests
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
Test procedure – as easy as 1, 2, 3
Step 1:
Addition of specimen
Step 2:
Addition of sample diluent
Step 3:
Read Result
Result
5 µL serum/plasma
25 minutes
3 drops sample
diluent
5 µL whole blood
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
Interpretation of Results
Negative
IgM
Positive
IgG
Positive
IgM, IgG
Positive
Invalid
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
Performance Data for IgM test
OnSite Dengue IgG/IgM
Combo Rapid Test
IgM EIA Test
Positive
Negative
Total
Positive
31
1
32
Negative
3
279
282
Total
34
280
314
Relative Sensitivity: 96.9%
Relative Specificity: 98.9%
Overall Agreement: 98.7%
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
Performance Data for IgG test
OnSite Dengue IgG/IgM
Combo Rapid Test
IgG EIA Test
Positive
Negative
Total
Positive
36
1
37
Negative
2
287
289
Total
38
288
326
Relative Sensitivity: 97.3%
Relative Specificity: 99.3%
Overall Agreement: 99.1%
OnSite Dengue IgG/IgM Combo Rapid Test (R0061C)
External evaluations performed by independent reference
labs in different geographic regions showed favorable results
Reference labs in Ecuador and Taiwan recently performed
independent evaluations of the OnSite Dengue IgG/IgM
Rapid Test.
Key findings in the reports:
• 100% agreement with the reference test used for
evaluation
• Report from Taiwan to be published
OnSite Duo Dengue Ag-IgG/IgM Rapid Test (R0062C)
Combines the dengue Ag and IgG/IgM tests in a single cassette
Intended use
Qualitatively detects &
differentiates IgG & IgM antidengue virus and dengue Ag
Antigen used
Proprietary recombinant DENV 1,
2, 3 & 4 Ag
Specimen type
Serum/Plasma/Whole blood
Reading time
25 minutes
Shelf life
18 months
Package size
30 tests
Additional reasons to choose CTK products
Experience
CTK Biotech has extensive experience with infectious disease diagnostics (Over 90% of
the product line is focused on infectious diseases)
Quality
Production of ALL essential components in-house at our facility in San Diego, CA (USA).
ISO 13485 Certified
In compliance with US FDA GMP/QSR guidelines
CE marked products
Guarantees excellent control over test quality, supply and consistency between lots
Innovation
CTK Biotech is committed to constantly improve our products by research and
incorporation of novel, cutting-edge technologies.
Summary of Key Points
• Dengue is of tremendous medical importance and affects about 40% of the world
population. Early diagnosis is critical for managing patient care and controlling disease
spread.
• CTK Biotech designed, developed and validated a product line for diagnosis of dengue:
1. At different stages of disease
2. In primary and secondary infections
• CTK Biotech produces all core components in a FDA approved facility in San Diego.
1. Guarantees availability and quality of products
2. Improvement of current and development of novel product lines
Suggested Literature
•Center for Disease Control
(http://www.cdc.gov./dengue/clinicallab/laboratory.html
• Dengue: a continuing global threat. Guzman et al. 2010. Nature reviews
Microbiology
• Dengue viral infections. Malavige et al. 2004. Postgradmedj. 2004
Contact Us
Phone: (858) 457-8698
Fax: (858) 535-1739
Email: [email protected]
Web: ctkbiotech.com