Panbio Dengue Duo Cassette
Product specifications
Name:
Cat. No.
Expiry:
Storage:
Antigen:
Sample:
Test time:
Kit size:
Procedure:
Dengue Duo Cassette
R-DEN03D
15 months
2 – 30°C (room temperature, below 30°C)
Recombinant Dengue 1 - 4
Plasma, serum or whole blood
15 minutes
25 tests & MicroSafe tubes, 1 bottle of buffer
2 well cassette, 10uL serum, 2 drops of buffer
Product now available!
Features
• The Dengue Duo Cassette has a number of benefits
over the current Dengue Strip Test.
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–
–
–
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Cassette test is 15 mins rather than 30 mins
Whole blood, serum or plasma may be used
No test tube required
15 month expiry
Wide storage range (2 – 30C)
Cassette v strip
Format
Cassette
Strip
Format
IgM, IgG & Control line
IgM, IgG & Control line
Procedure
3 steps
3 steps
Test time
15 minutes
Up to 30 minutes
Sample
Serum only
Additional requirements
Serum, plasma or whole
blood
All components supplied
Expiry
15 months
12 months
Storage
2 - 30C
2 - 8C
Performance
Overall more sensitive
for dengue than strip.
Laboratory & clinician
Good sensitivity and
specificity.
Laboratory
Customer
Test tube required
Positioning
• The cassette test will be positioned as being the “No. 1
for fast dengue diagnosis anywhere, anytime.”
• The key features of the product, whole blood, room
temperature storage, result in 15 minutes and no
additional materials needed to run a test, should be
highlighted.
• Key sales pieces comparing the cassette test to the
strip test with respect to performance and format will
be prepared. Publications and scientific presentations
are planned to enforce confidence in the product.
• Comparisons between competing rapid test products
will be done to further position Panbio as No. 1 in
dengue.
Positioning
“No. 1 for fast dengue diagnosis anywhere, anytime.”
• True point-of-care diagnosis
– Whole blood, serum or plasma may be used
– Kit contains all that is needed to run a test
– Wide storage temperature range (2 – 30°C)
• Reliable
– From Panbio: No 1 in dengue
– >90% sensitivity and specificity1
• Fast and meaningful results
– Results in 15 minutes
– Differentiation between primary and secondary dengue can
help predict disease severity.
Procedure
Click here to view as flash movie
Buffer addition
• Hold the buffer bottle vertically and 1 cm above
the square well.
• Add 2 drops of buffer to the square well at the
base of the cassette
– Incorrect addition of buffer can cause the test not to
work properly
Interpretation
The interpretation is the same as for the strip test
Evaluation sites
• SITE 1
– WHO Collaborating Centre for Arbovirus Reference and
Research,Department of Medical Microbiology, Faculty Of
Medicine,University Of Malaya, Kuala Lumpur, Malaysia
– Chief investigator: Prof. Shamala Devi.
• SITE 2
– Hospitals in Sri Lanka
– Chief investigator: Prof. Sunil Chandra
SITE 1: Malaysia evaluation
Study overview
• Total of 250 serum samples were tested on the
Dengue Duo Cassette and Dengue Duo IgM & IgG
ELISA
• HAI characterised
– 30 paired primary dengue sera
– 30 paired secondary dengue sera
– 80 negative samples from patients thought to have dengue
clinically but proved not to on laboratory testing
• Cross reactivity panel
– malaria (n=10), typhoid (n=10), rubella (n=10), herpes
(n=10), measles (n=10), leptospirosis (n=7) and scrub
typhus (n=2)
SITE 1: Malaysia evaluation
Results
SITE 1: Malaysia evaluation
Conclusion
• Dengue Duo Cassette performed similarly to the
Dengue Duo ELISA and demonstrated a high
sensitivity and specificity
• No significant cross reactivity issues were identified
• The cassette has the ability to aid in the differentiation
of primary and secondary dengue virus infection. In
this trial, the cassette was able to correctly identify
70.8% of primary dengue infections and 86.7% of
secondary dengue infections.
• The Panbio Dengue Duo Cassette has good utility in
the detection of primary and secondary dengue and is
a valuable field based assay to support the clinical
evaluation of dengue virus infections.
SITE 2: Sri Lanka
Study overview
• 209 sera collected from inpatients at a hospital setting
in Sri Lanka
• The cassette was assessed for its capacity to detect
and differentiate presumptive primary and secondary
dengue fever
• Cassette was evaluated against the Panbio Dengue
Duo Dengue Duo IgM & IgG ELISA.
SITE 2: Specificity (non-dengue sera)
SITE 2: Sensitivity & specificity
with serum from hospital settings
SITE 2: Summary of study
• 94% sensitivity
• 93.5% specificity
• The three-step test can utilise serum, plasma or whole
blood, with results obtained in less than 15 minutes.
• A publication on the Dengue Duo Cassette is available
– Garcia M. et al. (2005) Evaluation of a field test for the
detection of dengue antibodies. Arbovirus Research in
Australia. 9:111-7.
Summary
• Panbio Dengue Duo Cassette now available
• Highly sensitive and specific
• Offers considerable benefits over the current strip test
Commonly Asked Questions
about Panbio dengue tests...
Q What happens if I don’t read the Dengue Rapid Tests
at the correct time (ie 15 minutes for cassette and 15 –
30 minutes for strip)? Why do bands appear if I leave
the test overnight?
A Bands appear due to lower levels of specific IgG or
cross-reactive antibody.
Commonly Asked Questions
about Panbio dengue tests...
Q How do I interpret faint lines in the Dengue Rapid
Tests?
A Any Sign of a line is a positive result.
Commonly Asked Questions
about Panbio dengue tests...
Q In the Panbio Dengue Duo ELISA and Dengue Rapid
Tests, why don’t symptomatic donors from endemic
areas show elevation of IgG?
A IgG Cutoff set above the level in Primary and Past
Dengue.
Commonly Asked Questions
about Panbio dengue tests...
Q How do the cutoffs of these tests compare with
haemagglutination-inhibition assays?
A IgG Cutoff = HAI Titre for 2° Dengue (e.g. HAI 1:2560).
Commonly Asked Questions
about Panbio dengue tests...
Q Do I need to use both IgM and IgG for the diagnosis of
dengue infection? Why can’t I just use IgM?
A Some cases of secondary dengue do not show
detectable IgM.
Panbio Dengue: The complete
range
ELISA kits
•
•
•
•
Dengue IgG Indirect
Dengue IgM Capture
Dengue IgG Capture
Dengue Duo Capture IgG & IgM
E-DEN01G
E-DEN01M
E-DEN02G
E-DEN01D
Rapid kits
• Dengue Rapid Strip test
• Dengue Rapid Cassette
R-DEN02D
R-DEN03D
Marketing material available
•
PB0074 Colour brochure
•
PB0070 Poster presented in India 2004
“New developments in flavivirus diagnostics”
Marketing material available cont.
• Publication
Garcia M. et al. (2005) Evaluation of a field test for the detection of
dengue antibodies. Arbovirus Research in Australia. 9:111-7.
• PB0081 Dengue Summary Card
(shows procedure, interpretation and reading guide) Limited quantities only
Please contact Amy Yorston to request copies of this material
amy_yorston@panbio.com
www.panbio.com