panbio dengue duo cassette. name: dengue duo cassette cat. no. r-den03d expiry: 15 months storage: 2...
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Panbio Dengue Duo Cassette
Name: Dengue Duo Cassette
Cat. No. R-DEN03D
Expiry: 15 months
Storage: 2 – 30°C (room temperature, below 30°C)
Antigen: Recombinant Dengue 1 - 4
Sample: Plasma, serum or whole blood
Test time: 15 minutes
Kit size: 25 tests & MicroSafe tubes, 1 bottle of buffer
Procedure: 2 well cassette, 10uL serum, 2 drops of buffer
Product now available!
Product specifications
Features• The Dengue Duo Cassette has a number of benefits
over the current Dengue Strip Test.– 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 – 30C)
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, plasma or whole blood
Serum only
Additional requirements All components supplied Test tube required
Expiry 15 months 12 months
Storage 2 - 30C 2 - 8C
Performance Overall more sensitive for dengue than strip.
Good sensitivity and specificity.
Customer Laboratory & clinician Laboratory
Cassette v strip
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
• 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.
“No. 1 for fast dengue diagnosis anywhere, anytime.”
ProcedureClick 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
The interpretation is the same as for the strip test
Interpretation
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
• 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)
Study overview
Results
SITE 1: Malaysia evaluation
SITE 1: Malaysia evaluation
• 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.
Conclusion
SITE 2: Sri Lanka
• 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.
Study overview
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.
• Panbio Dengue Duo Cassette now available• Highly sensitive and specific• Offers considerable benefits over the current strip test
Summary
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.
ELISA kits• Dengue IgG Indirect E-DEN01G• Dengue IgM Capture E-DEN01M• Dengue IgG Capture E-DEN02G • Dengue Duo Capture IgG & IgM E-DEN01D
Rapid kits• Dengue Rapid Strip test R-DEN02D• Dengue Rapid Cassette R-DEN03D
Panbio Dengue: The complete range
• PB0074 Colour brochure
• PB0070 Poster presented in India 2004
“New developments in flavivirus diagnostics”
Marketing material available
Marketing material available cont.
• PB0081 Dengue Summary Card (shows procedure, interpretation and reading guide) Limited quantities only
Please contact Amy Yorston to request copies of this material
• PublicationGarcia M. et al. (2005) Evaluation of a field test for the detection of dengue antibodies. Arbovirus Research in Australia. 9:111-7.
www.panbio.com