1. Panbio Dengue Duo Cassette

2. Product specifications
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!

3. 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 – 30C)

4. Cassette v strip Format Cassette Strip IgM, IgG & Control line
Procedure
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 - 30C
2 - 8C
Performance
Overall more sensitive for dengue than strip.
Good sensitivity and specificity.
Customer
Laboratory & clinician
Laboratory

5. 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.

6. “No. 1 for fast dengue diagnosis anywhere, anytime.”
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.

7. Procedure
Click here to view as flash movie

8. 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

9. The interpretation is the same as for the strip test

10. Evaluation sites SITE 1 SITE 2
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

11. 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)

12. SITE 1: Malaysia evaluation
Results
Basically highlight the high sensitivity in primary and secondary dengue together with the excellent specificity.

13. 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.

14. 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.

15. SITE 2: Specificity (non-dengue sera)
Highlight the high specificity of 91% when cross reactivity samples were tested.

16. SITE 2: Sensitivity & specificity
with serum from hospital settings
Focus on the high sensitivity and specificity again.

17. 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.

18. Summary Panbio Dengue Duo Cassette now available
Highly sensitive and specific
Offers considerable benefits over the current strip test

19. 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.

20. 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.

21. 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.

22. 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).

23. 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.

24. Panbio Dengue: The complete range
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

25. Marketing material available
PB0074 Colour brochure
PB0070 Poster presented in India 2004
“New developments in flavivirus diagnostics”

26. 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