Panbio Dengue Duo Cassette

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!

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)

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

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.

“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.

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

The interpretation is the same as for the strip test

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

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 Basically highlight the high sensitivity in primary and secondary dengue together with the excellent specificity.

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) Highlight the high specificity of 91% when cross reactivity samples were tested.

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

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 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

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

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