Simplexa™ Dengue Kit

A real-time RT-PCR assay for the in vitro detection and typing of dengue virus serotypes 1, 2, 3 and 4.

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KIT for Infectious Diseases

Overview

Background

Dengue fever is an acute, self limiting, viral disease that is characterized by fever, headache, body pains, rash, lymphadenopathy, and prostration. In its most severe form, dengue hemorrhagic fever, infected patients will experience severe fever and renal failure leading to the often fatal dengue shock syndrome.¹ It is estimated that approximately 2 billion people are at risk for dengue fever world wide, and as many as 100 million people per year are infected.^2,3 This, combined with the hundreds of thousands of cases of dengue shock syndrome, make dengue the most important arbovirus disease in the world.⁴

1. Halstead, SB. 1980. Immunological parameters of togavirus disease syndromes. p.107-173. In RW Schlesinger (ed.), The Toga Viruses. Academic Press, Inc., New York.
2. WHO, Dengue Guidelines for Diagnosis, Treatment, Prevention and Control, New edition (2009) WHO/HTM/NTD/DEN/2009.1.
3. CDC http://www.cdc.gov/dengue/epidemiology/index.html.
4. Halstead, SB. 1980. Immunological parameters of togavirus disease syndromes. p.107-173. In RW Schlesinger (ed.), The Toga Viruses. Academic Press, Inc., New York.

Why to choose it

A reliable and effective assay for detection and typing of dengue virus serotypes 1, 2, 3 and 4 from human serum.

For use on

LIAISON^® MDX

Universal Disc

Benefits

Reliability

Reliable performance that you can count on

>96% positive agreement

A panel of 179 samples with previously characterized dengue PCR results was obtained from the US Center of Disease Control and Prevention (CDC). The samples were tested in the Simplexa™ Dengue assay and compared to historical results as reported by the CDC and demonstrate >96% positive agreement for all serotypes.

Simplexa^TM Dengue Method Comparison

Dengue Virus 1 Comparison to Historical Results

	CDC Historical Results*	Simplexa^TM Dengue DV1: Detected	Simplexa^TM Dengue DV1: Non Detected	% Agreement (Observed/Expected) 95% CI
Detected	CDC Historical ResultsN: 32	Simplexa^TM Dengue DV1 Detected32	Simplexa^TM Dengue DV1 Non Detected0	% Agreement (Observed/Expected) 95% CIPPA: 100.0% (32/32) 95% CI: 89.3 to 100.0%
Non Detected	CDC Historical ResultsN: 147	Simplexa^TM Dengue DV1 Detected11^a	Simplexa^TM Dengue DV1 Non Detected136	% Agreement (Observed/Expected) 95% CINPA: 92.5% (136/147) 95% CI: 87.1 to 95.8%

Dengue Virus 2 Comparison to Historical Results

	CDC Historical Results*	Simplexa^TM Dengue DV1: Detected	Simplexa^TM Dengue DV1: Non Detected	% Agreement (Observed/Expected) 95% CI
Detected	CDC Historical ResultsN: 30	Simplexa^TM Dengue DV1 Detected29	Simplexa^TM Dengue DV1 Non Detected1^b	% Agreement (Observed/Expected) 95% CI96.7% (29/30) 95% CI: 83.3 to 99.4%
Non Detected	CDC Historical ResultsN: 149	Simplexa^TM Dengue DV1 Detected1^b	Simplexa^TM Dengue DV1 Non Detected148	% Agreement (Observed/Expected) 95% CI99.3% (148/149) 95% CI: 96.3 to 99.9%

Dengue Virus 3 Comparison to Historical Results

	CDC Historical Results*	Simplexa^TM Dengue DV1: Detected	Simplexa^TM Dengue DV1: Non Detected	% Agreement (Observed/Expected) 95% CI
Detected	CDC Historical ResultsN: 29	Simplexa^TM Dengue DV1 Detected29	Simplexa^TM Dengue DV1 Non Detected0	% Agreement (Observed/Expected) 95% CI100.0% (29/29) 95% CI: 88.3 to 100.0%
Non Detected	CDC Historical ResultsN: 150	Simplexa^TM Dengue DV1 Detected0	Simplexa^TM Dengue DV1 Non Detected150	% Agreement (Observed/Expected) 95% CI100.0% (150/150) 95% CI: 97.5 to 100.0%

Dengue Virus 4 Comparison to Historical Results

	CDC Historical Results*	Simplexa^TM Dengue DV1: Detected	Simplexa^TM Dengue DV1: Non Detected	% Agreement (Observed/Expected) 95% CI
Detected	CDC Historical ResultsN: 38	Simplexa^TM Dengue DV1 Detected37	Simplexa^TM Dengue DV1 Non Detected1^c	% Agreement (Observed/Expected) 95% CI97.4% (37/38) 95% CI: 86.5 to 99.5%
Non Detected	CDC Historical ResultsN: 141	Simplexa^TM Dengue DV1 Detected8^d	Simplexa^TM Dengue DV1 Non Detected133	% Agreement (Observed/Expected) 95% CI94.3% (133/141) 95% CI: 89.2 to 97.1%
* Samples were provided by Jeorge L. Munoz-Jordan, PhD, Chief, Molecular Diagnostics and Reasearch, Centers for Disease Control and Prevention, Dengue Branch. PPA = Positive Percent Agreement, NPA = Negative Percent Agreement ^a Upon repeating testing, 5 of 11 samples were detected by the Simplexa Dengue assay and by an in-house assay based on CDC publications. The remaining 6 were not detected by the assay based on CDC publications. ^b Results were unchanged upon repeat testing. ^c Results were unchanged upon repeat testing. ^dUpon repeated testing, 2 of 8 samples were detected as DV4 by the Simplexa Dengue assay and by an in-house assay based on CDC publications. One sample was detected as DV1 and one sample was detected as DV2 in both assays. The remaining two samples were not detected upon repeat testing in both assays.

Libraries

DiaSorin Molecular Menu

Ordering info

Product	Code	Reactions
Product Simplexa^™ Dengue Kit	Code MOL3100	Reactions 100