SimplexaTM DengueKit

SimplexaTM 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.

Benefits

SimplexaTM DengueKit
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.

SimplexaTM Dengue Method Comparison
Dengue Virus 1 Comparison to Historical Results
CDC Historical Results* SimplexaTM Dengue DV1: Detected SimplexaTM Dengue DV1: Non Detected % Agreement
(Observed/Expected)
95% CI
Detected CDC Historical ResultsN: 32 SimplexaTM Dengue DV1 Detected32 SimplexaTM Dengue DV1 Non Detected0 % Agreement (Observed/Expected)
95% CI
PPA: 100.0% (32/32)
95% CI: 89.3 to 100.0%
Non Detected CDC Historical ResultsN: 147 SimplexaTM Dengue DV1 Detected11a SimplexaTM Dengue DV1 Non Detected136 % Agreement (Observed/Expected)
95% CI
NPA: 92.5% (136/147)
95% CI: 87.1 to 95.8%
Dengue Virus 2 Comparison to Historical Results
CDC Historical Results* SimplexaTM Dengue DV1: Detected SimplexaTM Dengue DV1: Non Detected % Agreement
(Observed/Expected)
95% CI
Detected CDC Historical ResultsN: 30 SimplexaTM Dengue DV1 Detected29 SimplexaTM Dengue DV1 Non Detected1b % Agreement (Observed/Expected)
95% CI
96.7% (29/30)
95% CI: 83.3 to 99.4%
Non Detected CDC Historical ResultsN: 149 SimplexaTM Dengue DV1 Detected1b SimplexaTM Dengue DV1 Non Detected148 % Agreement (Observed/Expected)
95% CI
99.3% (148/149)
95% CI: 96.3 to 99.9%
Dengue Virus 3 Comparison to Historical Results
CDC Historical Results* SimplexaTM Dengue DV1: Detected SimplexaTM Dengue DV1: Non Detected % Agreement
(Observed/Expected)
95% CI
Detected CDC Historical ResultsN: 29 SimplexaTM Dengue DV1 Detected29 SimplexaTM Dengue DV1 Non Detected0 % Agreement (Observed/Expected)
95% CI
100.0% (29/29)
95% CI: 88.3 to 100.0%
Non Detected CDC Historical ResultsN: 150 SimplexaTM Dengue DV1 Detected0 SimplexaTM Dengue DV1 Non Detected150 % Agreement (Observed/Expected)
95% CI
100.0% (150/150)
95% CI: 97.5 to 100.0%
Dengue Virus 4 Comparison to Historical Results
CDC Historical Results* SimplexaTM Dengue DV1: Detected SimplexaTM Dengue DV1: Non Detected % Agreement
(Observed/Expected)
95% CI
Detected CDC Historical ResultsN: 38 SimplexaTM Dengue DV1 Detected37 SimplexaTM Dengue DV1 Non Detected1c % Agreement (Observed/Expected)
95% CI
97.4% (37/38)
95% CI: 86.5 to 99.5%
Non Detected CDC Historical ResultsN: 141 SimplexaTM Dengue DV1 Detected8d SimplexaTM Dengue DV1 Non Detected133 % Agreement (Observed/Expected)
95% CI
94.3% (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.

Ordering info

Product Code Reactions
Product

Simplexa Dengue Kit

Code MOL3100 Reactions 100

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