DiaSorin Molecular Simplexa® Flu A/B & RSV Direct Kit

Simplexa™ Flu A/B & RSV Kit

Reliable detection and differentiation of influenza A virus, influenza B virus and RSV

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KIT for Infectious Diseases

Overview

Background

The CDC estimates that influenza has resulted in up to 35.6 million illnesses, 710,000 hospitalizations, and as many as 56,000 deaths annually since 2010.¹

Respiratory syncytial virus (RSV) infection is more prevalent in infants and toddlers and is a leading cause of hospitalization in this age group, but RSV also causes disease in adults that can be severe in certain populations.²

1. https://www.cdc.gov/flu/about/disease/burden.htm
2. MOL2650, Simplexa^TM Flu A/B & RSV Direct Kit Product Insert, Rev. F.

Why to choose it

Capable of running 94 patient samples at the same time.

For use on

LIAISON^® MDX

Universal Disc

Benefits

Detect
92 strains

DiaSorin Molecular is committed to ongoing monitoring and testing of emerging flu strains to ensure the most comprehensive strain coverage

92 strains have been validated, with more strains tested regularly to provide confidence in your results.

CURRENT STRAIN MONITORING

2016/2017 VACCINE STRAINS
2016/2017 vaccine strains A/California/7/2009 (H1N1)-like virus^V
A/Hong Kong/4801/2014 (H3N2)-like virus ^T
B/Brisbane/60/2008-like virus^V
B/Phuket/3073/2013-like virus ^V*

2017/2018 VACCINE STRAINS
2017/2018 vaccine strains A/Michigan/45/2015 (H1N1)pdm09-like virus^R
A/Hong Kong/4801/2014 (H3N2)-like virus ^T
B/Brisbane/60/2008-like virus^V
B/Phuket/3073/2013-like virus ^V*

V = Validated and in FDA cleared PI
T = Tested but not submitted to FDA to revise PI
R = Recently ordered from IRR, will be tested
* in quadrivalent vaccine

Reliability

Reliable performance that you can count on

greater than 98% specificity

Simplexa^TM Flu A/B & RSV assay has 100% sensitivity and greater than 98% specificity.

Simplexa^TM Flu A/B and Culture/DFA Clinical Agreement

Influenza A

Clinical Agreement	Prospective Samples	Retrospective Samples
Clinical Agreement Sensitivity	Prospective Samples 100%	Retrospective Samples 100%
Clinical Agreement Specificity	Prospective Samples 99.3%	Retrospective Samples 100%

Influenza B

Clinical Agreement	Prospective Samples	Retrospective Samples
Clinical Agreement Sensitivity	Prospective Samples 100%	Retrospective Samples 100%
Clinical Agreement Specificity	Prospective Samples 99.8%	Retrospective Samples 100%

RSV

Clinical Agreement	Prospective Samples	Retrospective Samples
Clinical Agreement Sensitivity	Prospective Samples 98.0%	Retrospective Samples 100%
Clinical Agreement Specificity	Prospective Samples 96.9%	Retrospective Samples 96.0%