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

SimplexaTM Flu A/B & RSV Direct Kit

Simple direct detection and differentiation of influenza A virus, influenza B virus and RSV

Want to know more?

Get in touch
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, SimplexaTM Flu A/B & RSV Direct Kit Product Insert, Rev. F.

Why to choose it

A CLIA moderate complexity assay with the most comprehensive strain coverage (92 strains) that ensures high performance and provides improved efficiency with a true sample-to-answer workflow without RNA extraction.

Benefits

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

DiaSorin Molecular continually monitors the major flu databases and tests newly emerging and vaccine flu strains on an ongoing basis.

92 strains

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 virusV
A/Hong Kong/4801/2014
(H3N2)-like virus T
B/Brisbane/60/2008-like virusV
B/Phuket/3073/2013-like virus V*
2017/2018 VACCINE STRAINS
2017/2018
vaccine strains
A/Michigan/45/2015
(H1N1)pdm09-like virusR
A/Hong Kong/4801/2014
(H3N2)-like virus T
B/Brisbane/60/2008-like virusV
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 97% sensitivity

SimplexaTM Flu A/B & RSV Direct assay has greater than 97% sensitivity.

SimplexaTM Flu A/B & RSV Direct Clinical Agreement Summary
Specimen Sensitivity Specificity
SpecimenInfluenza A Sensitivity97% (66/68)
95% CI:89.9 to 99.2%
Specificity97.9% (639/653)
95% CI:96.4 to 98.7%
SpecimenInfluenza B Sensitivity100% (21/21)
95% CI:84.5 to 100%
Specificity99.9% (697/698)
95% CI:99.2 to 100%
SpecimenRSV2 Sensitivity97.6% (82/84)
95% CI:91.7 to 99.3%
Specificity92.9% (592/637)
95% CI:90.7 to 94.7%
1MOL2650, SimplexaTM Flu A/B & RSV Direct Kit, Package Insert Rev. F.
2Mean values for these sites, but the three sites may not be statistically potable. Specificity at the three site ranged from 84.6% to 98.2%; Sensitivity ranged from 90.0% to 100%. See package insert for details. Sites used different culture methods for comparison, but the FDA-cleared NAAT used in the discrepancy analysis was the same at all three sites.


Ordering info

Product Code Reactions
Product

SimplexaTM Flu A/B & RSV Direct

 

* Direct Amplification Discs included in kit

Code MOL2650 Reactions 24
Product

SimplexaTM FLU A/B & RSV Direct Positive
Control Pack**

 

** Contains Inactivated influenza A virus, Inactivated influenza B virus, InactivatedContains inactivated influenza A virus, inactivated influenza B virus, and inactivated RSV.

Code MOL2660 Reactions 10 x 100 μL

Do you want to place an order or request a trial?

Discover more

Our repository

All the answers you need.
Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.

Access our repository