Skip to main content

Please select
your location below

Attenzione, le pagine di questa sezione sono disponibili solo in lingua inglese.

By selecting the International view, you verify that you reside outside of the USA and you wish to view DiaSorin Molecular’s International Product Information. This material is intended for International (non-USA) site visitors only.

Pursuant to the Guidelines of the Ministry of Health dated 28/03/2013 related to health advertising concerning medical devices, in vitro diagnostic medical devices and medical-surgical devices, we hereby inform you that the information contained in this website and to which you are going to access is exclusively intended for professionaloperators.

Simplexa® Bordetella Direct

Detect and differentiate Bordetella pertussis & Bordetella parapertussis

A real-time qualitative PCR assay enabling differential diagnosis of the major causative agents of pertussis (whooping cough).

Simplexa® Bordetella Direct

Disease state

Pertussis, commonly called ‘whooping cough’, is a highly contagious globally endemic respiratory disease caused by small gram-negative bacteria: Bordetella pertussis and Bordetella parapertussis. Clinically, it presents with a prolonged cough and patients infected through airborne droplets typically have episodes of violent cough that may be followed by an inspiratory whoop and vomiting.

Pertussis occurs in all ages. There were 24 million global pertussis cases and 160,700 deaths among children younger than age five years in 2014; CDC-Pertussis website. In the US, despite Pertussis' vaccinations, in 2009-2019 the average cases reported to CDC were 28,409 but sporadic outbreaks occur with 48,227 cases reported in 2012. Bordetella pertussis causes most cases but ~20% of cases are Bordetella parapertussis. Diagnostics is key to prevent outbreaks especially in young or immunocompromised individuals. 

Globally endemic disease

The value of Simplexa® Bordetella Direct

Faster diagnosis means better patient outcomes and prevents outbreaks!

Differential diagnosis

Accurate detection and differentiation of the B. pertussis IS481 and B. parapertussis IS1001 repeat elements.

Fast time-to-result

Easy to use sample-to-answer system with no DNA extraction and all-in-one reagents for use with nasopharyngeal swabs.

Confidence in your results

Clinical sensitivity (PPA) in multi-center evaluations was 91.9% / 100% for B. pertussis and B. parapertussis, respectively & specificity (NPA) was 97.9%/99.6%, respectively.

Less effort, faster results

Evaluations with seven different FDA-cleared NAATs showed Simplexa® Bordetella Direct had favorable performance, hands-on time, and fast assay time (60 mins).

How Simplexa® Bordetella Direct works

Simplexa® Bordetella Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted primary sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.



Scan 1-8 primary unextracted samples per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON MDX Instrument, and press run for results in 60 minutes.


Intiutive LIAISON® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays. View PCR curves and QC Charts, interface with LIS and even during run access software.

Indications for Simplexa® Bordetella Direct use

Assay and system

A real-time PCR assay run on LIAISON® MDX to detect Bordetella pertussis & Bordetella parapertussis in one sample

Patient types

Human patients with signs and symptoms of Bordetella infection of the respiratory tract

Diagnostic lab

Hospital,  Commercial, Reference

Simplexa® Bordetella Direct workflow

 Scan, load and go

Ready to use

  • No prep &  No waste
  • Single use reagents (24 reactions) 
  • No mixing, pouring or rehydrating

Simple & Easy workflow

  • No extraction needed, direct sample input
  • Liquid sensor to ensure adequate sample volume metered: No precise pipetting required
  • CLIA Moderate Complexity


  • Scan the assay definition QR code (upon first use only)
  • Scan the lot-specific QR code on a vial or card
  • Scan the disc barcode
  • Scan the sample barcode


In each Disc Wedge:

  • Load 50 µL of sample
  • Load 50 µL of reaction mix (= 1 vial content)
  • Close the foil and remove the tab
  • Disc may be re-used up to 8 times (until all Wedges are utilized)
  • Close the foil and remove the tab

Load and run

Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.

To be used on the LIAISON® MDX Instrument

The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.

Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.

Molecular Diagnostic Tool LIAISON® MDX - Diasorin


One instrument.
Multiple discs.
Ultimate Flexibility.

Discover more

Simplexa® Bordetella Direct ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa® Bordetella Direct




Simplexa® Bordetella  Direct Positive Control Pack





Diasorin document repository


Luminex document repository

Discover more

Research publications

Discover more

More details about Simplexa® Bordetella Direct

Get in touch

If you need any information about our products, contact our specialists. 

Contact us

Need any help?

Get help with Diasorin products and services.

Ask for support