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).
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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 at multiple sites 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.
Sample-to-answer
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.
Intuitive 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 access software during run.
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
- 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
Load
In each Disc Wedge:
- Load 50 µL of sample
- Load 50 µL of reaction mix
- Close the foil and remove the tab
Run Samples
Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.
- Disc may be re-used up to 8 times (until all Wedges are utilized)
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.
Simplexa® Bordetella Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® Bordetella Direct |
24 |
IVD | MOL2750 |
|
Simplexa® Bordetella Direct Positive Control Pack |
10 |
IVD | MOL2760 |