INFECTIOUS DISEASE

Simplexa™ Bordetella Direct Kit

Simple and Reliable Bordetella TestingDirect detection and differentiation of Bordetella pertussis and Bordetella parapertussis

Bordetella

Since the late 1990s, there has been a marked increase in the number of reported pertussis cases in developed countries with high vaccination rates. The World Health Organization estimates that in 2008, there were 16 million whooping cough cases worldwide, 95% of which were in developing countries, resulting in 195,000 child fatalities1. A recent publication estimates that there were 24.1 million pertussis cases and 160,700 deaths in children younger than 5 years in 2014 worldwide2. A great majority of these cases is caused by Bordetella pertussis among all age groups (e.g. neonates, chilren, adolecents and adults); however, up to 20%, are caused by Bordetella parapertussis, a milder pertussis-like disease for which there is no vaccine currently available.

Direct PCR testing with our Simplexa™ Bordetella Direct assay provides a rapid and reliable differential detection and diagnosis of B. pertussis and B. parapertussis.

Simplexa™ Bordetella Direct Kit

Simple and Reliable Bordetella TestingA real-time PCR assay for the direct detection and differentiation of the Bordetella pertussis IS481 element and the Bordetella parapertussis IS1001 element.

Simple and Dependable Bordetella Testing

• Broad coverage for your testing needs: Detect both B. pertussis and B. parapertussis.

• Sample type: Nasopharyngeal swabs.

• Fast time-to-result: Results delivered in about an hour.

• Comprehensive respiratory testing: Our Simplexa™ assays ensure quality Flu A/B, RSV, Group A Strep, and Bordetella testing.

INFECTIOUS DISEASE

REFERENCES: 1. World Health Organization. www.who.int/immunization/topics/pertussis/en. 2. Yeung KHT, Duclos P, Anthony E, et al. An update of the global burden of pertussis in children younger than 5 years: A modelling study. Lancet. Epub ahead of print. 2017. 3. Linneman et. al., Am J Dis Child. 1977. 131:560-563. 4. Mertsola, J. Eur J Clin Microbiol. 1985. 4:123-128. 5. MOL2750, Simplexa™ Bordetella Direct Instructions for Use.

Proven performance that you can count onIn a thorough study of over 1400 prospective samples, our Simplexa™ Bordetella Direct assay showed a positive percent agreement of 98.9% and a negative percent agreement of 98.9% for Bordetella pertussis when compared to bi-directional sequencing and discrepant resolution on an FDA cleared nucleic acid amplification test (NAAT).

Simplexa™ Bordetella Direct Clinical Agreement Study5

POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

Bordetella pertussis 89.1% (90/101)* 95% CI: 81.5% to 93.8%

98.8% (1285/1300)*95% CI: 98.1% to 99.3%

Bordetella parapertussis

100% (71/71) 95% CI: 94.9% to 100.0%

99.7% (1329/1330) 95% CI: 99.2% to 100.0%

*After FDA cleared NAAT testing, the resolved Positive Percent Agreement resulted to 98.9% (91/92) with 95% CI of 94.1% to 100.0% and the resolved Negative Percent Agreement to 98.9% (1295/1309) with 95% CI of 98.2% to 99.4%.

Streamlined workflow

SCAN samples and reagents.

PIPETTE samples and reagents directly onto the disc.

LOAD and press RUN.

Simple and easy workflow enabling the assay to be run on any shift and bypass conventional DNA extraction procedures.

Your solution for Bordetella testing

Ordering information – Simplexa™ Bordetella Direct

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2750 Simplexa™ Bordetella Direct Kit* 24

MOL2760 Simplexa™ Bordetella Positive Control Pack 10 *To be used with Direct Amplification Discs (3 discs, MOL1455).

p: +1 (562) 240-6500 e: cs.molecular@diasorin.com w: www.molecular.diasorin.com

Cypress, CA USA

Simplexa and the associated logo are all trademarks or registered trademarks of DiaSorin Molecular LLC in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved.

The use of Scorpions™ probes for human in vitro diagnostic purposes is covered by a license to DiaSorin Molecular LLC from QIAGEN Manchester, UK. Scorpions is a registered trademark of QIAGEN Manchester, UK.

Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes.

Product availability subject to required regulatory approvals.

FOR OUTSIDE THE US AND/OR CANADA ONLY

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Ordering information - Simplexa™ Bordetella Universal Direct

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2700MOL2775

Simplexa™ Bordetella Universal Direct Kit

1001000

Other Simplexa™ Respiratory Products

Ordering information – Simplexa™ Direct Kits

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2650 Simplexa™ Flu A/B & RSV Direct Kit* 24

MOL2850 Simplexa™ Group A Strep Direct Kit* 24 *To be used with Direct Amplification Discs (3 discs, MOL1455).

Ordering information – Simplexa™ Kits

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2600 Simplexa™ Flu A/B & RSV Kit 100

MOL2500 Simplexa™ Influenza A H1N1 (2009) 100