Simplexa® Bordetella Direct Kit

Simple and Reliable Bordetella Testing Direct detection and differentiation of Bordetella pertussis and Bordetella parapertussis

INFECTIOUS DISEASE

The quality of treatment starts with diagnosis.

Pertussis, commonly called whooping cough, is a highly contagious disease of the respiratory system caused by small gram negative bacteria; Bordetella pertussis and Bordetella parapertussis. Clinically, it presents with a prolonged cough and patients with classic disease often have episodes of violent cough that may be followed by an inspiratory whoop and vomiting. In severe cases, seen most commonly in young infants, these symptoms can lead to hypoxia, permanent brain damage, or death. In older children and adults, particularly those who have been vaccinated or previously had the disease, the illness can be milder and present as a prolonged cough.

Since the late 1990s, there has been a marked increase in the number of reported pertussis cases in developed countries with high vaccination rates. In 2012, 48,227 cases were reported in the United States, the highest number of reported cases since 1955.1 The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.2,3 Pertussis can be detected among all age groups (e.g., neonates, children, adolescents and adults). A great majority of these cases are caused by Bordetella pertussis; however, 2-20% of cases are caused by Bordetella parapertussis, which can present clinically as a milder pertussis-like disease.4

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

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.

Simplexa® Bordetella Direct Kit

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

INFECTIOUS DISEASE

REFERENCES: 1. Centers for Disease Control Data. Available at: https://www.cdc.gov/pertussis/outbreaks/trends.html 2. Kerr et al. Eur J Clin Microbiol Infect Dis. 2000. 19:77-88 3. Loeffelholz, M.J. J. Clin Microbiol. 2012. 50:2186-2190 4. Leber, A.L. Clin Lab Med. 2014. 34:237-255. 5. MOL2750, Simplexa® Bordetella Direct instructions for use.

Proven performance that you can count on In a thorough study of over 1300 samples, our Simplexa® Bordetella Direct assay showed a positive percent agreement greater than 91% and a negative percent agreement greater than 97% for both Bordetella pertussis and Bordetella parapertussis.

Simplexa® Bordetella Direct Clinical Agreement Study5

POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

B. pertussis prospective fresh samples

100.0% (36/36) 95% CI: 90.4% to 100.0%

97.9% (326/333) 95% CI: 95.7% to 99.0%

B. pertussis prospective frozen samples

91.9% (68/74) 95% CI: 83.4% to 96.2%

98.7% (1026/1039) 95% CI: 97.9% to 99.3%

B. parapertussis prospective fresh samples

100.0% (2/2) 95% CI: 34.2% to 100.0%

100.0% (174/174) 95% CI: 97.8% to 100.0%

B. parapertussis prospective frozen samples

100.0% (13/13) 95% CI: 77.2% to 100.0%

99.6% (1096/1100) 95% CI: 99.1% to 99.9%

B. parapertussis contrived frozen samples

100.0% (56/56) 95% CI: 93.6% to 100.0%

100.0% (56/56) 95% CI: 93.6% to 100.0%

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

Streamlined, simple workflow

SCAN samples and reagents.

PIPETTE samples and reagents directly onto the disc.

LOAD and press RUN.

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PB R1

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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.

Contact DiaSorin Molecular today! Call +1 (562) 240-6500 or visit: www.molecular.diasorin.com

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 *Direct Amplification Discs included in kit.

Ordering information – Simplexa® Kits

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2600 Simplexa® Flu A/B & RSV Kit 100

MOL2500 Simplexa® Influenza A H1N1 (2009) 100

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 *Direct Amplification Discs included in kit.