Simplexa Bordetella Direct Kit Simple and Reliable ... · Pertussis, commonly called whooping...
Transcript of Simplexa Bordetella Direct Kit Simple and Reliable ... · Pertussis, commonly called whooping...
Simplexa® Bordetella Direct Kit
Simple and ReliableBordetella TestingDirect 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 TestingA 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 onIn 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. pertussisprospective 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. pertussisprospective 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. parapertussisprospective 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. parapertussisprospective 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.
USB
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Product availability subject to required regulatory approvals.
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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.