Simplexa Bordetella Direct Kit

Simplexa Bordetella Direct Kit

Background

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. The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths. 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, up to 20% of cases are caused by Bordetella parapertussis, which can present clinically as a milder pertussis-like disease.

Why to choose it

A CLIA moderate complexity assay with broad coverage, including both B. pertussis and B. parapertussis, for your testing needs. The assay improves efficiency with a true sample-to-answer workflow without DNA extraction.

Benefits

Simple and Dependable Bordetella Testing 

The Simplexa Bordetella Direct assay provides results in about an hour direct from nasopharyngeal swabs without the need for DNA isolation.

Reliability

Reliable performance that you can count on

In a thorough study of over 1400 samples, our Simplexa Bordetella Direct assay showed a positive percent agreement of 98.9% and a negative percent agreement of 98.8% for Bordetella pertussis when compared to bi-directional sequencing with discrepant resolution on an FDA cleared nucleic acid amplification test (NAAT).

For use on

LIAISON MDX

DIRECT AMPLIFICATION DISC

SIMPLEXA BORDETELLA DIRECT CLINICAL AGREEMENT STUDY

Positive % Agreement 

Negative % Agreement 

Bordetella pertussis 

prospective samples 

89.1% (90/101)*

95% Cl: 81.5% to 93.8%

98.8% (1179/1188)*

95% Cl: 97.9% to 99.3%

Bordetella parapertussis

prospective samples

100% (15/15)

95% Cl: 78.2% to 100.0%

99.7% (1270/1274)

95% Cl: 99.2% to 99.9%

Bordetella parapertussis

contrived samples

100% (56/56) 

95% Cl: 93.6% to 100.0%

99.7% (56/56)

95% Cl: 93.6% to 100.0%

Ordering Info

PRODUCTCODEQUANTITY

LIAISON MDX

INCLUDES: 220V laptop computer, accessories box, and optional printer

MOL1011
CE FDA

1

LIAISON MDX

INCLUDES: 110V laptop computer, accessories box, and optional printer

MOL1001
CE FDA

1

Accessories Box

INCLUDES: Ethernet Cable (MOL1102), Bar Code Scanner (MOL1103), Mouse Pad (MOL1104),2X Universal Disc Loading Block (MOL1105), 2X Disc Film Applicator (MOL1106),Laptop Security Cable (MOL1109) UK power cord for LIAISON® MDX (MOL1012),UK power cord for Del Laptop (MOL1201), EU power cord for Dell laptop (MOL1202)

MOL1001
CE FDA

1

Simplexa Universal Disc (UD) Case

MOL1400

100

Simplexa Universal Disc (UD) Box

MOL1401 

25

Universal Disc (UD) Cover Tape

MOL1500

250

Direct Amplification Discs (DAD)

MOL1451 

24

Please click below for more information

SIMPLEXA BROCHURE




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