Bordetella panel

Bordetella panel
A mother holds her crying baby, who is being examined by a doctor using a stethoscope

Rapid, accurate diagnostic solutions. Bordetella detection made easy.

Pertussis (whooping cough) cases have risen in recent years, yet current Bordetella tests are primarily intended for laboratory use. There is a critical need for Point of Care molecular diagnostic tests that can quickly and accurately identify Bordetella species, including B. pertussis, in near-patient settings, such as primary care clinics. This is essential to ensure timely, effective patient care and disease control.

The global pertussis testing gap

A world map of diverse human figures representing the number of patients with pertussis-like symptoms who should be tested

How many patients should be tested for pertussis?

~75.5 M patients worldwide who present with pertussis-like symptoms should be tested each year1

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A global map made of numerous diverse human figures representing the 8 million people actually tested for pertussis

How many patients are tested?

But only ~8.3 M actually get tested1

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A handful of diverse figures represent the few accurate pertussis tests performed annually

How many patients are tested using gold-standard PCR?

And of those, only ~1 M PCR-accurate pertussis tests are performed each year1

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Benefits at a glance

Benefits at a glance

Related categories

cobas® liat Bordetella panel clinical performance2

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cobas® liat Bordetella panel clinical performance2

 

PPA (95% CI)

NPA (95% CI)

LoD* (CFU/mL)

B. pertussis

97.8% (93.7–99.2)

99.9% (99.4–100.0)

36–43

B. parapertussis

98.6% (94.9–99.6)

99.8% (99.2–99.9)

32–36 

B. holmesii 

100.0% (97.3–100.0)

99.7% (99.0–99.9)

21–34
PPA = Positive Percent Agreement, NPA = Negative Percent Agreement, CI = Confidence Interval, LoD = Limit of Detection
*Strain references: B. pertussis: A639 & E431; B. parapertussis: E838 & A747; B. holmesii: F061 & 51541

cobas® liat Bordetella panel test specifications

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cobas® liat Bordetella panel test specifications

Instrument

cobas® liat analyser

Targets

B. pertussis
B. parapertussis

B. holmesii

Registration

CE-IVD, included on the ARTG, FDA 510(k) approved and CLIA waived

Sample type

Nasopharyngeal (NPS)

Collection media

UTM, VTM, and Liquid Amies

Sample extraction

Fully automated and integrated

Technology

Real-time PCR

Control

Internal sample processing control, positive and negative controls

Time to result

~15 minutes

Reagents

Ready-to-use,
pre-packed tube format

Kit storage

2–8°C

Overview

 

Country: Rest of the world

The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated multiplex real-time polymerase chain reaction (PCR) assay for the rapid in vitro qualitative detection and differentiation of B. pertussis, B. parapertussis, and B. holmesii DNA in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

Negative results do not preclude B. pertussis, B. parapertussis, or B. holmesii infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

The cobas® liat Bordetella panel is intended for professional use in a clinical laboratory setting, near-patient testing, or point-of-care (POC) location in conjunction with clinical and epidemiological risk factors.

Country: US

The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

Ordering information

 

 Material number                                        Material description
 09857664190  KIT COBAS LIAT BORDETELLA PANEL IVD            

 

Technical Documents

 

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