Bordetella Direct Test

Great Basin is developing the Bordetella Direct Test which detects Bordetella pertussis directly from the patient specimen, identifying the bacterium behind the highly-contagious respiratory disease commonly known as whooping cough.

Need for Testing

The Centers for Disease Control and Prevention (CDC) estimates that globally there are approximately 16 million cases of pertussis per year, with the disease being responsible for 195,000 deaths annually. Reported cases of pertussis in the U.S. have spiked since 1955, likely a result of declines in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, and continued circulation of B. pertussis in the population. Given the gravity of the disease as well as its capacity for contagion, hospitals, health systems and patients can benefit from the rapid detection and timely treatment of pertussis.

Advantage of the Great Basin’s Bordetella Direct Assay over conventional culture methodology

The CDC states, PCR is an important tool for diagnosis of pertussis especially in the setting of the current resurgence of pertussis disease. PCR can provide timely results with improved sensitivity over culture.[1] Conventional laboratory based culture testing for pertussis have variable low sensitivity between 12 and 60%. Culture can take 7 to 10 days to report and negative result does not rule out pertussis infection.

The Great Basin System

Great Basin’s System employs an integrated disposable cartridge containing all necessary reagents, and a bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician.

  • True sample-to-result with less than 1 minute of hands-on time
  • On-demand testing; no batching of tests that delay results

Bordetella Direct Test sample-to-result assay

  • Detects pertussis
  • Less than 1-minute hands-on time
  • Fast differential diagnosis for better patient management
 [1] www.cdc.gov/pertussis/clinical/diagnostic-testing/diagnosis-confirmation.html

Product availability based on timing of FDA 510(k) clearance in US