Near Patient Microbial Testing in Cystic Fibrosis

• To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group.
• Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or more biomarkers required to achieve an accuracy of greater than 95%?
• Can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? What is the business case for healthcare providers to adopt our future test for home use? We estimate a 50% saving. Can this be confirmed?
• When used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? What is the business case for adopting our future test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the new revolutionary tool that we anticipate?
• We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease severity bands 2-A to 5. Can we provide evidence for this to support further investment?

Inclusion criteria

• Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels.
• Chronic infection with Pseudomonas aeruginosa.
• Patients able to produce daily sputum samples.
• Current history of at least two pulmonary infective exacerbations in the past 12 months.
• Able to give written informed consent

Exclusion criteria

• Unable to provide written informed consent
• Patients unable to produce daily sputum samples
• Fewer than two infective pulmonary exacerbations in 12 months