Source
Study design (if review, criteria of inclusion for studies)
Multicentre cohort study
Participants
96 patients with CF without chronic . P. aeruginosa colonization.
Interventions
P. aeruginosa quantitative PCR (qPCR). Sputum samples were collected at each visit. Conventional culture and two-step qPCR (oprL qPCR and . gyrB. /ecfX qPCR) were performed for 707 samples. The positivity criteria were based on the qPCR results, defined in a previous study as follow: . oprL qPCR positivity alone if bacterial density was <730 CFU/mL or . oprL qPCR combined with . gyrB. /ecfX qPCR if bacterial density was >730 CFU/mL.
Outcome measures
P. aeruginosa qPCR sensitivity and specificity, and the possible time saved by qPCR in comparison with standard practice (culture).
Main results
During follow up, 36 of the 96 patients with CF were diagnosed on culture as colonized with . P. aeruginosa. This two-step qPCR displayed a sensitivity of 94.3% (95% CI 79.7%-98.6%), and a specificity of 86.3% (95% CI 83.4%-88.7%). It enabled . P. aeruginosa acquisition to be diagnosed earlier in 20 patients, providing a median detection time gain of 8 months (interquartile range 3.7-17.6) for them.
Authors' conclusions
Implementing . oprL and . gyrB. /ecfX qPCR in the management of patients with CF allowed earlier detection of first . P. aeruginosa lung positivity than culture alone.