自己採取呼吸器検体と臨床採取呼吸器検体の信頼性：自己採取精度およびベネフィット実装試験（S²wAB-IT）より

Routine surveillance cultures are critical in the care of patients with cystic fibrosis (CF) and are used in clinical decision-making. Due to the improved health of people with CF (pwCF) and the increased use of telehealth for clinical care, there is a strong interest in providing remote care, including remote respiratory specimen collection.

Are self-obtained respiratory samples (SOS) feasible and acceptable for persons with CF and are the results comparable to clinic-obtained samples (COS)?

Persons with CF, 1 year and older, were enrolled at 6 CF centers (4 pediatric, 2 adult). Two oropharyngeal samples were obtained (order randomized): one clinic-obtained sample (COS) per each CF center's practice and one self-obtained sample (SOS) following standardized education. The self-obtained sample was randomized to immediate versus delayed processing, for transport mimicry. Cohen's kappa was used to assess agreement between sample types. Surveys were completed to determine feasibility and acceptability.

164 pwCF were enrolled. Self-collection was feasible (99% successful SOS) and acceptable with 88% rating the collection as very easy or easy and 100% being willing to collect another sample if clinically recommended. The overall agreement between COS and SOS for any CF pathogen detection was 78.7% (Kappa 0.583, 95% CI: 0.432 - 0.734), suggesting moderate agreement. Agreement for Methicillin-susceptible Staphylococcus aureus (MSSA) detection was 87.9% (Kappa 0.748, 95% CI: 0.594 - 0.902), suggesting substantial agreement. Statistical analyses were not completed for other bacterial organisms due to low detection. Order of sample collection, time to processing, participant age, or collection by self or parent/guardian did not impact agreement.

Self-collection is feasible and acceptable for pwCF. Agreement between sample types suggest that self-collection may offer an alternate option for microbiology surveillance.