Reliability of Clinic-Obtained vs Self-Obtained Respiratory Samples From the Self-Sample Accuracy and Benefit Implementation Trial (S2wAB-IT).

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.

由于囊性纤维化患者（pwCF）的健康状况改善以及远程医疗在临床护理中的使用增加，因此提供远程护理，包括远程呼吸道样本采集，引起了强烈的兴趣。

research_question

Are self-obtained respiratory samples feasible and acceptable for pwCF and are the results comparable with clinic-obtained samples (COSs)?

自我采集的呼吸样本对于囊性纤维化患者是否可行且可接受，其结果是否与临床采集样本（COSs）相当？

study_design_and_methods

pwCF ≥ 1 year of age were enrolled at 6 CF centers (4 pediatric and 2 adult).

年龄≥1岁的囊性纤维化患者在6个囊性纤维化中心（4个儿科和2个成人）进行了登记。

Two oropharyngeal samples were obtained (order randomized): 1 COS per each CF center's practice and 1 self-obtained sample (SOS) after standardized education.

获取了两份口咽样本（顺序随机化）：每家囊性纤维化（CF）中心的实践获取1份临床操作样本（COS），以及在标准化教育后获取1份自我采集样本（SOS）

The SOS was randomized to immediate vs delayed processing, for transport mimicry.

SOS被随机分为立即处理组与延迟处理组，以模拟运输过程。

Cohen kappa was used to assess agreement between sample types.

使用Cohen kappa评估样本类型之间的一致性。

Surveys were completed to determine feasibility and acceptability.

完成调查以确定可行性和可接受性。

Results

A total of 164 pwCF were enrolled.

共有164名pwCF患者被纳入研究。

Self-collection was feasible (99% successful SOSs) and acceptable with 88% rating the collection as very easy or easy and 100% being willing to collect another sample if clinically recommended.

自我采样是可行的（99%的成功率），并且可接受，其中88%的受试者认为采样非常容易或容易，并且100%的受试者愿意在临床推荐的情况下再次收集样本。

The overall agreement between COSs and SOSs for any CF pathogen detection was 78.7% (kappa, 0.583; 95% CI, 0.432-0.734), suggesting moderate agreement.

COSs和SOSs在检测任何CF病原体时的一致性为78.7%（kappa值，0.583；95%置信区间，0.432-0.734），表明中度一致性。

Agreement for methicillin-susceptible Staphylococcus aureus detection was 87.9% (kappa, 0.748; 95% CI, 0.594-0.902), suggesting substantial agreement.

对甲氧西林敏感金黄色葡萄球菌检测的一致性为87.9%（kappa值，0.748；95%置信区间，0.594-0.902），表明有相当大的一致性。

Statistical analyses were not completed for other bacterial organisms due to low detection.

由于检出率低，其他细菌的统计分析尚未完成。

Order of sample collection, time to processing, participant age, or collection by self or parent/guardian did not impact agreement.

样本采集的顺序、处理时间、参与者年龄，或是由自己或父母/监护人采集，并未影响一致性。

interpretation

Our results indicate that self-collection is feasible and acceptable for pwCF.

我们的结果表明，自我采样对于囊性纤维化患者是可行且可接受的。

Agreement between sample types suggest that self-collection may offer an alternate option for microbiology surveillance.

样本类型之间的一致性表明，自我采样可能为微生物学监测提供了一个替代方案。