Department of Family Medicine and Community Health, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, United States of America.
Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, United States of America.
PLoS One. 2022 May 10;17(5):e0268279. doi: 10.1371/journal.pone.0268279. eCollection 2022.
Seasonal influenza leads to an increase in outpatient clinic visits. Timely, accurate, and affordable testing could facilitate improved treatment outcomes. Rapid influenza diagnostic tests (RIDTs) provide results in as little as 15 minutes and are relatively inexpensive, but have reduced sensitivity when compared to RT-PCR. The contributions of multiple factors related to test performance are not well defined for ambulatory care settings. We assessed clinical and laboratory factors that may affect the sensitivity and specificity of Sofia Influenza A+B Fluorescence Immunoassay.
We performed a post-hoc assessment of surveillance data amassed over seven years from five primary care clinics. We analyzed 4,475 paired RIDT and RT-PCR results from specimens collected from patients presenting with respiratory symptoms and examined eleven potential factors with additional sub-categories that could affect RIDT sensitivity.
In an unadjusted analysis, greater sensitivity was associated with the presence of an influenza-like illness (ILI), no other virus detected, no seasonal influenza vaccination, younger age, lower cycle threshold value, fewer days since illness onset, nasal discharge, stuffy nose, and fever. After adjustment, presence of an ILI, younger age, fewer days from onset, no co-detection, and presence of a nasal discharge maintained significance.
Clinical and laboratory factors may affect RIDT sensitivity. Identifying potential factors during point-of-care testing could aid clinicians in appropriately interpreting negative influenza RIDT results.
季节性流感会导致门诊就诊量增加。及时、准确且经济实惠的检测方法有助于改善治疗效果。快速流感诊断检测（RIDT）可在 15 分钟内提供结果，且相对较为廉价，但与 RT-PCR 相比，其灵敏度较低。在门诊环境中，与检测性能相关的多种因素的影响尚不清楚。我们评估了可能影响 Sofia 流感 A+B 荧光免疫分析检测灵敏度和特异性的临床和实验室因素。
我们对来自五家初级保健诊所的七年来收集的监测数据进行了事后评估。我们分析了来自有呼吸道症状的患者的 4475 对 RIDT 和 RT-PCR 结果，并检查了可能影响 RIDT 灵敏度的十一个潜在因素及其附加子类别。
在未调整的分析中，RIDT 灵敏度更高与流感样疾病（ILI）存在、未检测到其他病毒、未接种季节性流感疫苗、年龄较小、较低的循环阈值、疾病发病后天数较短、鼻分泌物、鼻塞和发热有关。在调整后，ILI 存在、年龄较小、发病后天数较短、无共同检测到的病原体以及存在鼻分泌物仍然具有显著性。
临床和实验室因素可能会影响 RIDT 的灵敏度。在即时检测时识别潜在因素可能有助于临床医生正确解读阴性流感 RIDT 结果。
