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美国 RSV 抗原和 PCR 检测的全国和地区季节性阈值建模。

National and regional modeling of distinct RSV seasonality thresholds for antigen and PCR testing in the United States.

机构信息

US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.

Department of Pathology & Laboratory Medicine, Medical University of South Carolina, Charleston, SC, USA.

出版信息

J Clin Virol. 2019 Nov;120:68-77. doi: 10.1016/j.jcv.2019.09.010. Epub 2019 Sep 20.

Abstract

BACKGROUND

PCR tests now outnumber antigen tests for the diagnosis of respiratory syncytial virus (RSV) infection in the US. Recent analyses have shown that the traditional 10% positivity threshold to define an RSV season by rapid antigen testing was inappropriate for real-time PCR testing, for which 3% positivity appeared more appropriate.

OBJECTIVE

To respectively model antigen (10%) and PCR (3%) positivity thresholds at national and regional levels using a large dataset of RSV testing results from US hospital-affiliated laboratories.

STUDY DESIGN

From 2011-2016, 599 laboratories participated in a national RSV surveillance program (RSVAlert®). For laboratories with ≥10 tests for ≥30 weeks of a season, national and regional test numbers and positivity were summarized by test type overall, by season, and weekly within each season. Test type positivity thresholds were used to calculate season onset and offset.

RESULTS

A seasonal average of 543,387 RSV tests was reported. PCR testing increased from 26% in 2011-2012 to 72% in 2015-2016. Overall, national positivity was 15.6% for antigen and 8.3% for PCR testing. National RSV season onsets and offsets were comparable using the 10% antigen and 3% PCR thresholds, but PCR-defined seasons generally started and ended later than antigen-defined seasons. Regionally, there were fewer outlier estimates of RSV season length when the predominant regional test type was used to define the season.

CONCLUSION

RSV positivity rates differed by test type, likely due to differential clinical use of the tests. These findings support the use of distinct positivity thresholds by test type.

摘要

背景

在美国,聚合酶链反应(PCR)检测现在已超过抗原检测,用于诊断呼吸道合胞病毒(RSV)感染。最近的分析表明,传统的通过快速抗原检测来定义 RSV 季节的 10%阳性阈值并不适用于实时 PCR 检测,后者的 3%阳性似乎更为合适。

目的

使用来自美国医院附属实验室的大量 RSV 检测结果数据集,分别为抗原(10%)和 PCR(3%)检测建立全国和地区水平的阳性阈值模型。

研究设计

2011 年至 2016 年,599 家实验室参与了一项全国性 RSV 监测计划(RSVAlert®)。对于每个季节检测 ≥30 周且至少有 10 次检测的实验室,按检测类型、季节和每周汇总全国和地区的检测数量和阳性率。使用检测类型阳性率阈值来计算季节开始和结束时间。

结果

报告了 543,387 次 RSV 季节性平均检测。PCR 检测从 2011-2012 年的 26%增加到 2015-2016 年的 72%。总体而言,抗原检测的全国阳性率为 15.6%,PCR 检测为 8.3%。使用 10%的抗原和 3%的 PCR 阈值,全国 RSV 季节的开始和结束时间相似,但 PCR 定义的季节通常比抗原定义的季节开始和结束时间晚。在以主要区域检测类型来定义季节的情况下,区域 RSV 季节长度的异常值估计较少。

结论

不同的检测类型会导致 RSV 阳性率的差异,这可能是由于这些检测的临床应用不同。这些发现支持根据检测类型使用不同的阳性阈值。

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