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侧向流动试验在儿童中对 SARS-CoV-2 的检测性能:使用前鼻和颊拭子的敏感性、特异性、阴性和阳性预测值。

Lateral flow test performance in children for SARS-CoV-2 using anterior nasal and buccal swabbing: sensitivity, specificity, negative and positive predictive values.

机构信息

Paediatric Surgery, Alder Hey Children's NHS Foundation Trust, Liverpool, UK

Cellular and Molecular Physiology, University of Liverpool, Liverpool, UK.

出版信息

Arch Dis Child. 2023 Feb;108(2):137-140. doi: 10.1136/archdischild-2022-324353. Epub 2022 Sep 9.

DOI:10.1136/archdischild-2022-324353
PMID:36657801
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9887373/
Abstract

OBJECTIVE

To determine if the sensitivity of the lateral flow test is dependent on the viral load and on the location of swabbing in the respiratory tract in children.

DESIGN

Phase 1: Routinely performed reverse transcriptase PCR (RT-PCR) using nose and throat (NT) swabs or endotracheal (ET) aspirates were compared with Innova lateral flow tests (LFTs) using anterior nasal (AN) swabs. Phase 2: RT-PCR-positive children underwent paired AN RT-PCR and LFT and/or paired AN RT-PCR and buccal LFT.

SETTING

Tertiary paediatric hospitals.

PATIENTS

Children under the age of 18 years. Phase 1: undergoing routine testing, phase 2: known SARS-CoV-2 positive.

RESULTS

Phase 1: 435 paired swabs taken in 431 asymptomatic patients resulted in 8 positive RT-PCRs, 9 PCR test failures and 418 negative RT-PCRs from NT or ET swabs. The test performance of AN LFT demonstrated sensitivity: 25% (4%-59%), specificity: 100% (99%-100%), positive predictive value (PPV): 100% (18%-100%) and negative predictive value (NPV): 99% (97%-99%).Phase 2: 14 AN RT-PCR-positive results demonstrated a sensitivity of 77% (50%-92%) of LFTs performed on AN swabs. 15/16 paired buccal LFT swabs were negative.

CONCLUSION

The NPV, PPV and specificity of LFTs are excellent. The sensitivity of LFTs compared with RT-PCR is good when the samples are colocated but may be reduced when the LFT swab is taken from the AN. Buccal swabs are not appropriate for LFT testing. Careful consideration of the swabbing reason, the tolerance of the child and the requirements for test processing (eg, rapidity of results) should be undertaken within hospital settings.

TRIAL REGISTRATION NUMBER

NCT04629157.

摘要

目的

确定侧向流动检测的敏感性是否依赖于病毒载量以及在呼吸道中拭子取样的位置,对象为儿童。

设计

第 1 阶段:比较常规进行的逆转录聚合酶链反应(RT-PCR),使用鼻和咽喉(NT)拭子或气管内(ET)抽吸物,与 Innova 侧向流动检测(LFT),使用前鼻(AN)拭子。第 2 阶段:对 RT-PCR 阳性的儿童进行 AN RT-PCR 和 LFT 配对,或 AN RT-PCR 和口腔 LFT 配对。

地点

三级儿科医院。

患者

年龄在 18 岁以下的儿童。第 1 阶段:进行常规检测,第 2 阶段:已知 SARS-CoV-2 阳性。

结果

第 1 阶段:在 431 名无症状患者中采集了 435 对拭子,结果显示 8 例 RT-PCR 阳性,9 例 PCR 检测失败,418 例 NT 或 ET 拭子 RT-PCR 阴性。AN LFT 的检测性能显示敏感性:25%(4%-59%),特异性:100%(99%-100%),阳性预测值(PPV):100%(18%-100%),阴性预测值(NPV):99%(97%-99%)。第 2 阶段:14 例 AN RT-PCR 阳性结果显示,AN 拭子上进行的 LFT 敏感性为 77%(50%-92%)。15/16 对配对口腔拭子 LFT 均为阴性。

结论

LFT 的 NPV、PPV 和特异性均极佳。当样本位于同一位置时,LFT 与 RT-PCR 的敏感性相当,但当 LFT 拭子取自 AN 时,敏感性可能会降低。口腔拭子不适合用于 LFT 检测。应在医院环境中仔细考虑拭子取样的原因、儿童的耐受性以及对测试处理的要求(例如,结果的快速性)。

试验注册号

NCT04629157。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df54/9887373/49a1190a2ba9/archdischild-2022-324353f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df54/9887373/49a1190a2ba9/archdischild-2022-324353f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df54/9887373/49a1190a2ba9/archdischild-2022-324353f01.jpg

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