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在Hologic Panther平台上,口咽/鼻咽样本和唾液样本中SARS-CoV-2检测的敏感性相似。

Similar Sensitivity of SARS-CoV-2 Detection in Oropharyngeal/Nasopharyngeal and Saliva Samples on the Hologic Panther Platform.

作者信息

Vahidnia Ali, Souverein Dennis, Euser Sjoerd M, Haverkort Milly, Noordhuis Elise, van Zijl Thomas Z I, Kalpoe Jayant, Sinnige Jan C, Herpers Bjorn L

机构信息

Regional Public Health Laboratory Kennemerland, 2035 RC Haarlem, The Netherlands.

Public Health Service Kennemerland, 2015 CK Haarlem, The Netherlands.

出版信息

Diagnostics (Basel). 2023 Jan 18;13(3):347. doi: 10.3390/diagnostics13030347.

Abstract

BACKGROUND

Oropharyngeal (OP) and nasopharyngeal (NP) sampling has historically been considered the reference specimen type used for respiratory virus detection. Saliva could be a less invasive alternative for SARS-CoV-2 detection, but limited evidence is available.

METHODS

The technical and clinical performance of saliva was compared to OP/NP on the Hologic Panther platform with two Aptima assays, the End-Point Transcription-Mediated Amplification assay (EP-TMA) and Real-Time Transcription-Mediated Amplification assay (RT-TMA). The samples were collected at the Public Health Service Testing Site XL location in Schiphol Amsterdam Airport. At the site, the Regional Public Health Laboratory Kennemerland (RPHLK) has a fully equipped laboratory facility.

RESULTS

A total of 374 samples (187 OP/NP swabs and 187 saliva samples) were collected from 187 unique patients. The Real-Time Transcription-Mediated Amplification assay (RT-TMA) resulted in comparable sensitivities for the detection of SARS-CoV-2 in both the OP/NP swabs (88.3%; 113/128) and saliva samples (87.5%; 112/128). The End-Point Transcription-Mediated Amplification assay (EP-TMA) analyses showed a similar sensitivity (86.7%; 111/128) in the OP/NP swabs but a lower sensitivity in the saliva samples (80.5%; 103/128). Within the discordant analyses, we found no associations in the symptoms, earlier SARS-CoV-2 infections and eating, smoking, drinking and tooth brushing habits within one hour before testing.

CONCLUSIONS

The Hologic Panther platform Real-Time Transcription-Mediated Amplification assay (RT-TMA) yields a sensitivity for the detection of SARS-CoV-2 in saliva that is comparable to the OP/NP swabs derived from participants presenting themselves at a public health testing facility with minimal or mild symptoms.

摘要

背景

口咽(OP)和鼻咽(NP)采样历来被视为用于呼吸道病毒检测的参考样本类型。唾液可能是一种侵入性较小的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)检测替代方法,但相关证据有限。

方法

在Hologic Panther平台上,使用两种Aptima检测方法,即终点转录介导扩增检测(EP-TMA)和实时转录介导扩增检测(RT-TMA),将唾液的技术和临床性能与OP/NP进行比较。样本在阿姆斯特丹史基浦机场的公共卫生服务检测点XL采集。在该地点,肯内默兰地区公共卫生实验室(RPHLK)拥有设备齐全的实验室设施。

结果

共从187名患者中采集了374份样本(187份OP/NP拭子和187份唾液样本)。实时转录介导扩增检测(RT-TMA)对OP/NP拭子(88.3%;113/128)和唾液样本(87.5%;112/128)中SARS-CoV-2的检测灵敏度相当。终点转录介导扩增检测(EP-TMA)分析显示,OP/NP拭子中的灵敏度相似(86.7%;111/128),但唾液样本中的灵敏度较低(80.5%;103/128)。在不一致的分析中,我们未发现症状、既往SARS-CoV-2感染以及检测前一小时内的饮食、吸烟、饮酒和刷牙习惯之间存在关联。

结论

Hologic Panther平台的实时转录介导扩增检测(RT-TMA)对唾液中SARS-CoV-2的检测灵敏度与在公共卫生检测机构就诊的症状轻微或无明显症状参与者的OP/NP拭子相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33e6/9914531/bd59b51190db/diagnostics-13-00347-g001.jpg

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