远程医疗临床医生观察、参与者采集样本用于 SARS-CoV-2 检测的适宜性和充分性：iCollect 队列研究初步研究。
Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study.
机构信息
Rollins School of Public Health, Emory University, Atlanta, GA, United States.
Molecular Testing Labs, Vancouver, WA, United States.
出版信息
JMIR Public Health Surveill. 2020 Jun 25;6(2):e19731. doi: 10.2196/19731.
BACKGROUND
The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens.
OBJECTIVE
We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2.
METHODS
Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements.
RESULTS
Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2.
CONCLUSIONS
These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19054.
背景
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）大流行要求扩大检测机会，包括使用新型检测策略，如采集家庭样本。
目的
我们旨在了解参与者在家中采集并邮寄至实验室的咽拭子（OPS）、唾液和干血斑（DBS）标本是否足以用于 SARS-CoV-2 的诊断和血清学检测。
方法
符合条件的参与者在线同意并邮寄参与者采集套件，以支持 SARS-CoV-2 检测的三种标本采集：唾液、OPS 和 DBS。参与者在远程医疗视频预约期间进行标本采集程序，同时临床观察员观察并记录采集的适用性。实验室人员使用视觉检查和核糖核酸酶 P（RNase P）测量对样本核酸含量的定量来评估标本用于 SARS-CoV-2 逆转录聚合酶链反应和血清学检测的生物学充足性。
结果
在入组的 159 名参与者中，有 153 名（96.2%）返回了他们的套件，这些套件都包含在本分析中。所有这些参与者都参加了他们的视频预约。临床观察员评估了采集的样本，其中 147/153（96.1%）的唾液样本、146/151（96.7%）的咽拭子样本和 135/145（93.1%）的 DBS 样本质量足以提交实验室检测；100%的 OPS 样本和 98%的唾液样本的 RNase P 循环阈值<30，表明样本中含有足够的核酸用于 SARS-CoV-2 的 RNA-PCR 检测。
结论
这些初步数据表明，大多数参与者采集的 OPS、唾液和 DBS 标本适合且足以用于 SARS-CoV-2 的 RNA 和血清学检测。临床观察员认为标本采集适合检测，视觉和定量实验室评估表明标本具有足够的生物学效力。这些数据支持使用参与者采集和邮寄的标本进行 SARS-CoV-2 检测。
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