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用于SARS-CoV-2抗体检测的血液自我采集系统与常规静脉穿刺采血的比较。

Comparison of a Blood Self-Collection System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing.

作者信息

Wixted Douglas, Neighbors Coralei E, Pieper Carl F, Wu Angie, Kingsbury Carla, Register Heidi, Petzold Elizabeth, Newby L Kristin, Woods Christopher W

机构信息

Duke Clinical and Translational Science Institute, Duke University, Durham, NC 27701, USA.

Duke Global Health Institute, Duke University, Durham, NC 27710, USA.

出版信息

Diagnostics (Basel). 2022 Jul 31;12(8):1857. doi: 10.3390/diagnostics12081857.

Abstract

The Coronavirus Disease 2019 (COVID-19) pandemic forced researchers to reconsider in-person assessments due to transmission risk. We conducted a pilot study to evaluate the feasibility of using the Tasso-SST (Tasso, Inc, Seattle, Washington) device for blood self-collection for use in SARS-CoV-2 antibody testing in an ongoing COVID-19 prevalence and immunity research study. 100 participants were recruited between January and March 2021 from a previously identified sub-cohort of the Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study who were under-going bimonthly COVID-19 antibody testing. Participants were given a Tasso-SST kit and asked to self-collect blood during a scheduled visit where trained laboratory personnel performed routine phlebotomy. All participants completed an after-visit survey about their experience. Overall, 70.0% of participants were able to collect an adequate sample for testing using the device. Among those with an adequate sample, there was a high concordance in results between the Tasso-SST and phlebotomy blood collection methods (Cohen’s kappa coefficient = 0.88, Interclass correlation coefficient 0.98 [0.97, 0.99], p < 0.0001). The device received a high-level (90.0%) of acceptance among all participants. Overall, the Tasso-SST could prove to be a valuable tool for seroprevalence testing. However, future studies in larger, diverse populations over longer periods may provide a better understanding of device usability and acceptance among older participants and those with comorbidities in various use scenarios.

摘要

2019年冠状病毒病(COVID-19)大流行因传播风险迫使研究人员重新考虑现场评估。我们进行了一项试点研究,以评估在一项正在进行的COVID-19流行率和免疫研究中,使用Tasso-SST(Tasso公司,华盛顿州西雅图)设备进行血液自我采集用于SARS-CoV-2抗体检测的可行性。2021年1月至3月期间,从卡巴鲁斯县COVID-19流行率和免疫(C3PI)研究先前确定的一个亚队列中招募了100名参与者,这些参与者正在接受每两个月一次的COVID-19抗体检测。参与者被给予一个Tasso-SST试剂盒,并被要求在预定的访视期间自行采集血液,在此期间,经过培训的实验室人员会进行常规静脉穿刺采血。所有参与者都完成了关于他们体验的访视后调查。总体而言,70.0%的参与者能够使用该设备采集到足够的检测样本。在采集到足够样本的参与者中,Tasso-SST和静脉穿刺采血方法之间的结果一致性很高(科恩卡方系数 = 0.88,组内相关系数0.98 [0.97, 0.99],p < 0.0001)。该设备在所有参与者中获得了较高水平(90.0%)的接受度。总体而言,Tasso-SST可能被证明是血清流行率检测的一个有价值的工具。然而,未来在更大、更多样化的人群中进行更长时间的研究,可能会更好地了解该设备在不同使用场景下老年参与者和患有合并症者中的可用性和接受度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7c74/9406345/20b954ab226a/diagnostics-12-01857-g0A1.jpg

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