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对从既往感染过严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的队列中采集的干血斑进行SARS-CoV-2抗体检测的血清学检测方法评估。

Evaluation of serological assays for SARS-CoV-2 antibody testing from dried blood spots collected from cohorts with prior SARS-CoV-2 infection.

作者信息

Catlett Beth, Starr Mitchell, Machalek Dorothy A, Danwilai Thidarat, Palmer Michael, Kelly Andrew, Kaldor John, Dore Gregory J, Darley David, Matthews Gail, Cunningham Philip H

机构信息

NSW State Reference Laboratory for HIV, St Vincent's Centre for Applied Medical Research, Darlinghurst, Sydney, New South Wales, Australia.

The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.

出版信息

J Clin Virol Plus. 2022 Aug;2(3):100093. doi: 10.1016/j.jcvp.2022.100093. Epub 2022 Jun 24.

Abstract

BACKGROUND

Dried blood spot (DBS) specimens are a useful serosurveillance tool particularly in hard-to-reach populations but their application for detecting SARS-CoV-2 infection is poorly characterised.

OBJECTIVES

To compare detection of naturally acquired SARS-CoV-2 antibodies in paired DBS and serum specimens using commercially available serological immunoassays.

STUDY DESIGN

Specimens were collected through St Vincent's Hospital observational post COVID-19 cohort study (ADAPT). Laboratory spotted DBS from venepuncture were initially tested on seven assays, a DBS validation completed on three with clinically collected fingerstick DBSs tested on one.

RESULTS

Sensitivity for Euroimmun nucleocapsid (NCP) IgG ELISA from laboratory spotted DBS (n=145), Euroimmun spike, IgG ELISA from laboratory spotted DBS (n=161), and Binding Site total antibody ELISA from clinically collected fingerstick DBS (n=391) was 100% (95% CI: 95.8-100%), 100% (95% CI: 95.8-100%) and 92.9% (95% CI: 89.5-95.5%), respectively. Specificity was 66.2% (95% CI: 53.6-77.0%), 96% (95% CI: 88.7-99.1%) and 98.8% (95% CI: 93.3-99.9%), respectively. All three assays' results displayed a strong positive correlation between DBS compared to paired serum.

CONCLUSIONS

The Binding Site™ spike total antibody and Euroimmun™ spike IgG ELISAs provided good analytical performance, demonstrating that DBS specimens could facilitate specimen collection in the epidemiological surveillance of SARS-CoV-2 infection. This is highly applicable in populations and settings where venepuncture is problematic (including community based regional/remote settings, nursing homes, prisons, and schools).

摘要

背景

干血斑(DBS)标本是一种有用的血清学监测工具,尤其适用于难以接触到的人群,但其在检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染方面的应用特征尚不明确。

目的

使用市售血清学免疫测定法比较配对的DBS和血清标本中自然获得的SARS-CoV-2抗体的检测情况。

研究设计

标本通过圣文森特医院COVID-19队列观察性研究(ADAPT)收集。最初对静脉穿刺采集的实验室点样DBS进行了7种检测,对其中3种检测完成了DBS验证,并对1种临床采集的指尖DBS进行了检测。

结果

实验室点样DBS(n = 145)的欧蒙核衣壳(NCP)IgG酶联免疫吸附测定(ELISA)、实验室点样DBS(n = 161)的欧蒙刺突蛋白IgG ELISA以及临床采集的指尖DBS(n = 391)的Binding Site总抗体ELISA的灵敏度分别为100%(95%置信区间:95.8 - 100%)、100%(95%置信区间:95.8 - 100%)和92.9%(95%置信区间:89.5 - 95.5%)。特异性分别为66.2%(95%置信区间:53.6 - 77.0%)、96%(95%置信区间:88.7 - 99.1%)和98.8%(95%置信区间:93.3 - 99.9%)。与配对血清相比,所有三种检测方法的结果在DBS之间均显示出强正相关。

结论

Binding Site™刺突蛋白总抗体和欧蒙™刺突蛋白IgG ELISA具有良好的分析性能,表明DBS标本有助于SARS-CoV-2感染的流行病学监测中的标本采集。这在静脉穿刺存在问题的人群和环境中(包括社区基层地区/偏远地区、养老院、监狱和学校)具有高度适用性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba86/9225964/7bdd41298a52/gr1_lrg.jpg

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