Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave.
Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave.
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DOI：
10.1371/journal.pone.0249791
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Edgeworth JD
中科院分区：
文献类型：
--
作者：
Sweeney N;Merrick B;Pedro Galão R;Pickering S;Botgros A;Wilson HD;Signell AW;Betancor G;Tan MKI;Ramble J;Kouphou N;Acors S;Graham C;Seow J;MacMahon E;Neil SJD;Malim MH;Doores K;Douthwaite S;Batra R;Nebbia G;Edgeworth JD
在第一波全球COVID-19大流行期间，SARS-CoV-2血清学检测的临床效用和适应症尚未明确界定。部署血清学检测的紧迫性要求对其性能特征进行快速评价。我们使用SARS-CoV-2 RNA阳性个体的血清和大流行前样本对CE认证的侧流免疫测定（LFIA）（SureScreen Diagnostics）进行了内部验证。随后在伦敦中心教学医院使用LFIA对经审查的转诊患者提供当天指定的SARS-CoV-2血清学服务，并向直接护理团队提供结果的临床解释。分析性能，转诊的来源和性质，服务的可行性和临床效用，特别是临床决策的好处，进行了记录。LFIA的敏感性和特异性分别为96.1%和99.3%。在为期三周的试点期间，对108名参与者进行了113次测试。44%的参与者（n = 48）有可检测的抗体。确定了血清学检测的三个主要适应症：近期COVID-19可能引发的新的急性表现，例如肺栓塞（n = 5），近期COVID-19相容性疾病背景下的潜在漏诊（n = 40），以及在持续SARS-CoV-2 RNA PCR阳性个体中做出感染控制或免疫抑制管理决策（n = 6）。我们证明了使用LFIA检测抗刺突抗体在成人和儿童中提供SARS-CoV-2血清学服务的可接受的性能特征、可行性和临床实用性。最大的好处是看到有合理的预测试概率和结果可以与临床建议或干预。随着大流行的发展，该试点项目的经验可以帮助了解在临床服务中快速实施LFIAs等新检测的实用性和益处。
During the first wave of the global COVID-19 pandemic the clinical utility and indications for SARS-CoV-2 serological testing were not clearly defined. The urgency to deploy serological assays required rapid evaluation of their performance characteristics. We undertook an internal validation of a CE marked lateral flow immunoassay (LFIA) (SureScreen Diagnostics) using serum from SARS-CoV-2 RNA positive individuals and pre-pandemic samples. This was followed by the delivery of a same-day named patient SARS-CoV-2 serology service using LFIA on vetted referrals at central London teaching hospital with clinical interpretation of result provided to the direct care team. Assay performance, source and nature of referrals, feasibility and clinical utility of the service, particularly benefit in clinical decision-making, were recorded. Sensitivity and specificity of LFIA were 96.1% and 99.3% respectively. 113 tests were performed on 108 participants during three-week pilot. 44% participants (n = 48) had detectable antibodies. Three main indications were identified for serological testing; new acute presentations potentially triggered by recent COVID-19 e.g. pulmonary embolism (n = 5), potential missed diagnoses in context of a recent COVID-19 compatible illness (n = 40), and making infection control or immunosuppression management decisions in persistently SARS-CoV-2 RNA PCR positive individuals (n = 6). We demonstrate acceptable performance characteristics, feasibility and clinical utility of using a LFIA that detects anti-spike antibodies to deliver SARS-CoV-2 serology service in adults and children. Greatest benefit was seen where there is reasonable pre-test probability and results can be linked with clinical advice or intervention. Experience from this pilot can help inform practicalities and benefits of rapidly implementing new tests such as LFIAs into clinical service as the pandemic evolves.
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