Altawalah Haya, Alfouzan Wadha, Al-Fadalah Talal, Ezzikouri Sayeh
Department of Microbiology, Faculty of Medicine, Kuwait University, Safat 24923, Kuwait.
Virology Unit, Yacoub Behbehani Center, Sabah Hospital, Ministry of Health, Safat 24923, Kuwait.
Diagnostics (Basel). 2021 Nov 15;11(11):2110. doi: 10.3390/diagnostics11112110.
To control the spread of the pandemic brought about by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, it is necessary to have an automated reliable diagnostic assay. To date, the RT-PCR (RT-qPCR) has been the recommended laboratory method to diagnose SARS-CoV-2 infection, but there is a need for more automated and reliable tests. The aim of this real-life study was to assess the diagnostic performance of DiaSorin's LIAISON SARS-CoV-2 antigen (Ag) chemiluminescence immunoassay in detecting SARS-CoV-2 in vaccinated and unvaccinated individuals.
A prospective study was performed on 300 nasopharyngeal swabs randomly collected from 31 May to 6 July 2021. Nasopharyngeal samples were assayed with DiaSorin's LIAISON SARS-CoV-2 Ag and TaqPath™ COVID-19 multiplex RT-qPCR.
Of 300 participants, 150 had a RT-qPCR confirmed SARS-CoV-2 infection of whom 113 (75.33%) were also detected by the DiaSorin LIAISON SARS-CoV-2 Ag. Taking RT-qPCR as a reference, the sensitivity and specificity of the DiaSorin LIAISON SARS-CoV-2 Ag assay were evaluated as 75.33% (95% CI = 67.64-82) and 100% (95% CI = 97.57-100), respectively. When a viral load cut-off was applied for high viral load (median cycle threshold (Ct) < 18.57), the overall sensitivity was increased to 96.55% (95% CI = 88.09-99.58). Interestingly, median RT-qPCR Ct and SARS-CoV-2 Ag values were similar between fully vaccinated and unvaccinated subjects.
Automated, quantitative LIAISON SARS-CoV-2 Ag assay shows good performance to identify SARS-CoV-2-infected individuals with moderate to high viral loads. LIAISON SARS-CoV-2 Ag testing could be used as frontline testing for COVID-19 diagnosis and be more suitable for large utilization.
为控制严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染引发的大流行的传播，有必要拥有一种自动化的可靠诊断检测方法。迄今为止，逆转录聚合酶链反应（RT-PCR，即RT-qPCR）一直是诊断SARS-CoV-2感染的推荐实验室方法，但仍需要更自动化、更可靠的检测方法。这项实际研究的目的是评估DiaSorin公司的LIAISON SARS-CoV-2抗原（Ag）化学发光免疫分析在检测接种疫苗和未接种疫苗个体中的SARS-CoV-2时的诊断性能。
对2021年5月31日至7月6日随机采集的300份鼻咽拭子进行了一项前瞻性研究。鼻咽样本采用DiaSorin公司的LIAISON SARS-CoV-2 Ag和TaqPath™ COVID-19多重RT-qPCR进行检测。
在300名参与者中，150人经RT-qPCR确诊感染了SARS-CoV-2，其中113人（75.33%）也被DiaSorin LIAISON SARS-CoV-2 Ag检测到。以RT-qPCR为参照，DiaSorin LIAISON SARS-CoV-2 Ag检测的灵敏度和特异性分别评估为75.33%（95%置信区间=67.64-82）和100%（95%置信区间=97.57-100）。当对高病毒载量应用病毒载量截断值（中位循环阈值（Ct）<18.57）时，总体灵敏度提高到96.55%（95%置信区间=88.09-99.58）。有趣的是，完全接种疫苗和未接种疫苗的受试者之间，RT-qPCR Ct中位值和SARS-CoV-2 Ag值相似。
自动化的定量LIAISON SARS-CoV-2 Ag检测在识别具有中度至高度病毒载量的SARS-CoV-2感染个体方面表现良好。LIAISON SARS-CoV-2 Ag检测可作为COVID-19诊断的一线检测方法，更适合大规模应用。
