Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2.
Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2.
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DOI：
10.1128/jcm.01262-20
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发表时间：
2020-12-17
影响因子：
9.4
通讯作者：
Lee HH
中科院分区：
文献类型：
--
作者：
Assennato SM;Ritchie AV;Nadala C;Goel N;Tie C;Nadala LM;Zhang H;Datir R;Gupta RK;Curran MD;Lee HH
用于检测呼吸道样本中严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) RNA 的核酸扩增是诊断的标准方法。大部分测试都是集中进行的，因此周转时间为几天。在需要快速做出患者管理和感染控制决策的环境中，具有快速周转时间的即时护理 (POC) 测试将能够更有效地进行分类。基于简单扩增的检测 (SAMBA) II SARS-CoV-2 测试的包容性和特异性是通过引物和探针的计算机分析以及湿测试来确定的。用于检测呼吸道样本中严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) RNA 的核酸扩增是诊断的标准方法。大部分测试都是集中进行的，因此周转时间为几天。在需要快速做出患者管理和感染控制决策的环境中，具有快速周转时间的即时护理 (POC) 测试将能够更有效地进行分类。基于简单扩增的检测 (SAMBA) II SARS-CoV-2 测试的包容性和特异性是通过引物和探针的计算机分析以及湿测试来确定的。对 SAMBA II SARS-CoV-2 测试的性能特征进行了评估。通过残留的咽喉/鼻拭子组合评估临床表现，并与英国公共卫生部针对 RdRp 基因的实时 PCR 检测结果进行比较。 SAMBA II SARS-CoV-2 测试的分析灵敏度为 250 拷贝/ml，可检测基因组的两个区域（开放阅读框 1ab [ORF1ab] 和核衣壳蛋白 [N]）。临床表现通过剑桥阿登布鲁克医院临床微生物学和公共卫生实验室 (CMPHL) 提供的 172 份残留联合鼻/咽拭子进行评估，结果显示，与对照组相比，估计阳性一致性百分比为 98.9%（95% 置信区间 [CI]，93.83 至 99.97），阴性一致性百分比为 96.4%（95% CI，89.92 至 99.26）。 由 CMPHL 进行测试。数据显示，SAMBA II SARS-CoV-2 测试的性能与集中测试方法相当，但周转时间更短，为 86 至 101 分钟。 SAMBA 等即时检测应能够实现快速患者管理和有效实施感染控制措施。
Nucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both in silico analyses of the primers and probes and wet testing. Nucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to that of the Public Health England real-time PCR assay targeting the RdRp gene. The SAMBA II SARS-CoV-2 test has an analytical sensitivity of 250 copies/ml for detecting two regions of the genome (open reading frame 1ab [ORF1ab] and nucleocapsid protein [N]). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% confidence interval [CI], 93.83 to 99.97) and negative percent agreement of 96.4% (95% CI, 89.92 to 99.26) compared to testing by the CMPHL. The data show that the SAMBA II SARS-CoV-2 test performs equivalently to the centralized testing methods, but with a shorter turnaround time of 86 to 101 min. Point-of-care tests such as SAMBA should enable rapid patient management and effective implementation of infection control measures.