Background/Purpose

Mass screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is important to prevent the spread of coronavirus disease 2019 (COVID-19). Pooling samples can increase the number of tests processed. LabTurbo AIO 48 is an automated platform that allows ribonucleic acid extraction and sample analysis on the same instrument. We created a novel pooling assay on this platform for SARS-CoV-2 detection and demonstrated that the pooling strategy increases testing capacity without affecting accuracy and sensitivity.

Methods

Comparative limit of detection (LoD) assessment was performed on the LabTurbo AIO 48 platform and the current standard detection system based on real-time reverse transcription polymerase chain reaction (rRT-PCR) using 55 clinically positive samples. An additional 330 primary clinical samples were assessed.

Results

Six samples pooled into one reaction tube were detected in approximately 2.5 h using the World Health Organization rRT-PCR protocol. LabTurbo AIO 48 also demonstrated a higher throughput than our reference rRT-PCR assay, with an LoD of 1000 copies/mL. The overall percentage agreement between the methods for the 330 samples was 100%.

Conclusion

We created a novel multi-specimen pooling assay using LabTurbo AIO 48 for the robust detection of SARS-CoV-2, allowing high-throughput results; this assay will aid in better control and prevention of COVID-19. The diagnostic assay was cost-effective and time-efficient; thus, the pooling strategy is a practical and effective method for diagnosing large quantities of specimens without compromising precision.

中文翻译：

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评估用于检测 SARS-CoV-2 的新型多样本汇集分析的多中心研究：高灵敏度和高通量测试

背景/目的

严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 的大规模筛查对于预防 2019 年冠状病毒病 (COVID-19) 的传播非常重要。合并样本可以增加处理的测试数量。LabTurbo AIO 48 是一个自动化平台，允许在同一台仪器上进行核糖核酸提取和样品分析。我们在该平台上创建了一种用于 SARS-CoV-2 检测的新型汇集分析，并证明汇集策略可提高检测能力，而不会影响准确性和灵敏度。

方法

使用 55 个临床阳性样本，在 LabTurbo AIO 48 平台和基于实时逆转录聚合酶链反应 (rRT-PCR) 的当前标准检测系统上进行比较检测限 (LoD) 评估。评估了另外 330 个主要临床样本。

结果

使用世界卫生组织 rRT-PCR 协​​议，在大约 2.5 小时内检测到汇集到一个反应管中的六个样本。LabTurbo AIO 48 还展示了比我们的参考 rRT-PCR 检测更高的通量，LoD 为 1000 拷贝/mL。330 个样品的方法之间的总体一致性百分比为 100%。

结论

我们使用 LabTurbo AIO 48 创建了一种新型多样本合并分析，用于 SARS-CoV-2 的稳健检测，从而获得高通量结果；该测定将有助于更好地控制和预防 COVID-19。诊断分析具有成本效益和时间效率；因此，合并策略是一种实用且有效的方法，可在不影响精度的情况下诊断大量标本​​。