The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology.
The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology.
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DOI：
10.1038/s41598-023-35479-9
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发表时间：
2023-06-17
影响因子：
4.6
通讯作者：
中科院分区：
文献类型：
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作者：
准确和快速的床旁诊断对控制COVID-19大流行至关重要。目前准确诊断SARS-CoV-2的标准是基于实验室的逆转录聚合酶链反应（RT-PCR）检测。本文报告了QuantuMDx Q-POC SARS-CoV-2 RT-PCR检测试剂盒的初步前瞻性性能评价。2020年11月至2021年3月期间，在伦敦圣乔治医院获得了来自29名因RT-PCR确诊COVID-19住院的个体的49份纵向组合鼻/喉（NT）拭子。此外，于2021年6月从健康志愿者中获得了101份中鼻（MN）拭子。这些样本用于评价Q-POC SARS-CoV-2 RT-PCR检测。主要分析是比较Q-POC检测与参考实验室RT-PCR检测的灵敏度和特异性。当参考检测的循环阈值（Ct）临界值为35时，Q-POC检测与参考检测相比的总体灵敏度为96.88%（83.78- 99.92% CI），而在参考检测的Ct临界值为40的情况下，Q-POC检测与参考检测相比的总体灵敏度为80.00%（64.35-90.95% CI）。Q-POC检测是一种灵敏、特异和快速的SARS-CoV-2检测方法，参考Ct截止值为35。Q-POC检测为实时RT-PCR提供了一个准确的选择，无需样品预处理和实验室处理，从而能够在急性护理和其他环境中进行快速诊断和临床分诊。
Accurate and rapid point-of-care (PoC) diagnostics are critical to the control of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR) assays. Here, a preliminary prospective performance evaluation of the QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay is reported. Between November 2020 and March 2021, 49 longitudinal combined nose/throat (NT) swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 were obtained at St George’s Hospital, London. In addition, 101 mid-nasal (MN) swabs were obtained from healthy volunteers in June 2021. These samples were used to evaluate the Q-POC SARS-CoV-2 RT-PCR assay. The primary analysis was to compare the sensitivity and specificity of the Q-POC test against a reference laboratory-based RT-PCR assay. The overall sensitivity of the Q-POC test compared with the reference test was 96.88% (83.78– 99.92% CI) for a cycle threshold (Ct) cut-off value for the reference test of 35 and 80.00% (64.35–90.95% CI) without altering the reference test’s Ct cut-off value of 40. The Q-POC test is a sensitive, specific and rapid PoC test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC test provides an accurate option for RT-PCR at PoC without the need for sample pre-processing and laboratory handling, enabling rapid diagnosis and clinical triage in acute care and other settings.
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影响因子：
9.4
作者：
Assennato SM;Ritchie AV;Nadala C;Goel N;Tie C;Nadala LM;Zhang H;Datir R;Gupta RK;Curran MD;Lee HH
通讯作者：
Lee HH
影响因子：
3.6
作者：
Chen, Chao-Ju;Hsieh, Li-Ling;Lu, Po-Liang
通讯作者：
Lu, Po-Liang
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier
影响因子：
14.2
作者：
Shengchen, D.;Gu, X.;Cao, B.
通讯作者：
Cao, B.
DOI：
10.1093/jac/dkab241
发表时间：
2021-09-23
期刊：
The Journal of antimicrobial chemotherapy
影响因子：
--
作者：
Bouzid D;Casalino E;Mullaert J;Laurent O;Duval X;Lescure FX;Peiffer Smadja N;Tubiana S;Armand Lefèvre L;Descamps D;Fidouh N;Choquet C;Lucet JC;Visseaux B
通讯作者：
Visseaux B