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罗氏 Panther SARS-CoV-2 检测在 SARS-CoV-2 检测中的作用:筛查还是诊断技术?

Role of Hologic® Panther AptimaTM SARS-CoV-2 assay in the detection of SARS-CoV-2: screening or diagnostic technique?

机构信息

Cristina García Salguero. Microbiology Department. Hospital Clínico San Carlos. Calle Profesor Martín Lagos, s/n, 28040, Madrid. Spain.

出版信息

Rev Esp Quimioter. 2023 Oct;36(5):516-518. doi: 10.37201/req/135.2022. Epub 2023 Jun 2.

DOI:10.37201/req/135.2022
PMID:37265449
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10586743/
Abstract

During the multiple waves of COVID-19 suffered all over the world, having a rapid and sensitive diagnostic test has become a priority for microbiology laboratories. The AptimaTM SARS-CoV-2 transcription-mediated amplification (TMA) assay running on the Panther system (Hologic) was presented as a very good option to cover this need. To evaluate this system, 570 respiratory samples were included in the study and were processed both by the Panther (Hologic) system and by qRT-PCR (Thermo Fisher Science, Waltham, USA), current assay for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A high number of false positives (n=76) was obtained with Panther system (Hologic), but the number of false positives decreases as the relative light units (RLU) value increases. These results show that this technique can be a good option for sample screening but checking for positive results should be mandatory, especially those with low RLU values.

摘要

在全球遭遇的多波 COVID-19 疫情中,拥有快速且灵敏的诊断检测方法成为微生物学实验室的首要任务。 Panther 系统(Hologic)上运行的 AptimaTM SARS-CoV-2 转录介导扩增(TMA)检测已被证明是满足这一需求的绝佳选择。为了评估该系统,本研究纳入了 570 份呼吸道样本,同时使用 Panther(Hologic)系统和 qRT-PCR(美国 Thermo Fisher Science,Waltham)进行检测,后者是目前用于诊断严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的方法。Panther 系统(Hologic)得到了大量的假阳性结果(n=76),但随着相对光单位(RLU)值的增加,假阳性的数量会减少。这些结果表明,该技术可能是样本筛选的不错选择,但应强制检查阳性结果,尤其是那些 RLU 值较低的结果。

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Comparison of two nucleic acid amplification tests (NAATs) and two antigen tests for detection of SARS-CoV-2 from upper respiratory specimens.两种核酸扩增检测(NAATs)与两种抗原检测用于从上呼吸道标本中检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的比较。
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