Tanida Konstantin, Koste Lars, Koenig Christian, Wenzel Werner, Fritsch Andreas, Frickmann Hagen
1Department of Microbiology and Hospital Hygiene, Bundeswehr Hospital Hamburg, Hamburg, Germany.
2Department of Laboratory Medicine, Bundeswehr Hospital Hamburg, Hamburg, Germany.
Eur J Microbiol Immunol (Bp). 2020 Aug 17;10(3):156-164. doi: 10.1556/1886.2020.00017.
To evaluate the automated cartridge-based PCR approach ARIES SARS-CoV-2 Assay targeting the ORF-sequence and the N-gene of SARS-CoV-2.
In line with the suggestions by Rabenau and colleagues, the automated ARIES SARS-CoV-2 Assay was challenged with strongly positive samples, weakly positive samples and negative samples. Further, intra-assay and inter-assay precision as well as the limit-of-detection (lod) were defined with quantified target RNA and DNA. The Cepheid Xpert Xpress SARS-Cov-2 Assay was used as gold standard.
Concordance between the ARIES assay and the Cepheid assay was 100% for strongly positive samples and for negative samples, respectively. For weakly positive samples as confirmed applying the Cepheid assay, a relevant minority of 4 out of 15 samples (26.7%) went undetected by the ARIES assay. Intra- and inter-assay precision were satisfactory, while the lod was in the 103 DNA copies/reaction-range, in the 103 virus copies/reaction-range, or in the 103-104 free RNA copies/reaction-range in our hands.
The automated ARIES assay shows comparable test characteristics as the Cepheid assay focusing on strongly positive and negative samples but a slightly reduced sensitivity with weakly positive samples. Decisions on diagnostic use should include considerations on the lod.
评估基于试剂盒的自动化PCR方法——ARIES SARS-CoV-2检测法，该方法针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的开放阅读框序列和核衣壳蛋白基因（N基因）。
按照拉贝瑙及其同事的建议，使用强阳性样本、弱阳性样本和阴性样本对自动化的ARIES SARS-CoV-2检测法进行测试。此外，使用定量的靶RNA和DNA来确定检测内和检测间的精密度以及检测限（lod）。以赛沛Xpert Xpress SARS-CoV-2检测法作为金标准。
ARIES检测法与赛沛检测法之间，强阳性样本和阴性样本的一致性分别为100%。对于经赛沛检测法确认为弱阳性的样本，15个样本中有4个（26.7%）被ARIES检测法漏检。检测内和检测间的精密度令人满意，而在我们的实验中，检测限处于10³个DNA拷贝/反应范围、10³个病毒拷贝/反应范围或10³-10⁴个游离RNA拷贝/反应范围内。
自动化的ARIES检测法在针对强阳性和阴性样本时，显示出与赛沛检测法相当的检测特性，但对弱阳性样本的敏感性略有降低。关于诊断用途的决策应考虑检测限。
