Evaluation of the automated cartridge-based ARIES SARS-CoV-2 Assay (RUO) against automated Cepheid Xpert Xpress SARS-CoV-2 PCR as gold standard

Abstract

Introduction 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. Methods 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. Results 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. Conclusions 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.

Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

“…For containment purposes, direct proof of virus RNA in respiratory samples is of central importance, so molecular tools for the detection of SARS-CoV-2 virus RNA were rapidly introduced and evaluated [ 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ] at early stages of the pandemic. However, detectable amounts of virus RNA can quickly decline over the course of the disease [ 12 , 15 ], so infected individuals with lacking or mild symptoms have a good chance of going undetected if surveillance is just based on molecular diagnostic approaches.…”

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021

“…The study by Zheng et al 41 evaluating an unnamed lateral flow dipstick assay is one example. Another example is the work of Tanida et al 42 , evaluating the ARIES SARS-CoV-2 Assay; this study was excluded as the comparison was made against another POC assay (Xpert Xpress SARS-CoV-2) and used patient samples with defined copy numbers and synthetically spiked samples.…”

Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR

“…All these assays were applied according to the manufacturers’ guidelines [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 38 , 61 , 62 ]. Comparative PCR testing as gold standard for the antigen test assessment was performed either by the Roche Cobas SARS-CoV-2 PCR (Roche, Basel, Switzerland) [ 13 , 65 ], the Genesig Real-Time PCR Coronavirus (COVID-19) assay (Primerdesign Ltd., Chandlers Ford, UK) [ 66 ], or the Cepheid Xpert Xpress SARS-CoV-2 PCR (Cepheid, Sunnyvale, CA, USA) [ 13 , 14 ]. The choice of the PCR assay depended on availability in the diagnostic routine.…”

“…Cepheid’s (Sunnyvale, CA, USA) GeneXpert system and Abbott’s (Chicago, IL, USA) ID Now system were the first broadly available assays showing good performance characteristics in a Cochrane analysis published as early as in August 2020 [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. Additionally, Luminex’s (Austin, TX, USA) cartridge-based ARIES PCR system allowed fully automated testing comparably early [ 14 , 15 ]. Another fully automated CE certified and FDA cleared approach for the detection of SARS-CoV-2 nucleic acids from upper respiratory tract specimens is the Hologic Aptima SARS-CoV-2 TMA assay on the Hologic Panther platform [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ].…”

“…Although easy to apply with little training effort for laboratory personnel, such fully-automated POCT-like molecular approaches still have considerable limitations. Firstly, many of them [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ] are poorly suited for large scale assessments. Secondly, there has been a shortage of consumables from the beginning of the SARS-CoV-2 pandemic.…”