Evaluation of the QlAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV-2 Detection

被引：77

作者：

Visseaux, Benoit ^{[1
,2
]}

Le Hingrat, Quentin ^{[1
,2
]}

Collin, Gilles ^{[1
,2
]}

Bouzid, Donia ^{[2
,3
]}

Lebourgeois, Samuel ^{[1
,2
]}

Le Pluart, Diane ^{[4
]}

Deconinck, Laurene ^{[4
]}

Lescure, Francois-Xavier ^{[2
,4
]}

Lucet, Jean-Christophe ^{[2
,5
]}

Bouadma, Lila ^{[2
,6
]}

Timsit, Jean-Francois ^{[2
,6
]}

Descamps, Diane ^{[1
,2
]}

Yazdanpanah, Yazdan ^{[2
,4
]}

Casalino, Enrique ^{[2
,3
]}

Houhou-Fidouh, Nadhira ^{[1
]}

机构：

[1] Univ Paris, Hop Bichat, AP HP, Serv Virol, Paris, France

[2] Univ Paris, INSERM, Decis Sci Infect Dis Control & Care DeSCID, UMR 1137,IAME, Paris, France

[3] Univ Paris, Hop Bichat, AP HP, Serv Accueil Urgences, Paris, France

[4] Univ Paris, Hop Bichat Claude Bernard, AP HP, Serv Malad Infect & Trop, Paris, France

[5] Univ Paris, Hop Bichat Claude Bernard, AP HP, Unite Hyg & Lutte Infect Nosocomiales, Paris, France

[6] Univ Paris, Hop Bichat Claude Bernard, AP HP, Reanimat Med & Infect, Paris, France

来源：

JOURNAL OF CLINICAL MICROBIOLOGY | 2020年 / 58卷 / 08期

关键词：

COVID-19; SARS-CoV-2; diagnostics; mPCR; rapid tests;

D O I：

10.1128/JCM.00630-20

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

In the race to contain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work, we performed the first evaluation of the QlAstat-Dx respiratory SARS-CoV-2 panel (QlAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay, including SARS-CoV-2 detection, and is fully compatible with a non-PCR-trained laboratory or point-of-care (PoC) testing. This evaluation was performed using 69 primary clinical samples (66 nasopharyngeal swabs [NPS], 1 bronchoalveolar lavage fluid sample [BAL], 1 tracheal aspirate sample, and 1 bronchial aspirate sample) comparing SARS-CoV-2 detection with the currently WHO-recommended reverse transcription-PCR (RT-PCR) (WHO-RT-PCR) workflow. Additionally, a comparative limit of detection (LoD) assessment was performed for QlAstat-SARS and WHO-RT-PCR using a quantified clinical sample. Compatibility of sample pretreatment for viral neutralization or viscous samples with the QlAstat-SARS system were also tested. The QlAstat-Dx respiratory SARS-CoV-2 panel demonstrated a sensitivity comparable to that of the WHO-recommended assay with a limit of detection at 1,000 copies/ml. The overall percent agreement between QlAstat-Dx SARS and WHO-RT-PCR on 69 clinical samples was 97% with a sensitivity of 100% (40/40) and specificity at 93% (27/29). No cross-reaction was encountered for any other respiratory viruses or bacteria included in the panel. The QlAstat-SARS rapid multiplex PCR panel provides a highly sensitive, robust, and accurate assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR-trained laboratory or point-of-care testing, allowing innovative organization.

引用

页数：5