Multicenter evaluation of the QIAstat Respiratory Panel—A new rapid highly multiplexed PCR based assay for diagnosis of acute respiratory tract infections

Parčina, Marijo; Schneider, Uffe Vest; Visseaux, Benoît; Jozić, Robert; Hannet, Irene; Lisby, Jan Gorm

doi:10.1371/journal.pone.0230183

Cited by 35 publications

(27 citation statements)

References 22 publications

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“…This case would have been cancelled if either donor or recipient tested positive for SARS‐CoV‐2. One caveat is that the sensitivity and specificity of PCR testing may vary depending on the assay employed 10 . It is also unknown if persistent viral antigen shedding (positive NP PCR) has clinical or epidemiological significance for persistent infectivity/reactivation; this infant has remained SARS‐CoV‐2 PCR positive while asymptomatic.…”

Section: Discussionmentioning

confidence: 99%

A case of an Infant with SARS‐CoV‐2 hepatitis early after liver transplantation

Heinz

Griesemer

Kinney

et al. 2020

Pediatric Transplantation

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Rapidly evolving literature describes case reports of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the myriad of clinical manifestations of this infection known as coronavirus disease 2019. 1 Few studies have clinically characterized the disease in the pediatric population 2 and none in immunosuppressed children. At least one clinical report suggests that immunosuppressed patients are not at increased risk for severe disease or mortality. 3 In this report, we describe the clinical course and treatment of a 6-month-old female who underwent living related donor liver transplant (LT) from her mother and tested positive for SARS-CoV-2 four days post-operatively. In the interest of rapidly circulating information to our community, we previously published a partial description of this case focused on histopathology. 4 For the benefit of a wider pediatric transplant audience, we hope to provide more detailed information regarding the clinical course as it relates to available treatment and immunosuppression management.

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Section: Discussionmentioning

confidence: 99%

A case of an Infant with SARS‐CoV‐2 hepatitis early after liver transplantation

Heinz

Griesemer

Kinney

et al. 2020

Pediatric Transplantation

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“…In-house and commercial reverse transcription-PCR (RT-PCR) assays have been quickly developed ( 3 ). The QIAstat-Dx respiratory SARS-CoV-2 panel (QIAstat-Dx SARS) is a CE-IVD ( in vitro diagnostic) product based on the previously CE-marked QIAstat-Dx respiratory panel, a qualitative multiplexed nucleic acid-based test detecting 21 viruses and bacteria, recently developed and demonstrating performance similar to that of FilmArray RP1.7 (bioMérieux, BioFire) or Anyplex RV16 (Seegene) for human respiratory viruses ( 4 , 5 ). The QIAstat-Dx cartridge allows the loading of the nasopharyngeal swab (NPS) resuspended in transport medium through the liquid port or the direct insertion of the NPS into the cartridge without additional manipulation.…”

Section: Introductionmentioning

confidence: 99%

“…This innovative design allows sample testing on demand in any laboratory, even in a non-PCR-trained laboratory, or as a point-of-care (PoC) test with minimal training. The QIAstat-Dx SARS version of the panel adds the detection of SARS-CoV-2 in a previously unused amplification chamber, without any change for sampling, extraction, and PCR conditions for detection of other respiratory viruses (4,5). As for a few other rapid PCR assays available thus far, results are provided in about 1 h, compared to the labor-intensive 3 to 4 h in the laboratory workflow of most in-house PCR assays.…”

mentioning

confidence: 99%

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

et al. 2020

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33In the race to contain SARS-CoV-2, efficient detection and triage of infected patients must 34 rely on rapid and reliable testing. In this work we performed the first evaluation of the 35 QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS) for SARS-CoV-2 detection. This 36 assay is the first rapid multiplex PCR (mPCR) assay including SARS-CoV-2 detection, and is 37 fully compatible with a non-PCR trained laboratory or point-of-care (POC) testing. 38 This evaluation was performed using 69 primary clinical samples (66 NPS, 1 BAL and 1 39 tracheal aspirate and 1 bronchial aspirate) comparing the SARS-CoV-2 detection with the 40 currently WHO recommended RT-PCR (WHO-PCR) workflow. Additionally, a comparative 41 limit of detection (LoD) assessment was performed between QIAstat-SARS and the WHO-42 PCR using a quantified clinical sample. Compatibility of sample pre-treatment for viral 43 neutralisation or viscous samples with the QIAstat-SARS system were also tested. 44 The QIAstat-Dx Respiratory SARS-CoV-2 Panel demonstrated a comparable sensitivity to the 45 WHO recommended assay with a limit of detection at 1000 copies/mL. The overall percent 46 agreement between QIAstat-Dx SARS and WHO-PCR on 69 clinical samples was 97% with a 47 sensitivity at 100% (40/40) and specificity at 93% (27/29). No cross reaction was 48 encountered for any other respiratory viruses or bacteria included in the panel. 49 The QIAstat-SARS rapid multiplex-PCR panel provides a highly sensitive, robust and accurate 50 assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR 51 trained laboratory or point-of-care testing, allowing innovative organisation. 52 on June 9, 2020 by guest http://jcm.asm.org/ Downloaded from 65 direct insertion of the NPS into the cartridge without additional manipulation. This 66 innovative design allows to test samples on demand in any laboratory, even not PCR trained, 67 or as a point-of-care (PoC) test with minimal training. The QIAstat-Dx SARS version of the 68 panel adds the detection of the SARS-CoV-2 in a previously unused amplification chamber, 69 thus without any change for sampling, extraction and PCR conditions for other respiratory 70 viruses' detection (4, 5). As for a few other rapid PCR assays available to date, results are 71 provided in about one hour, compared to labour-intensive three to four hours in-laboratory 72 workflow of most in-house PCR assays. The comprehensiveness and versatility of the kit can 73 potentially provide a useful tool, allowing innovative organisation to test patients suspected 74 of COVID-19 rapidly and with discrimination of other respiratory pathogens. This is of 75 on June 9, 2020 by guest http://jcm.asm.org/ Downloaded from Page 4 importance to accelerate isolation management, patient orientation and treatment 76 decisions. 77 Here, we report the first independent validation of this new commercial PCR assay for SARS-78 CoV-2 detection, using clinical samples both in laboratory and in the emergency department 79 as a point-of-care t...

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“…gyrA for fluoroquinone resistance [37]). While other highly multiplex PCR platforms such as BioFire [11] or StatDx [38] can detect drug resistance due to gain of gene, they typically lack the molecular specificity needed to identify resistance caused by point mutations. The ability to rapidly identify infections and prescribe effective antimicrobial therapies is especially needed to reduce the mortality and morbidity rate of nosocomial infections in the United States.…”

Section: Discussionmentioning

confidence: 99%

Donut PCR: a rapid, portable, multiplexed, and quantitative DNA detection platform with single-nucleotide specificity

Khodakov

Zhang

et al. 2020

Preprint

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Current platforms for molecular analysis of DNA markers are either limited in multiplexing (qPCR, isothermal amplification), turnaround time (microarrays, NGS), quantitation accuracy (isothermal amplification, microarray, nanopore sequencing), or specificity against single-nucleotide differences (microarrays, nanopore sequencing). Here, we present the Donut PCR platform that features high multiplexing, rapid turnaround times, single nucleotide discrimination, and precise quantitation of DNA targets in a portable, affordable, and battery-powered instrument using closed consumables that minimize contamination. We built a bread-board instrument prototype and three assays/chips to demonstrate the capabilities of Donut PCR: (1) a 9-plex mammal identification panel, (2) a 15-plex bacterial identification panel, and (3) a 30-plex human SNP genotyping assay. The limit of detection of the platform is under 10 genomic copies in under 30 minutes, and the quantitative dynamic range is at least 4 logs. We envision that this platform would be useful for a variety of applications where rapid and highly multiplexed nucleic acid detection is needed at the point of care.

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Multicenter evaluation of the QIAstat Respiratory Panel—A new rapid highly multiplexed PCR based assay for diagnosis of acute respiratory tract infections

Cited by 35 publications

References 22 publications

A case of an Infant with SARS‐CoV‐2 hepatitis early after liver transplantation

A case of an Infant with SARS‐CoV‐2 hepatitis early after liver transplantation

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

Donut PCR: a rapid, portable, multiplexed, and quantitative DNA detection platform with single-nucleotide specificity

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