Performance evaluation of direct fluorescent antibody, Focus Diagnostics Simplexa™ Flu A/B &amp; RSV and multi-parameter customized respiratory Taqman® array card in immunocompromised patients

Steensels, Deborah; Descheemaeker, Patrick; Curran, Martin D.; Jacobs, Frédérique; Denis, Olivier; Delforge, Marie-Luce; Montesinos, Isabel

doi:10.1016/j.jviromet.2017.03.013

Cited by 8 publications

(8 citation statements)

References 21 publications

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“…There are several commercially available real-time reverse transcriptase PCR (RT-PCR) assays currently approved by the Food and Drug Administration (FDA) for the detection of single or multiple respiratory pathogens (11). They vary in test format (e.g., random access or batched), throughput, and numbers of pathogens covered (7)(8)(9)(10)(12)(13)(14)(15)(16)(17)(18)(19). Among them, the Aries Flu A/B & RSV (Luminex Corp., Austin, TX) (15), Xpert Xpress Flu/RSV (Cepheid, Sunnyvale, CA) (13), and Cobas Flu A/B & RSV (Roche Molecular Systems, Pleasanton, CA) (14) assays are integrated nucleic acid extractionindependent devices that have recently received FDA clearance for simultaneous detection and identification of FluA, FluB, and RSV in nasopharyngeal swabs.…”

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confidence: 99%

Parallel Validation of Three Molecular Devices for Simultaneous Detection and Identification of Influenza A and B and Respiratory Syncytial Viruses

et al. 2018

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Rapid identification of respiratory pathogens, such as influenza virus A (FluA), influenza virus B (FluB), and respiratory syncytial virus (RSV), reduces unnecessary antimicrobial use and enhances infection control practice. We performed a comparative evaluation of three molecular methods: (i) the Aries Flu A/B & RSV, (ii) the Xpert Xpress Flu/RSV, and (iii) the Cobas Flu A/B & RSV assays. The clinical performances of the three methods were evaluated using 200 remnant nasopharyngeal swab (NPS) specimens against a combined reference standard. The limits of detection (LODs) were determined using FluA, FluB, and RSV control strains with known titers. The 95% LODs were between 1.702 and 0.0003 50% tissue culture infective dose (TCID), with no significant differences revealed among the three assays. Perfect qualitative detection agreement was obtained in the reproducibility study. The Cobas assay failed at the first run on 13 clinical specimens, resulting in an invalid rate of 6.5%. The sensitivities and specificities for all assays were 96.0 to 100.0% and 99.3 to 100% for all three viruses. For on-demand single-specimen and batched 12-specimen workflows, the test turnaround times were 115.5 and 128.8 min for the Aries assay (12 sample capacity), 34.2 and 44.2 min for the Xpress assay (16 sample capacity), and 21.0 and 254.4 min for the Cobas assay (one instrument), respectively. In summary, the Aries, Xpress, and Cobas Liat assays demonstrated excellent sensitivities and specificities for simultaneous detection and identification of FluA, FluB, and RSV from NPS specimens in cancer patients. Test turnaround time was significantly shorter on the Xpress when instrument scalability is unlimited.

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confidence: 99%

Parallel Validation of Three Molecular Devices for Simultaneous Detection and Identification of Influenza A and B and Respiratory Syncytial Viruses

et al. 2018

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“…24 The TaqMan array card (TAC) is a microfluidic card designed to automate several TaqMan qPCR assays per sample. Originally designed for gene expression experiments, TAC has been effectively repurposed for detection of large panels of pathogens, 25 with successful application to human faecal, 26 blood, 27 cerebrospinal fluid, 28 and naso pharyngeal 29 samples. Generally, the ability to efficiently detect large numbers of pathogens simultaneously is accompanied by a loss of sensitivity compared with standard qPCR, 30,31 although it is highly cost-effective compared with standard qPCR for the breadth of targets that can be detected.…”

Section: Implications Of All the Available Evidencementioning

confidence: 99%

Monitoring of diverse enteric pathogens across environmental and host reservoirs with TaqMan array cards and standard qPCR: a methodological comparison study

Lappan

Henry

Chown

et al. 2021

The Lancet Planetary Health

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Background Multiple bacteria, viruses, protists, and helminths cause enteric infections that greatly impact human health and wellbeing. These enteropathogens are transmited via several pathways through human, animal, and environmental reservoirs. Individual qPCR assays have been extensively used to detect enteropathogens within these types of samples, whereas the TaqMan array card (TAC), which allows simultaneous detection of multiple enteropathogens, has only previously been validated in human clinical samples.Methods In this methodological comparison study, we compared the performance of a custom 48-singleplex TAC relative to standard qPCR. We established the sensitivity and specificity of each method for the detection of eight enteric targets, by using spiked samples with varying levels of PCR inhibition. We then tested the prevalence and abundance of pathogens in wastewater from Melbourne (Australia), and human, animal, and environmental samples from informal settlements in Suva, Fiji using both TAC and qPCR.Findings Both methods exhibited similarly high specificity (TAC 100%, qPCR 94%), sensitivity (TAC 92%, qPCR 100%), and quantitation accuracy (TAC 91%, qPCR 99%) in non-inhibited sample matrices with spiked gene fragments. PCR inhibitors substantially affected detection via TAC, though this issue was alleviated by ten-fold sample dilution. Among samples from informal settlements, the two techniques performed similarly for detection (89% agreement) and quantitation (R² 0•82) for the eight enteropathogen targets. The TAC additionally included 38 other enteric targets, enabling detection of diverse faecal pathogens and extensive environmental contamination that would be prohibitively labour intensive to assay by standard qPCR.Interpretation The two techniques produced similar results across diverse sample types, with qPCR prioritising greater sensitivity and quantitation accuracy, and TAC trading small reductions in these for a cost-effective larger enteropathogen panel enabling a greater number of enteric pathogens to be analysed concurrently, which is beneficial given the abundance and variety of enteric pathogens in environments such as urban informal settlements. The ability to monitor multiple enteric pathogens across diverse reservoirs could allow better resolution of pathogen exposure pathways, and the design and monitoring of interventions to reduce pathogen load.

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“…Additionally, as an extraction and inhibition control a phoque distemper virus was used. Multiparameter testing for 35 respiratory pathogens was performed using an in house Taqman Array Card as described previously [5].…”

Section: Rt-pcr For Sars-cov-2 and Multiplex Testing For Other Respirmentioning

confidence: 99%

Comparison of four commercial SARS-CoV-2 IgG immuno-assays in RT-PCR negative patients with suspect CT findings

et al. 2020

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A subset of patients with Covid-19 presents with negative RT-PCR screening but suspect CT findings. Using four commercially available anti-SARS-CoV-2 IgG immuno-assays, we found this subset constituted 9.2% of all consecutively admitted outpatients with Covid-19 in our hospital. Clinical specificity for Covid-19 of some N protein-based immuno-assays was suboptimal, as positive results were observed in control patients with recent common human coronavirus, influenza B and adenovirus infections.

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Performance evaluation of direct fluorescent antibody, Focus Diagnostics Simplexa™ Flu A/B & RSV and multi-parameter customized respiratory Taqman® array card in immunocompromised patients

Cited by 8 publications

References 21 publications

Parallel Validation of Three Molecular Devices for Simultaneous Detection and Identification of Influenza A and B and Respiratory Syncytial Viruses

Parallel Validation of Three Molecular Devices for Simultaneous Detection and Identification of Influenza A and B and Respiratory Syncytial Viruses

Monitoring of diverse enteric pathogens across environmental and host reservoirs with TaqMan array cards and standard qPCR: a methodological comparison study

Comparison of four commercial SARS-CoV-2 IgG immuno-assays in RT-PCR negative patients with suspect CT findings

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