Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test

Mostafa, Heba H.; Lamson, Daryl M.; Uhteg, Katharine; Geahr, Melissa; Gluck, Linda; Cardenas, Jessica N Brazelton de; Morehead, Elizabeth; Forman, Michael; Carroll, Karen C.; Hayden, Randall T.; George, Kirsten St.

doi:10.1016/j.jcv.2020.104583

Cited by 22 publications

(16 citation statements)

References 27 publications

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“…In response to the COVID-19 global pandemic, a growing number of molecular diagnostic assays have become commercially available; assays differ in detection targets as well as analytical sensitivity, and most demonstrate high specificity ( 11 – 29 ). Variables that contribute to assay performance include the type of specimen examined, the time of specimen collection in relation to the course of illness, as well as the adequacy of specimen collection ( 30 – 34 ).…”

Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

et al. 2021

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With the approach of respiratory virus season in the Northern Hemisphere, clinical microbiology and public health laboratories will need rapid diagnostic assays to distinguish SARS-CoV-2 from influenza and respiratory syncytial virus (RSV) infections for diagnosis and surveillance. In this study, the clinical performance of the Xpert® Xpress SARS-CoV-2/Flu/RSV test (Cepheid, Sunnyvale, CA, USA) for nasopharyngeal swab specimens was evaluated in four centers: Johns Hopkins Medical Microbiology Laboratory, Northwell Health Laboratories, NYC Public Health Laboratory, and Los Angeles County/University of Southern California (LAC+USC) Medical Center. A total of 319 nasopharyngeal swab specimens, positive for SARS-CoV-2 (n = 75), influenza A (n = 65), influenza B (n = 50), RSV (n = 38), or negative (n = 91) by the standard of care nucleic acid amplification tests at each site were tested using the Cepheid panel test. The overall positive percent agreement for the SARS-CoV-2 target was 98.7% (n= 74/75) and the negative agreement was 100% (n= 91) with all other analytes showing 100% total agreement (n= 153). Standard of care tests to which the Cepheid panel was compared included the Cepheid Xpert Xpress SARS-CoV-2, Cepheid Xpert Xpress Flu/RSV, the GenMark ePlex respiratory panel, the BioFire Respiratory panels 2.1 and v1.7, the DiaSorin Simplexa COVID-19 Direct, and the Hologic Panther Fusion SARS-CoV-2 assays. The Xpert Xpress SARS-CoV-2/Flu/RSV test showed high sensitivity and accuracy for all analytes included in the test. This test will provide a valuable clinical diagnostic and public health solution for detecting and differentiating SARS-CoV-2, influenza A and B, and RSV infections during the current respiratory virus season.

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Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

et al. 2021

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“…Unprecedented demand for SARS-CoV-2 diagnostics led to development of a range of molecular assays designed for analyzers with high sample throughput allowing significant scaling up due to the fully automated sample-to-result solution. At present at least six high-throughput SARS-CoV-2 RNA assays are available: cobas SARS-CoV-2 4-11 , Alinity m SARS-CoV-2 20 , Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2 (Hologic, San Diego, CA, USA) 5 , 8 , 24 , 25 , 26 , 27 , NeuMoDx SARS-CoV-2 (NeuMoDx Molecular, Ann Arbor, MI, USA) 28 , 29 , and GeneXpert Infinity SARS-CoV-2 (Cepheid, Sunnyvale, CA, USA). Although several evaluations of these assays were published, in addition to present study only a single head-to-head comparison of two SARS-CoV-2 high-throughput assays was identified.…”

Section: Discussionmentioning

confidence: 99%

Real-Life Head-to-Head Comparison of Performance of Two High-Throughput Automated Assays for the Detection of SARS-CoV-2 RNA in Nasopharyngeal Swabs

Kogoj

Kmetič

Valenčak

et al. 2021

The Journal of Molecular Diagnostics

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“…Nasopharyngeal samples were tested by RT-PCR using either the Cobas ® SARS-CoV-2 (Roche, Switzerland) on a Cobas ® 6800 system [ 11 ] or the NeuMoDx ® SARS-CoV-2 Assay (QIAgen, Germany) on a NeuMoDx ® 288 system [ 12 ]. Cycle threshold (Ct) values of the ORF1ab and N targets were used as a proxy for viral load for the Cobas and the NeuMoDx assay, respectively.…”

Section: Methodsmentioning

confidence: 99%

Emergence of E484K Mutation Following Bamlanivimab Monotherapy among High-Risk Patients Infected with the Alpha Variant of SARS-CoV-2

Peiffer-Smadja

Bridier‐Nahmias

Ferré

et al. 2021

Viruses

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An Emergency Use Authorization was issued in the United States and in Europe for a monoclonal antibody monotherapy to prevent severe COVID-19 in high-risk patients. This study aimed to assess the risk of emergence of mutations following treatment with a single monoclonal antibody. Bamlanivimab was administered at a single dose of 700 mg in a one-hour IV injection in a referral center for the management of COVID-19 in France. Patients were closely monitored clinically and virologically with nasopharyngeal RT-PCR and viral whole genome sequencing. Six patients were treated for a nosocomial SARS-CoV-2 infection, all males, with a median age of 65 years and multiple comorbidities. All patients were infected with a B.1.1.7 variant, which was the most frequent variant in France at the time, and no patients had E484 mutations at baseline. Bamlanivimab was infused in the six patients within 4 days of the COVID-19 diagnosis. Four patients had a favorable outcome, one died of complications unrelated to COVID-19 or bamlanivimab, and one kidney transplant patient treated with belatacept died from severe COVID-19 more than 40 days after bamlanivimab administration. Virologically, four patients cleared nasopharyngeal viral shedding within one month after infusion, while two presented prolonged viral excretion for more than 40 days. The emergence of E484K mutants was observed in five out of six patients, and the last patient presented a Q496R mutation potentially associated with resistance. CONCLUSIONS: These results show a high risk of emergence of resistance mutants in COVID-19 patients treated with monoclonal antibody monotherapy.

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Multicenter evaluation of the NeuMoDx™ SARS-CoV-2 Test

Cited by 22 publications

References 27 publications

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Real-Life Head-to-Head Comparison of Performance of Two High-Throughput Automated Assays for the Detection of SARS-CoV-2 RNA in Nasopharyngeal Swabs

Emergence of E484K Mutation Following Bamlanivimab Monotherapy among High-Risk Patients Infected with the Alpha Variant of SARS-CoV-2

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