Multicenter performance evaluation of the simplexa bordetella direct kit in nasopharyngeal swab specimens

Siu Kei Chow; Sophie S Arbefeville; Bobby L. Boyanton; Emily M. Dault; James Dunn; Patricia Ferrieri; Wallace Greene; Morgan A. Pence; Joshua Otiso; Sandra Richter; Ted E. Schutzbank

doi:10.1128/JCM.01041-20

Multicenter performance evaluation of the simplexa bordetella direct kit in nasopharyngeal swab specimens

Siu Kei Chow, Sophie S Arbefeville, Bobby L. Boyanton, Emily M. Dault, James Dunn, Patricia Ferrieri, Wallace Greene, Morgan A. Pence, Joshua Otiso, Sandra Richter, Ted E. Schutzbank

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

Detection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.

Original language	English (US)
Article number	e01041-20
Journal	Journal of clinical microbiology
Volume	59
Issue number	1
DOIs	https://doi.org/10.1128/JCM.01041-20
State	Published - Jan 2021

Bibliographical note

Funding Information:
This study was supported by DiaSorin Molecular.

Funding Information:
This study was supported by DiaSorin Molecular. S.-K.C. thanks the microbiology team at MultiCare Health System for their technical support. P.F. and S.A. thank Ann Fickle and Elizabeth Thonen-Kerr from the University of Minnesota Medical Center and Fairview Health System Infectious Diseases Diagnostic Laboratory for their technical expertise. B.L.B. thanks Ann Prada at Beaumont Health for her technical assistance. T.E.S. thanks Tong Her at Ascension St. John Hospital for his technical assistance. S.R. has been an employee of bioM?rieux since 12 August 2019. When employed at Cleveland Clinic, she received research funding from bioM?rieux, BD Diagnostics, Roche, DiaSorin, Accelerate, and Affinity Biosensors. All other authors have no conflict.

Publisher Copyright:
Copyright © 2020 American Society for Microbiology. All Rights Reserved.

Keywords

Bordetella species
PCR
Turnaround time
Whooping cough

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10.1128/JCM.01041-20

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title = "Multicenter performance evaluation of the simplexa bordetella direct kit in nasopharyngeal swab specimens",

abstract = "Detection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.",

keywords = "Bordetella species, PCR, Turnaround time, Whooping cough",

author = "Chow, {Siu Kei} and Arbefeville, {Sophie S} and Boyanton, {Bobby L.} and Dault, {Emily M.} and James Dunn and Patricia Ferrieri and Wallace Greene and Pence, {Morgan A.} and Joshua Otiso and Sandra Richter and Schutzbank, {Ted E.}",

note = "Funding Information: This study was supported by DiaSorin Molecular. Funding Information: This study was supported by DiaSorin Molecular. S.-K.C. thanks the microbiology team at MultiCare Health System for their technical support. P.F. and S.A. thank Ann Fickle and Elizabeth Thonen-Kerr from the University of Minnesota Medical Center and Fairview Health System Infectious Diseases Diagnostic Laboratory for their technical expertise. B.L.B. thanks Ann Prada at Beaumont Health for her technical assistance. T.E.S. thanks Tong Her at Ascension St. John Hospital for his technical assistance. S.R. has been an employee of bioM?rieux since 12 August 2019. When employed at Cleveland Clinic, she received research funding from bioM?rieux, BD Diagnostics, Roche, DiaSorin, Accelerate, and Affinity Biosensors. All other authors have no conflict. Publisher Copyright: Copyright {\textcopyright} 2020 American Society for Microbiology. All Rights Reserved.",

year = "2021",

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doi = "10.1128/JCM.01041-20",

language = "English (US)",

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AU - Chow, Siu Kei

AU - Arbefeville, Sophie S

AU - Boyanton, Bobby L.

AU - Dault, Emily M.

AU - Dunn, James

AU - Ferrieri, Patricia

AU - Greene, Wallace

AU - Pence, Morgan A.

AU - Otiso, Joshua

AU - Richter, Sandra

AU - Schutzbank, Ted E.

N1 - Funding Information: This study was supported by DiaSorin Molecular. Funding Information: This study was supported by DiaSorin Molecular. S.-K.C. thanks the microbiology team at MultiCare Health System for their technical support. P.F. and S.A. thank Ann Fickle and Elizabeth Thonen-Kerr from the University of Minnesota Medical Center and Fairview Health System Infectious Diseases Diagnostic Laboratory for their technical expertise. B.L.B. thanks Ann Prada at Beaumont Health for her technical assistance. T.E.S. thanks Tong Her at Ascension St. John Hospital for his technical assistance. S.R. has been an employee of bioM?rieux since 12 August 2019. When employed at Cleveland Clinic, she received research funding from bioM?rieux, BD Diagnostics, Roche, DiaSorin, Accelerate, and Affinity Biosensors. All other authors have no conflict. Publisher Copyright: Copyright © 2020 American Society for Microbiology. All Rights Reserved.

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N2 - Detection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.

AB - Detection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.

KW - Bordetella species

KW - PCR

KW - Turnaround time

KW - Whooping cough

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Multicenter performance evaluation of the simplexa bordetella direct kit in nasopharyngeal swab specimens

Abstract

Bibliographical note

Keywords

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