Performance Assessment of a Rapid Molecular Respiratory Syncytial Virus Point-of-Care Test : A Prospective Community Study in Older Adults
© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America..
BACKGROUND: Respiratory syncytial virus (RSV) causes a substantial burden in older adults. Viral load in RSV-infected adults is generally lower compared to young children, which could result in suboptimal sensitivity of RSV diagnostics. Although the Xpert® Xpress Flu/RSV assay has been used in routine clinical care, its sensitivity to diagnose RSV infection in older adults is largely unknown. We aimed to compare the performance of the Xpert® Xpress Flu/RSV assay with real-time reverse-transcription polymerase chain reaction (RT-PCR) in home-dwelling older adults (≥60 years of age).
METHODS: Nasopharyngeal swabs were tested with Xpert® Xpress Flu/RSV and compared to RSV RT-PCR in older adults with acute respiratory tract infections with different levels of disease severity.
RESULTS: We studied 758 respiratory samples from 561 older adults from 2 consecutive RSV seasons. Thirty-five (4.6%) samples tested positive for RSV by at least 1 of the assays, of which 2 samples were negative by Xpert® Xpress Flu/RSV and 3 samples by real-time RT-PCR. The positive percentage agreement (PPA) was 90.9% (95% confidence interval [CI], 76.4%-96.8%) and negative percentage agreement was 99.7% (95% CI, 99.0%-99.9%). Viral loads were low (≤103 copies/mL or cycle threshold value ≥34) in all cases with discordant results for the 2 assays.
CONCLUSIONS: The PPA of Xpert® Xpress Flu/RSV compared to routine RT-PCR is high for RSV detection in home-dwelling older adults. The assay is fast and easy to use at the point of care.
CLINICAL TRIALS REGISTRATION: NCT03621930.
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
2022 |
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Erschienen: |
2022 |
Enthalten in: |
Zur Gesamtaufnahme - volume:226 |
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Enthalten in: |
The Journal of infectious diseases - 226(2022), Suppl 1 vom: 12. Aug., Seite S63-S70 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Zuurbier, Roy P [VerfasserIn] |
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Links: |
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Themen: |
Diagnosis |
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Anmerkungen: |
Date Completed 16.08.2022 Date Revised 21.08.2022 published: Print ClinicalTrials.gov: NCT03621930 Citation Status MEDLINE |
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doi: |
10.1093/infdis/jiab600 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM336673108 |
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500 | |a Citation Status MEDLINE | ||
520 | |a © The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. | ||
520 | |a BACKGROUND: Respiratory syncytial virus (RSV) causes a substantial burden in older adults. Viral load in RSV-infected adults is generally lower compared to young children, which could result in suboptimal sensitivity of RSV diagnostics. Although the Xpert® Xpress Flu/RSV assay has been used in routine clinical care, its sensitivity to diagnose RSV infection in older adults is largely unknown. We aimed to compare the performance of the Xpert® Xpress Flu/RSV assay with real-time reverse-transcription polymerase chain reaction (RT-PCR) in home-dwelling older adults (≥60 years of age) | ||
520 | |a METHODS: Nasopharyngeal swabs were tested with Xpert® Xpress Flu/RSV and compared to RSV RT-PCR in older adults with acute respiratory tract infections with different levels of disease severity | ||
520 | |a RESULTS: We studied 758 respiratory samples from 561 older adults from 2 consecutive RSV seasons. Thirty-five (4.6%) samples tested positive for RSV by at least 1 of the assays, of which 2 samples were negative by Xpert® Xpress Flu/RSV and 3 samples by real-time RT-PCR. The positive percentage agreement (PPA) was 90.9% (95% confidence interval [CI], 76.4%-96.8%) and negative percentage agreement was 99.7% (95% CI, 99.0%-99.9%). Viral loads were low (≤103 copies/mL or cycle threshold value ≥34) in all cases with discordant results for the 2 assays | ||
520 | |a CONCLUSIONS: The PPA of Xpert® Xpress Flu/RSV compared to routine RT-PCR is high for RSV detection in home-dwelling older adults. The assay is fast and easy to use at the point of care | ||
520 | |a CLINICAL TRIALS REGISTRATION: NCT03621930 | ||
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700 | 1 | |a Leach, Amanda |e investigator |4 oth | |
700 | 1 | |a Nair, Harish |e investigator |4 oth | |
700 | 1 | |a Campbell, Harry |e investigator |4 oth | |
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