Melting curve analysis reveals false-positive norovirus detection in a molecular syndromic panel
Background: Molecular syndromic panels can improve rapidity of results and ease clinical laboratory workflow, although caution has been raised for potential false-positive results. Upon implementation of a new panel for infectious diarrhea (BioFire FilmArray Gastrointestinal [GI] Panel, bioMerieux) in our clinical laboratory, a high number of stool samples with norovirus were detected. Objectives: To investigate positive percent agreement and the false-positive rate of norovirus detected by the multiplex Biofire GI panel compared to a singleplex commercial assay. Study design: From October 2023 to January 2024, all prospective stool samples with a positive norovirus result by BioFire had melting curves reviewed manually using the BioFire FilmArray Torch System. Stool samples further underwent testing by a supplementary real-time RT-PCR assay (Xpert Norovirus, Cepheid) for comparative analysis. Results: Of the 50 stool samples with norovirus detected by BioFire, 18 (36%) tested negative by Xpert (deemed "false-positives"). Melting curve analysis revealed nearly all of these samples had atypical melting curve morphologies for the "Noro-1" target on BioFire (16/18, 89%), which was statistically significant (Odds Ratio 173.2, 95% CI [22.2, 5326.9], p<0.0001). Stool samples with multiple pathogens including norovirus detected by BioFire were not more likely to produce false-positive norovirus results (Odds Ratio 1, 95% CI [0.3, 3.3], p=1). Conclusions: Although not described in the manufacturer's Instructions for Use, we propose routine manual review of melting curves for the BioFire GI panel prior to reporting, to avoid potential false-positive norovirus results..
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Preprint| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
bioRxiv.org - (2024) vom: 27. Feb. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Matic, Nancy [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| doi: |
10.1101/2024.02.23.24303102 |
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| PPN (Katalog-ID): |
XBI04264531X |
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| 520 | |a Background: Molecular syndromic panels can improve rapidity of results and ease clinical laboratory workflow, although caution has been raised for potential false-positive results. Upon implementation of a new panel for infectious diarrhea (BioFire FilmArray Gastrointestinal [GI] Panel, bioMerieux) in our clinical laboratory, a high number of stool samples with norovirus were detected. Objectives: To investigate positive percent agreement and the false-positive rate of norovirus detected by the multiplex Biofire GI panel compared to a singleplex commercial assay. Study design: From October 2023 to January 2024, all prospective stool samples with a positive norovirus result by BioFire had melting curves reviewed manually using the BioFire FilmArray Torch System. Stool samples further underwent testing by a supplementary real-time RT-PCR assay (Xpert Norovirus, Cepheid) for comparative analysis. Results: Of the 50 stool samples with norovirus detected by BioFire, 18 (36%) tested negative by Xpert (deemed "false-positives"). Melting curve analysis revealed nearly all of these samples had atypical melting curve morphologies for the "Noro-1" target on BioFire (16/18, 89%), which was statistically significant (Odds Ratio 173.2, 95% CI [22.2, 5326.9], p<0.0001). Stool samples with multiple pathogens including norovirus detected by BioFire were not more likely to produce false-positive norovirus results (Odds Ratio 1, 95% CI [0.3, 3.3], p=1). Conclusions: Although not described in the manufacturer's Instructions for Use, we propose routine manual review of melting curves for the BioFire GI panel prior to reporting, to avoid potential false-positive norovirus results. | ||
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| 700 | 1 | |a Young, Matthew |4 aut | |
| 700 | 1 | |a Jang, Willson |4 aut | |
| 700 | 1 | |a Bilawka, Jennifer |4 aut | |
| 700 | 1 | |a Gowland, Leah |4 aut | |
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| 700 | 1 | |a Leung, Victor |4 aut | |
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