Multicenter Performance Evaluation of the $ Revogene^{®} $ GBS DS Real-Time PCR Assay for Group B Streptococcus Detection During Labor
Purpose This study aimed to evaluate the performance and ease of use of the $ Revogene^{®} $ GBS DS PCR assay for the intrapartum detection of Group B Streptococcus (GBS) colonization, as compared with intrapartum culture and antenatal culture-based screening. Methods Between April and August 2019, 398 women who gave birth in one of the three maternities participating in this study agreed to the collection of a vaginal swab when they arrived in the labor ward. The samples were immediately sent to the adjacent laboratory where they were discharged into the buffer provided with the $ Revogene^{®} $ GBS DS assay. Part of the buffer was used to perform the $ Revogene^{®} $ GBS DS test, and part of the same buffer was used for GBS culture. Results The $ Revogene^{®} $ GBS DS assay provided a valid result in less than 70 min for 356 (89%) women. The sensitivity of the test was 85.7% (66.4–95.3%). The specificity of the test was 99.1% (97.3–99.8%). The positive predictive value was 88.9% (69.7–97.1%). The negative predictive value was 98.9% (96.9–99.6%). Conclusion The easy-to-use $ Revogene^{®} $ GBS DS assay provides a valuable tool for the detection of GBS colonization at the beginning of labor. The sensitivity and turn-around time are adequate. The high number of invalid results needs to be addressed before the $ Revogene^{®} $ GBS DS test can be expected to replace the current screening-based approach..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
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| Enthalten in: |
Molecular diagnosis & therapy - 27(2023), 5 vom: 20. Juli, Seite 611-620 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
d’Otreppe, Stéphanie [VerfasserIn] |
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| Links: |
Volltext [lizenzpflichtig] |
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| Anmerkungen: |
© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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| doi: |
10.1007/s40291-023-00660-3 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
SPR052780902 |
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| 520 | |a Purpose This study aimed to evaluate the performance and ease of use of the $ Revogene^{®} $ GBS DS PCR assay for the intrapartum detection of Group B Streptococcus (GBS) colonization, as compared with intrapartum culture and antenatal culture-based screening. Methods Between April and August 2019, 398 women who gave birth in one of the three maternities participating in this study agreed to the collection of a vaginal swab when they arrived in the labor ward. The samples were immediately sent to the adjacent laboratory where they were discharged into the buffer provided with the $ Revogene^{®} $ GBS DS assay. Part of the buffer was used to perform the $ Revogene^{®} $ GBS DS test, and part of the same buffer was used for GBS culture. Results The $ Revogene^{®} $ GBS DS assay provided a valid result in less than 70 min for 356 (89%) women. The sensitivity of the test was 85.7% (66.4–95.3%). The specificity of the test was 99.1% (97.3–99.8%). The positive predictive value was 88.9% (69.7–97.1%). The negative predictive value was 98.9% (96.9–99.6%). Conclusion The easy-to-use $ Revogene^{®} $ GBS DS assay provides a valuable tool for the detection of GBS colonization at the beginning of labor. The sensitivity and turn-around time are adequate. The high number of invalid results needs to be addressed before the $ Revogene^{®} $ GBS DS test can be expected to replace the current screening-based approach. | ||
| 700 | 1 | |a Lefèvre, Philippe |4 aut | |
| 700 | 1 | |a Meex, Cécile |0 (orcid)0000-0002-2499-2038 |4 aut | |
| 700 | 1 | |a Devey, Anaïs |0 (orcid)0000-0001-9628-3954 |4 aut | |
| 700 | 1 | |a Sacheli, Rosalie |0 (orcid)0000-0002-3922-324X |4 aut | |
| 700 | 1 | |a Gerard, Martin |4 aut | |
| 700 | 1 | |a Melin, Pierrette |0 (orcid)0000-0002-2159-5774 |4 aut | |
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