Multicenter Performance Evaluation of the Revogene® GBS DS Real-Time PCR Assay for Group B Streptococcus Detection During Labor
© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG..
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. Sept., Seite 611-620 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
d'Otreppe, Stéphanie [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 18.08.2023 Date Revised 09.09.2023 published: Print-Electronic Citation Status MEDLINE |
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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): |
NLM359714234 |
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| 500 | |a Date Revised 09.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG. | ||
| 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Lefèvre, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Meex, Cécile |e verfasserin |4 aut | |
| 700 | 1 | |a Devey, Anaïs |e verfasserin |4 aut | |
| 700 | 1 | |a Sacheli, Rosalie |e verfasserin |4 aut | |
| 700 | 1 | |a Gerard, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Melin, Pierrette |e verfasserin |4 aut | |
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