Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2
Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Wirden, Marc [verfasserIn] Feghoul, Linda [verfasserIn] Bertine, Mélanie [verfasserIn] Nere, Marie-Laure [verfasserIn] Le Hingrat, Quentin [verfasserIn] Abdi, Basma [verfasserIn] Boutolleau, David [verfasserIn] Ferre, Valentine Marie [verfasserIn] Jary, Aude [verfasserIn] Delaugerre, Constance [verfasserIn] Marcelin, Anne-Genevieve [verfasserIn] Descamps, Diane [verfasserIn] Legoff, Jérôme [verfasserIn] Visseaux, Benoit [verfasserIn] Chaix, Marie-Laure [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Journal of clinical virology - Amsterdam [u.a.] : Elsevier Science, 1993, 130 |
|---|---|
| Übergeordnetes Werk: |
volume:130 |
| DOI / URN: |
10.1016/j.jcv.2020.104573 |
|---|
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ELV00467314X |
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| 100 | 1 | |a Wirden, Marc |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
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| 520 | |a Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. | ||
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a RT-PCR | |
| 650 | 4 | |a Altona | |
| 650 | 4 | |a Cobas 6800 | |
| 700 | 1 | |a Feghoul, Linda |e verfasserin |4 aut | |
| 700 | 1 | |a Bertine, Mélanie |e verfasserin |4 aut | |
| 700 | 1 | |a Nere, Marie-Laure |e verfasserin |4 aut | |
| 700 | 1 | |a Le Hingrat, Quentin |e verfasserin |0 (orcid)0000-0001-9017-4941 |4 aut | |
| 700 | 1 | |a Abdi, Basma |e verfasserin |4 aut | |
| 700 | 1 | |a Boutolleau, David |e verfasserin |4 aut | |
| 700 | 1 | |a Ferre, Valentine Marie |e verfasserin |4 aut | |
| 700 | 1 | |a Jary, Aude |e verfasserin |0 (orcid)0000-0002-1952-6729 |4 aut | |
| 700 | 1 | |a Delaugerre, Constance |e verfasserin |4 aut | |
| 700 | 1 | |a Marcelin, Anne-Genevieve |e verfasserin |4 aut | |
| 700 | 1 | |a Descamps, Diane |e verfasserin |4 aut | |
| 700 | 1 | |a Legoff, Jérôme |e verfasserin |4 aut | |
| 700 | 1 | |a Visseaux, Benoit |e verfasserin |0 (orcid)0000-0002-9279-5538 |4 aut | |
| 700 | 1 | |a Chaix, Marie-Laure |e verfasserin |4 aut | |
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10.1016/j.jcv.2020.104573 doi (DE-627)ELV00467314X (ELSEVIER)S1386-6532(20)30315-2 DE-627 ger DE-627 rda eng 610 DE-600 44.43 bkl Wirden, Marc verfasserin aut Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 Feghoul, Linda verfasserin aut Bertine, Mélanie verfasserin aut Nere, Marie-Laure verfasserin aut Le Hingrat, Quentin verfasserin (orcid)0000-0001-9017-4941 aut Abdi, Basma verfasserin aut Boutolleau, David verfasserin aut Ferre, Valentine Marie verfasserin aut Jary, Aude verfasserin (orcid)0000-0002-1952-6729 aut Delaugerre, Constance verfasserin aut Marcelin, Anne-Genevieve verfasserin aut Descamps, Diane verfasserin aut Legoff, Jérôme verfasserin aut Visseaux, Benoit verfasserin (orcid)0000-0002-9279-5538 aut Chaix, Marie-Laure verfasserin aut Enthalten in Journal of clinical virology Amsterdam [u.a.] : Elsevier Science, 1993 130 Online-Ressource (DE-627)306654539 (DE-600)1499932-8 (DE-576)121465446 1873-5967 nnns volume:130 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_2004 GBV_ILN_2336 44.43 Medizinische Mikrobiologie AR 130 |
| spelling |
10.1016/j.jcv.2020.104573 doi (DE-627)ELV00467314X (ELSEVIER)S1386-6532(20)30315-2 DE-627 ger DE-627 rda eng 610 DE-600 44.43 bkl Wirden, Marc verfasserin aut Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 Feghoul, Linda verfasserin aut Bertine, Mélanie verfasserin aut Nere, Marie-Laure verfasserin aut Le Hingrat, Quentin verfasserin (orcid)0000-0001-9017-4941 aut Abdi, Basma verfasserin aut Boutolleau, David verfasserin aut Ferre, Valentine Marie verfasserin aut Jary, Aude verfasserin (orcid)0000-0002-1952-6729 aut Delaugerre, Constance verfasserin aut Marcelin, Anne-Genevieve verfasserin aut Descamps, Diane verfasserin aut Legoff, Jérôme verfasserin aut Visseaux, Benoit verfasserin (orcid)0000-0002-9279-5538 aut Chaix, Marie-Laure verfasserin aut Enthalten in Journal of clinical virology Amsterdam [u.a.] : Elsevier Science, 1993 130 Online-Ressource (DE-627)306654539 (DE-600)1499932-8 (DE-576)121465446 1873-5967 nnns volume:130 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_2004 GBV_ILN_2336 44.43 Medizinische Mikrobiologie AR 130 |
| allfields_unstemmed |
10.1016/j.jcv.2020.104573 doi (DE-627)ELV00467314X (ELSEVIER)S1386-6532(20)30315-2 DE-627 ger DE-627 rda eng 610 DE-600 44.43 bkl Wirden, Marc verfasserin aut Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 Feghoul, Linda verfasserin aut Bertine, Mélanie verfasserin aut Nere, Marie-Laure verfasserin aut Le Hingrat, Quentin verfasserin (orcid)0000-0001-9017-4941 aut Abdi, Basma verfasserin aut Boutolleau, David verfasserin aut Ferre, Valentine Marie verfasserin aut Jary, Aude verfasserin (orcid)0000-0002-1952-6729 aut Delaugerre, Constance verfasserin aut Marcelin, Anne-Genevieve verfasserin aut Descamps, Diane verfasserin aut Legoff, Jérôme verfasserin aut Visseaux, Benoit verfasserin (orcid)0000-0002-9279-5538 aut Chaix, Marie-Laure verfasserin aut Enthalten in Journal of clinical virology Amsterdam [u.a.] : Elsevier Science, 1993 130 Online-Ressource (DE-627)306654539 (DE-600)1499932-8 (DE-576)121465446 1873-5967 nnns volume:130 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_2004 GBV_ILN_2336 44.43 Medizinische Mikrobiologie AR 130 |
| allfieldsGer |
10.1016/j.jcv.2020.104573 doi (DE-627)ELV00467314X (ELSEVIER)S1386-6532(20)30315-2 DE-627 ger DE-627 rda eng 610 DE-600 44.43 bkl Wirden, Marc verfasserin aut Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 Feghoul, Linda verfasserin aut Bertine, Mélanie verfasserin aut Nere, Marie-Laure verfasserin aut Le Hingrat, Quentin verfasserin (orcid)0000-0001-9017-4941 aut Abdi, Basma verfasserin aut Boutolleau, David verfasserin aut Ferre, Valentine Marie verfasserin aut Jary, Aude verfasserin (orcid)0000-0002-1952-6729 aut Delaugerre, Constance verfasserin aut Marcelin, Anne-Genevieve verfasserin aut Descamps, Diane verfasserin aut Legoff, Jérôme verfasserin aut Visseaux, Benoit verfasserin (orcid)0000-0002-9279-5538 aut Chaix, Marie-Laure verfasserin aut Enthalten in Journal of clinical virology Amsterdam [u.a.] : Elsevier Science, 1993 130 Online-Ressource (DE-627)306654539 (DE-600)1499932-8 (DE-576)121465446 1873-5967 nnns volume:130 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_2004 GBV_ILN_2336 44.43 Medizinische Mikrobiologie AR 130 |
| allfieldsSound |
10.1016/j.jcv.2020.104573 doi (DE-627)ELV00467314X (ELSEVIER)S1386-6532(20)30315-2 DE-627 ger DE-627 rda eng 610 DE-600 44.43 bkl Wirden, Marc verfasserin aut Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 Feghoul, Linda verfasserin aut Bertine, Mélanie verfasserin aut Nere, Marie-Laure verfasserin aut Le Hingrat, Quentin verfasserin (orcid)0000-0001-9017-4941 aut Abdi, Basma verfasserin aut Boutolleau, David verfasserin aut Ferre, Valentine Marie verfasserin aut Jary, Aude verfasserin (orcid)0000-0002-1952-6729 aut Delaugerre, Constance verfasserin aut Marcelin, Anne-Genevieve verfasserin aut Descamps, Diane verfasserin aut Legoff, Jérôme verfasserin aut Visseaux, Benoit verfasserin (orcid)0000-0002-9279-5538 aut Chaix, Marie-Laure verfasserin aut Enthalten in Journal of clinical virology Amsterdam [u.a.] : Elsevier Science, 1993 130 Online-Ressource (DE-627)306654539 (DE-600)1499932-8 (DE-576)121465446 1873-5967 nnns volume:130 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_2004 GBV_ILN_2336 44.43 Medizinische Mikrobiologie AR 130 |
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The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. 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Wirden, Marc |
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Wirden, Marc ddc 610 bkl 44.43 misc COVID-19 misc SARS-CoV-2 misc RT-PCR misc Altona misc Cobas 6800 Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
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610 DE-600 44.43 bkl Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 COVID-19 SARS-CoV-2 RT-PCR Altona Cobas 6800 |
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Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
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Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
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Wirden, Marc Feghoul, Linda Bertine, Mélanie Nere, Marie-Laure Le Hingrat, Quentin Abdi, Basma Boutolleau, David Ferre, Valentine Marie Jary, Aude Delaugerre, Constance Marcelin, Anne-Genevieve Descamps, Diane Legoff, Jérôme Visseaux, Benoit Chaix, Marie-Laure |
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10.1016/j.jcv.2020.104573 |
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multicenter comparison of the cobas 6800 system with the realstar rt-pcr kit for the detection of sars-cov-2 |
| title_auth |
Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
| abstract |
Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. |
| abstractGer |
Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. |
| abstract_unstemmed |
Background: RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).Methods: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).Results: Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.Conclusions: In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays. |
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Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 |
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Feghoul, Linda Bertine, Mélanie Nere, Marie-Laure Le Hingrat, Quentin Abdi, Basma Boutolleau, David Ferre, Valentine Marie Jary, Aude Delaugerre, Constance Marcelin, Anne-Genevieve Descamps, Diane Legoff, Jérôme Visseaux, Benoit Chaix, Marie-Laure |
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Feghoul, Linda Bertine, Mélanie Nere, Marie-Laure Le Hingrat, Quentin Abdi, Basma Boutolleau, David Ferre, Valentine Marie Jary, Aude Delaugerre, Constance Marcelin, Anne-Genevieve Descamps, Diane Legoff, Jérôme Visseaux, Benoit Chaix, Marie-Laure |
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