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Session Type: ePosters
Session Title: ePosters
Authors(s): M. Robertson (1), V. Mangale (1), A. Crawford (1), B. Mohajer (2), K. Clyde (2), O. Aceves (2), M. Gandhi (2), M. Schumaker (2), X. Wang (2)
Authors Affiliations(s): (1) Quantigen BioSciences, United States, (2) Thermo Fisher Scientific, United States
Background:
The TaqPath™ COVID-19 Combo CE-IVD Kit targets three SARS-CoV-2 genes (ORF1ab, N, S), whereas the Lyra® SARS-CoV-2 Assay targets a single SARS-CoV-2 gene (ORF1ab). Both assays use an automated RNA extraction protocol and bacteriophage MS2 as an exogenous process control. In this study, we compared clinical performance of the two above-mentioned RT-qPCR diagnostic tests with clinical nasopharyngeal swabs, using the Roche SARS-CoV-2 assay to resolve discordant results.
Methods:A retrospective study was conducted on residual nasopharyngeal specimens at Quantigen BioSciences in January 2021. A total of 240 samples were selected based upon results generated by an EUA-cleared test as part of routine clinical testing. Residual samples stored at -80°C were blinded and aliquoted at an independent site and shipped back to the testing site for parallel testing. Automated, magnetic-bead based RNA extraction was conducted according to each assay’s EUA-approved protocol. RT-qPCR with both assays was performed on an Applied BioSystems 7500 Fast Dx Real-Time PCR instrument. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Discordant samples were evaluated using the Roche SARS-CoV-2 assay on a cobas® 6800 system at an independent facility (Poplar Healthcare, TN, USA).
Results:Of the 240 samples, 14 samples were excluded from the cohort due to invalid/non-interpretable results generated by the Lyra® assay (12 samples) and inconclusive results generated by the TaqPath assay (2 samples). The final study cohort consisted of 226 samples (107 positives and 119 negatives). The PPA between the two assays was 93.5% and the NPA was 93.3%, with a total of 15 discordant results between the two assays. Of the 15 discordant samples, 3 samples did not produce conclusive results with the Roche SARS-CoV-2 assay. Of the remaining 12 discordant samples, arbitration was evenly split, with the resolver test agreeing with 50% of the discordant samples (6/12 samples each) for each assay.
Conclusions:Overall, a strong concordance was observed between the TaqPath™ COVID-19 Combo CE-IVD Kit and the Lyra® SARS-CoV-2 Assay. Arbitration testing using an independent assay generated an even split between the two assays.
Keyword(s): TaqPath, Lyra, SARS-CoV-2COI Stock Options: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Robertson (1), V. Mangale (1), A. Crawford (1), B. Mohajer (2), K. Clyde (2), O. Aceves (2), M. Gandhi (2), M. Schumaker (2), X. Wang (2)
Authors Affiliations(s): (1) Quantigen BioSciences, United States, (2) Thermo Fisher Scientific, United States
Background:
The TaqPath™ COVID-19 Combo CE-IVD Kit targets three SARS-CoV-2 genes (ORF1ab, N, S), whereas the Lyra® SARS-CoV-2 Assay targets a single SARS-CoV-2 gene (ORF1ab). Both assays use an automated RNA extraction protocol and bacteriophage MS2 as an exogenous process control. In this study, we compared clinical performance of the two above-mentioned RT-qPCR diagnostic tests with clinical nasopharyngeal swabs, using the Roche SARS-CoV-2 assay to resolve discordant results.
Methods:A retrospective study was conducted on residual nasopharyngeal specimens at Quantigen BioSciences in January 2021. A total of 240 samples were selected based upon results generated by an EUA-cleared test as part of routine clinical testing. Residual samples stored at -80°C were blinded and aliquoted at an independent site and shipped back to the testing site for parallel testing. Automated, magnetic-bead based RNA extraction was conducted according to each assay’s EUA-approved protocol. RT-qPCR with both assays was performed on an Applied BioSystems 7500 Fast Dx Real-Time PCR instrument. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Discordant samples were evaluated using the Roche SARS-CoV-2 assay on a cobas® 6800 system at an independent facility (Poplar Healthcare, TN, USA).
Results:Of the 240 samples, 14 samples were excluded from the cohort due to invalid/non-interpretable results generated by the Lyra® assay (12 samples) and inconclusive results generated by the TaqPath assay (2 samples). The final study cohort consisted of 226 samples (107 positives and 119 negatives). The PPA between the two assays was 93.5% and the NPA was 93.3%, with a total of 15 discordant results between the two assays. Of the 15 discordant samples, 3 samples did not produce conclusive results with the Roche SARS-CoV-2 assay. Of the remaining 12 discordant samples, arbitration was evenly split, with the resolver test agreeing with 50% of the discordant samples (6/12 samples each) for each assay.
Conclusions:Overall, a strong concordance was observed between the TaqPath™ COVID-19 Combo CE-IVD Kit and the Lyra® SARS-CoV-2 Assay. Arbitration testing using an independent assay generated an even split between the two assays.
Keyword(s): TaqPath, Lyra, SARS-CoV-2COI Stock Options: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Robertson (1), V. Mangale (1), A. Crawford (1), B. Mohajer (2), K. Clyde (2), O. Aceves (2), M. Gandhi (2), M. Schumaker (2), X. Wang (2)
Authors Affiliations(s): (1) Quantigen BioSciences, United States, (2) Thermo Fisher Scientific, United States
Background:
The TaqPath™ COVID-19 Combo CE-IVD Kit targets three SARS-CoV-2 genes (ORF1ab, N, S), whereas the Lyra® SARS-CoV-2 Assay targets a single SARS-CoV-2 gene (ORF1ab). Both assays use an automated RNA extraction protocol and bacteriophage MS2 as an exogenous process control. In this study, we compared clinical performance of the two above-mentioned RT-qPCR diagnostic tests with clinical nasopharyngeal swabs, using the Roche SARS-CoV-2 assay to resolve discordant results.
Methods:A retrospective study was conducted on residual nasopharyngeal specimens at Quantigen BioSciences in January 2021. A total of 240 samples were selected based upon results generated by an EUA-cleared test as part of routine clinical testing. Residual samples stored at -80°C were blinded and aliquoted at an independent site and shipped back to the testing site for parallel testing. Automated, magnetic-bead based RNA extraction was conducted according to each assay’s EUA-approved protocol. RT-qPCR with both assays was performed on an Applied BioSystems 7500 Fast Dx Real-Time PCR instrument. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Discordant samples were evaluated using the Roche SARS-CoV-2 assay on a cobas® 6800 system at an independent facility (Poplar Healthcare, TN, USA).
Results:Of the 240 samples, 14 samples were excluded from the cohort due to invalid/non-interpretable results generated by the Lyra® assay (12 samples) and inconclusive results generated by the TaqPath assay (2 samples). The final study cohort consisted of 226 samples (107 positives and 119 negatives). The PPA between the two assays was 93.5% and the NPA was 93.3%, with a total of 15 discordant results between the two assays. Of the 15 discordant samples, 3 samples did not produce conclusive results with the Roche SARS-CoV-2 assay. Of the remaining 12 discordant samples, arbitration was evenly split, with the resolver test agreeing with 50% of the discordant samples (6/12 samples each) for each assay.
Conclusions:Overall, a strong concordance was observed between the TaqPath™ COVID-19 Combo CE-IVD Kit and the Lyra® SARS-CoV-2 Assay. Arbitration testing using an independent assay generated an even split between the two assays.
Keyword(s): TaqPath, Lyra, SARS-CoV-2COI Stock Options: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Robertson (1), V. Mangale (1), A. Crawford (1), B. Mohajer (2), K. Clyde (2), O. Aceves (2), M. Gandhi (2), M. Schumaker (2), X. Wang (2)
Authors Affiliations(s): (1) Quantigen BioSciences, United States, (2) Thermo Fisher Scientific, United States
Background:
The TaqPath™ COVID-19 Combo CE-IVD Kit targets three SARS-CoV-2 genes (ORF1ab, N, S), whereas the Lyra® SARS-CoV-2 Assay targets a single SARS-CoV-2 gene (ORF1ab). Both assays use an automated RNA extraction protocol and bacteriophage MS2 as an exogenous process control. In this study, we compared clinical performance of the two above-mentioned RT-qPCR diagnostic tests with clinical nasopharyngeal swabs, using the Roche SARS-CoV-2 assay to resolve discordant results.
Methods:A retrospective study was conducted on residual nasopharyngeal specimens at Quantigen BioSciences in January 2021. A total of 240 samples were selected based upon results generated by an EUA-cleared test as part of routine clinical testing. Residual samples stored at -80°C were blinded and aliquoted at an independent site and shipped back to the testing site for parallel testing. Automated, magnetic-bead based RNA extraction was conducted according to each assay’s EUA-approved protocol. RT-qPCR with both assays was performed on an Applied BioSystems 7500 Fast Dx Real-Time PCR instrument. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Discordant samples were evaluated using the Roche SARS-CoV-2 assay on a cobas® 6800 system at an independent facility (Poplar Healthcare, TN, USA).
Results:Of the 240 samples, 14 samples were excluded from the cohort due to invalid/non-interpretable results generated by the Lyra® assay (12 samples) and inconclusive results generated by the TaqPath assay (2 samples). The final study cohort consisted of 226 samples (107 positives and 119 negatives). The PPA between the two assays was 93.5% and the NPA was 93.3%, with a total of 15 discordant results between the two assays. Of the 15 discordant samples, 3 samples did not produce conclusive results with the Roche SARS-CoV-2 assay. Of the remaining 12 discordant samples, arbitration was evenly split, with the resolver test agreeing with 50% of the discordant samples (6/12 samples each) for each assay.
Conclusions:Overall, a strong concordance was observed between the TaqPath™ COVID-19 Combo CE-IVD Kit and the Lyra® SARS-CoV-2 Assay. Arbitration testing using an independent assay generated an even split between the two assays.
Keyword(s): TaqPath, Lyra, SARS-CoV-2COI Stock Options: Yes