The sample used for the GENECUBE® examination analysis of SARS-CoV-2 was also used for the RT-PCR assays. All assays were performed with the previously described magLEAD conditions [10 (link)] (Fig 1 ). In addition to the standard protocol with magLEAD purification, a rapid protocol created by Hiromichi Suzuki, TOYOBO Co., Ltd. and Precision System Science Co., Ltd. were evaluated for saliva samples and samples for limit of detection (LOD) analysis. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 10 minutes. The comparison of the standard protocol and the rapid protocol for each magLEAD purification processes is summarized in Table 1 . The rapid protocol is commercially available in Japan as MagDEA Dx SV 200 for GENECUBE®.
If discordance was recognized between GENECUBE® and the reference RT-PCR, an additional evaluation was performed with Xpert® Xpress SARS-CoV-2 and GeneXpert® (Cepheid Inc., Sunnyvale, CA, USA) [15 (link)] analyses for anterior nasal samples according to the manufacturer’s instructions documented in the package insert, and with an RT-PCR with LightMix® Modular SARS-CoV (COVID19) E-gene (Roche Diagnostics KK) [16 (link)] for saliva samples along with re-evaluation with the NIID RT-PCR method.
If discordance was recognized between GENECUBE® and the reference RT-PCR, an additional evaluation was performed with Xpert® Xpress SARS-CoV-2 and GeneXpert® (Cepheid Inc., Sunnyvale, CA, USA) [15 (link)] analyses for anterior nasal samples according to the manufacturer’s instructions documented in the package insert, and with an RT-PCR with LightMix® Modular SARS-CoV (COVID19) E-gene (Roche Diagnostics KK) [16 (link)] for saliva samples along with re-evaluation with the NIID RT-PCR method.
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