Abstract:

: The clinical presentation of COVID-19 is non-specific, and to improve and limit the spread of the SARS-CoV-2 virus, an accurate diagnosis with a robust method is needed. A total of 500 nasopharyngeal swab specimens were tested for SARS-CoV-2. Of these, 184 samples were found to be positive with Allplex™ 2019-nCoV Assay, which is fully automated. All the positive samples were retested with TaqPath™ COVID-19 CE-IVD RT-PCR Kit (after this, referred to as TaqPath™ COVID-19), semi-automated. The comparison of RT-qPCR for SARS-CoV-2 genes target points shows only one target point in common, the N gene. Therefore, the N gene was used to compare both assays. We noticed different Ct values between the tests. Therefore, samples were divided into four groups depending to the Ct value results: (1) Ct < 25, (2) Ct 25–30, (3) Ct 30–35, (4) Ct > 35. TaqPath™ COVID-19 Kit reconfirmed the results obtained from Allplex™ 2019-nCoV Assay. In conclusion, both the Allplex™ 2019-nCoV assay and TaqPath™ COVID-19 tests accurately confirm the diagnosis of SARS-CoV-2 infection. Even if TaqPath™ COVID-19 has a semi-automated workflow, it does not introduce bias in the diagnostic screening of SARS-CoV-2, and it supports the indirect identification of variants of concern to undergo sequencing.

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