Available online 24 April 2023, 115970
Author links open overlay panel, , , , , , , , , , Highlights•Three Seegene Allplex™ Assays and a Hologic Aptima™ Assay were evaluated.
•Excellent performances were shown for SARS-CoV-2, Influenza type A/B virus and RSV.
•The extraction-free and LAMP assays allow increased testing capacity/productivity.
•TTime is a new result parameter, which may be used as a surrogate for Ct-value.
AbstractWe evaluated the diagnostic performance of four commercially NAAT for detecting SARS-CoV-2 RNA, Influenza type A/B virus and RSV. Included tests were the Allplex™ SARS-CoV-2 fast PCR Assay (RNA extraction-free), Allplex™ RV Master Assay, Allplex™ SARS-CoV-2 fast MDx Assay (LAMP) and Aptima™ SARS-CoV-2/Flu Assay (RT-TMA). The assays’ performance characteristics were determined using nasopharyngeal swabs from 270 patients with suspected SARS-CoV-2 infection. A total of 215 SARS-CoV-2 positive, 55 negative nasopharyngeal swabs and nineteen bacteria strains were included. The sensitivities and specificities for detecting SARS-CoV-2, Influenza type A virus and RSV ranged between 81.8% and 100% with extremely good agreements (κ ≥ 86.8 %). The Aptima™ SARS-CoV-2/Flu Assay introduced a new result parameter, i.e. TTime. Here, we showed that TTime may be used as a surrogate for Ct-value. We concluded that all assays assessed in this study can be used for routine detection of SARS-CoV-2, Influenza type A virus and RSV.
Key wordsSARS-CoV-2
COVID-19
RT-PCR
RT-TMA
comparison
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