Comparison of Real‐Q 2019‐nCoV and DaAn Gene 2019‐nCoV polymerase chain reaction assays for the detection of SARS‐CoV‐2

BACKGROUND: Various nucleic acid amplification assays for the diagnosis of SARS‐CoV‐2 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real‐Q 2019‐nCoV assay targeting the E and RdRP genes to DaAn Gene 2019‐nCoV kit targeting the N gene and ORF1ab in the diagnosis of SARS‐CoV‐2. METHODS: We performed a diagnostic comparison study by testing nasopharyngeal samples for SARS‐CoV‐2 using the two reverse transcription polymerase chain reaction (RT‐PCR) assays. Assay agreement was assessed by overall percent agreement, negative percent agreement, positive percent agreement, and Cohen's kappa coefficient. RESULTS: A total of 48 nasopharyngeal samples were tested using the two assays. One sample was invalid, and three showed inconclusive results with Real‐Q; hence, 44 were included for the comparative analysis. Overall, percent agreement between the assays was 93.2% (95% CI 81.3%–98.6%), Positive percent agreement (PPA) was 86.4% (95% CI 65.1%–97.1%) and negative percent agreement (NPA) was 100% (95% CI 84.6%–100%). The kappa coefficient was 0.86 (95% CI 0.72–1.01). Three samples (6.8%) were positive with DaAn gene kit and negative with Real‐Q. The fluorescence intensity for Real‐Q reporter dyes was low. CONCLUSION: The two kits showed high levels of concordance in their detection of SARS‐CoV‐2 despite having different gene targets. The Biosewoom kit can be improved through addressing the fluorescence intensity of the target dyes, and feedback was given to the manufacturer.