Comparison of nine different commercially available molecular assays for detection of SARS-CoV-2 RNA

Abstract

To face the COVID-19 pandemic, the need for fast and reliable diagnostic assays for the detection of SARS-CoV-2 is immense. We describe our laboratory experiences evaluating nine commercially available real-time RT-PCR assays. We found that assays differed considerably in performance and validation before routine use is mandatory.

Keywords: COVID-19; Coronavirus; Diagnostics; Infectious disease; Laboratory diagnostics; Molecular testing; Real-time PCR; SARS-CoV-2.

Fig. 1

Analyses of SARS-CoV-positive samples (n = 8206) over 14 weeks from February to May at the LGL: the histogram gives, Ct values after amplification within the E-Gen (AT-E) (blue, detection of B lineage betacoronavirus, n = 8021, 9.47% of positive samples only E gene positive) and the S-Gen(AT-S) (red, detection of SARS-CoV-2, n = 7425, 2.25% of positive samples only S gene positive), RealStar SARS-CoV-2 RT-PCR Kit RUO, Altona Diagnostics against the number of samples. COVID, coronavirus disease; LGL, Bavarian Health and Food Safety Authority

Fig. 2

Multiple correlation of different assays (abbreviation see Table 1). Diagonal shows the distribution of Ct values of positive tested samples in histogram. Numbers represent the Pearson standard correlation coefficient (R)