Table 2.
Estimated limit of detection for SARS-COV-2 in copies/mL for individual assays.
| LOD95 in copy/mL determined in this studya |
||||
|---|---|---|---|---|
| Company | E | N | ORF1ab/RdRp | S |
| Altona Diagnostics | 3.8 (NA) | – | – | 3.8 (NA) |
| BGI | – | – | 4.3 (NA) | – |
| CerTest Biotec | – | 4.8 (NA) | 18 (13−56) | – |
| KH Medical | – | – | 4.8 (NA) | 4.3 (NA) |
| PrimerDesign | – | – | 23 (16−123) | – |
| R-Biopharm AG | 4.3 (NA) | – | – | – |
| SeeGene | 4.8 (NA) | NAb | 18 (13−56) | – |
| In-house PCR | 0.91 (0.61−2.4) | – | 3.1 (2.1−7.3) | – |
Abbreviations: E, envelope protein of SARS-CoV-2; LOD95, 95 % limit of detection; N, nucleocapsid protein of SARS-CoV-2; NA, not available; ORF, open reading frame; RdRp, RNA-dependent RNA polymerase of SARS-CoV-2; RT-PCR, reverse-transcription polymerase chain reaction; S, spike protein of SARS-CoV-2; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
a
The copy number was determined by digital PCR for the positive sense RdRp gene. Due to the limited range of the 2-fold dilution series, a confidence interval could not be determined for all assays.
b
The filter settings for the Seegene N-gene PCR were not correct and these results are therefore excluded.