TABLE 2

Determination of the limit of detection of the QIAstat-Dx assay and comparison with the WHO-recommended PCR assaya

TABLE 2
  • a The limit of detection (LoD) is defined, according to the European Network of GMO Laboratories recommandations, as the lowest content of genetic material able to be detected in all 10 replicates. QIAstat-Dx and the WHO-recommended Charité RT-PCR assay for the E gene and RdRp gene were compared. QIAstat-Dx was tested using twofold dilutions of a second positive nasopharyngeal clinical sample (strain 2) around the previously estimated LoD until obtaining 10 replicates or a failed result. The in-house assay was tested for obtained LoD values using the same viral dilution conserved at +4°C, in the same 24 h.

  • b The estimated viral load (in copies per milliliter [cp/ml]) and replicate number are shown.