Bosch Vivalytic SARS-CoV-2 Guia De Inicio Rapido página 6

Vivalytic SARS-CoV-2 – Instructions for use
• There is a risk of false negative values resulting from improperly collected,
transported or handled samples.
Analytical Sensitivity (Limit of Detection, 95 % Detection rate)
The concentration at a detection rate of 95 % (LoD) was determined (table 1).
Inclusivity and Exclusivity
Specificity was ensured by the selection of primers and probes and their in
silico analysis for possible cross-reactions based on publicly available nucleic
acid sequences derived from the NCBI database.
To evaluate inclusivity, positive SARS-CoV-2 material (table 2) were purified
and spiked into a PCR reaction and processed by a workflow using liquid
components.
To exclude cross-reactivity (exclusivity), various strains of microorganisms
representing common respiratory pathogens or closely related species
were tested (table 3) by a workflow using liquid components. There was no
evidence of microbial interference.
Interferences
Interferences were evaluated for endogenous and exogenous substances
(table 4) that are potentially present in the patient sample. No interferences
were detected.
Sensitivity and Specificity
The results derived from patient samples (positive and negative samples in
Copan eNAT™ medium) collected in a clinical setting were compared with
those of a reference method (table 5). In total, 69 samples were analysed.
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