Research Article
Validation of a Sars-Cov-2 Nucleocapside N-Protein Detection Test in Saliva
Author(s):
M Coppola*, S Brenna, F Perna, V Maddaloni, P Imitazione, C De Falco, A Sanduzzi and L Atripaldi
An antigenic method for the quantification of SARS-CoV-2 nucleocapside protein (LUMIPULSE SARS-CoV-2 Ag- Fujirebio) both on naso-pharyngeal swab and on saliva has been evaluated on three groups of subjects: sub-intensive care unit hospitalized patients (n=24), patients discharged from this unit (n=22), controls (n=74). The molecular RT-PCR technique was considered the reference method. The cut-off value of 1.04 pg/mL distinguishes sick (hospitalized) from healthy (controls) with sensibility=0.937 and specificity=0.959; area under the ROC curve (0.978); efficiency=0.90. On saliva the qualitative antigenic result (positive if >cut-off) agrees with the qualitative molecular one (k=0.84). Stratifying by groups, in the hospitalized group (with clear prevalence of positives) there is a concordance of the positives of 97%; in the two groups of patients dischar.. Read More»
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