Irene Alessandra Galanti Author

Short Communication Open Access

Potential False Negatives in the Molecular Diagnostics of COVID-19 Infection: Experience of an Italian Laboratory during the COVID-19 Epidemic

Author(s):

Alessandro Pancrazzi*, Roberta Perticucci, Stefania Vecchietti, Gianluca Magrini, Guendalina Vaggelli, Pasqualino Magliocca, Angelo Galano, Manuela Mafucci, Irene Alessandra Galanti and Agostino Ognibene

The current situation in the molecular diagnostics field applied to the SARS-CoV-2 (Severe Acute Respiratory Syndrome Corona virus 2) virus detection has forced various laboratories to quickly offer a solution for the identification of the infected people in this pandemic scenario recently declared by the World Health Organization.

In the epidemiological emergency, the rapid commercialization of CE-IVD kits pushed numerous hospitals to adopt these methods without complete internal validations that would allow evaluating the actual analytical methods limits. Moreover, the same WHO, given the global escalation of the epidemic, has listed the methods used so far for the viral RNA detection also in lack of validation data reports.

This communication reports the starting ... view more»

Abstract HTML PDF