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

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 experience in using Seegene molecular kit for COVID-19 (CO-rona VI-rus Disease) at the San Donato Hospital in Arezzo, a territorial support hospital structure for the molecular screening COVID-19. The investigation strategy is based on molecular analysis starting from RNA extract obtained from oropharyngeal / nasal / sputum swabs. The problem linked to this type of samples consists mainly in obtaining an intact analysis matrix not affected by degradation due to incorrect conservation or by the presence of RNase.