Clinical Information

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is a positive-sense, single-stranded RNA virus that causes coronavirus disease 2019 (COVID-19). Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract illness. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. As the disease progresses, the viral load tends to decrease in the upper respiratory tract, at which point, lower respiratory tract specimens (eg, sputum, tracheal aspirate, bronchoalveolar fluid, transbronchial biopsy, wedge biopsy of lung, autopsy lung specimen) would be more likely to have detectable SARS-CoV-2. Infection of other tissue has been reported.

The SARS-CoV-2 RNA detection in formalin-fixed and paraffin-embedded (FFPE) tissue by droplet digital polymerase chain reaction (ddPCR) assay will be used to detect the nucleocapsid N1 and N2 target sequences of SARS-CoV-2 virus in FFPE surgical and autopsy tissue. The identification of SARS-CoV-2 in surgical tissue may aid in the diagnosis of COVID-19 and may lead to a better understanding of unusual disease presentations. Detection of SARS-CoV-2 in deceased patients (autopsy tissue) may similarly confirm a suspected diagnosis among individuals with clinical or pathologic manifestations of COVID-19 (ie, pulmonary, cardiac) and may increase understanding of SARS-CoV-2 pathobiology.