COVID-19 RT-qPCR Test

Methodology: The COVID-19 RT-qPCR Test is a real-time reverse transcription polymerase chain reaction (RT-qPCR) test. This test uses two primers and probe sets to detect two regions in the SARS-CoV-2 Nucleocapsid (N) gene (N1 and N2) and one primer and probe set to detect human RNase P (RP) in a clinical sample. Specimen and Transport: Saliva is collected using the Oragene Dx OGD-510 device (DNA Genotek, FDA 510(k) # K141410). The collection kit is self-administrable, eliminating need for specialized training and minimizing risk due to close contact. After collection, the tube is shipped to Phosphorus using included packaging and envelope at ambient temperature. Turnaround Time: Within 72 hours from date of receipt at the laboratory Performance: Limit of Detection: 5 viral copies / μL Sensitivity: 98.3% Specificity: 98.8% Positive Predictive Value: 98.3% Negative Predictive Value: 98.8% Clinical & Stability Study: Clinical Performance: 91 Samples (35 positives and 57 negatives - confirmed by clinical assessment and qPCR testing by 3rd party EUA approved laboratories). Stability: 40 saliva samples analyzed at room temperature through live FedEx transport and through simulated temperatures between 22°C and 40°C for up to 56 hours.