A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care

Consists of the Pine Trees Health Reader and the Pine Trees Health COVID-19 Test Kit, which contains the Pine Trees Health Cartridge, Pine Trees Health Sample Vial containing Sample Lysis Buffer and the Pine Trees Health Nasal Swab (anterior nares) for collection. The Test System is a point-of-care test used for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in nasal swabs taken from individuals who are suspected by a healthcare professional of having COVID-19. The COVID-19 test is a rapid molecular, in vitro diagnostic test using isothermal nucleic acid amplification technology and detection of the resulting amplicon using CRISPR-mediated collateral reporter unlocking.