Clinical Investigation for 2019-nCoV Antigen Saliva Rapid Test Kit and V-CHEK SARS-CoV-2 Antigen Detection Kit to Detect COVID-19

This study is designed to analyze the agreements between the Investigational Device and an FDA approved SARS-CoV-2 NAATs and ensure that the Investigation Device is comparable to the reference method comparator. Clinical site staff will evaluate patients who exhibit COVID-19 symptoms and ask them if they would like to participate in this clinical study. Patients must meet the inclusion and exclusion criteria and be confirmed eligible to participate in the study. A minimum of two clinical sites is required for this study. Each site will enroll as many participants as possible to meet the initial screening criteria so that there are at least 30 positive COVID-19 results obtained when using the Investigational Device. Participants will be screen and those found acceptable will be asked to sign a consent form. After signing the consent form, each participants will be subjected to the standard COVID-19 test which will be sent to the lab for test results. Afterwards, study staff will collect another three specimens from the same participant. Collection include one nasopharyngeal swab (NP), one nasal swab (NS), and one saliva sample. The sample collected for NAAT testing should be transported according to the instructions suitable to the test to the testing laboratory. The NP swab can be collected from either nostril. Patient cannot eat, drink, smoke or chew gum for 30 minutes before giving saliva specimen. All collected samples should be tested immediately on the Investigational Device test cassette per the Instructions of Use (IFU). If an invalid result is observed, study group must repeat the test with a new cassette and use the same extraction tube. Staff must drip three drops of the extraction specimen on the well of the new cassette. All test results included those who are invalid must be recorded on the Case Report Form (CRF).

For each new shipment of products, new lot of products or each new operator an external control swab should be tested prior to participant testing and all result should be recorded.