Clinical Validation of ZiP-CoVx-P2 for COVID-19 point-of-care test in Ghana (VaZico Study Ghana)

This is a multi-site prospective cross-sectional study seeking recruitment of 1000 study participants (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater Accra and Central Regions of Ghana. Participants may be symptomatic or asymptomatic for respiratory symptoms. Study participants will be asked to provide two swabs where the same clean swab will be used to take an oropharyngeal (throat) sample and then followed by a bilateral mid-turbinate (nasal) sample. Participants will be encouraged to provide a combined throat and nasal swab sample but will be given the option to provide a single sample type if they feel uncomfortable having the same swab being used to swab the throat and nose. Optionally, participants can also provide saliva samples. The samples will be collected by trained field staff following standard operating procedures (SOPs) in the study protocol. All field staff will report to the study coordinators, who will be responsible for all activities at the field sites. Of the two swabs collected per participant, one swab will be processed and tested on the ZiP-CoVx-P2 platform for the presence of SARS-CoV-2 virus RNA. The other will be used for RT-PCR (gold standard for SARS-CoV-2 detection). The ZiP-CoVx-P2 is an integrated cartridge-instrument platform that uses novel, low-cost nucleic acid amplification test (NAATs) technology. This test platform uses respiratory swabs and provides a test result within 30 minutes of sample collection. Testing on the ZiP-CoVx-P2 platform and with RT-PCR will be performed by trained research staff following the manufacturers’ instructions. All the Vazico team members including field and lab staff will be trained to perform the following: a. Reading the study protocol and participating in an education session on the associated study procedures. b. Reading the ZiP-CoVx-P2 Instructions for Use, and the ZiP-P2 instrument User Manual and practising the ZiP-CoVx-P2 point-of-care molecular test platform under supervision. c. Swab collection standard operating procedure (SOP) developed as outlined in the study protocol. All the field staff are trained to strictly adhere to the sample collection procedure as outlined. The study coordinators monitored field staff daily to ensure the field staff followed the proper procedures according to the study protocol.