Under its clinical trial approvals, ZiP Diagnostics has completed analytical testing with patient samples to establish that high sensitivity and specificity are achieved for several of its viral and bacterial products including SARS-CoV-2.
The company is now entering into formal clinical trials for regulatory submissions. Some of these trials are underway and described below.
Obtain fresh samples from volunteers to help ZiP evaluate and optimise new point-of-care diagnostic tests for infectious diseases
The test evaluation, development and implementation (TEDI) study obtains fresh specimens from volunteers. Recruitment and sampling is being coordinated by the Victorian Infectious Diseases Service, Royal Melbourne Hospital (RMH). Samples are being used as negative clinical matrixes to optimise novel diagnostic tests and for early-stage analytical validation of these tests.
Lead investigator: Assoc/Prof Joe Sasadeusz (RMH)
Co-investigator: Assoc/Prof Jack Richards
Study Coodinators: Dr. Jennifer Audsley (RMH), Dr. Rebecca Dabbs (ZiP)
RMH Research Nurse: Ms. Jo Patterson (RMH)
Institutions: Royal Melbourne Hospital, Victorian Infectious Diseases Service Outpatient Department, Parkville, Australia. ZiP Diagnostics Pty Ltd, Collingwood, Australia.
Field validation of the ZiP-CoVx-P2 diagnostic system for detection of SARS-CoV-2 virus
Field validation of the ZiP-CoVx-P2 diagnostic system will commence in Ghana, April 2022. This study is supported by a grant from the British Society of Antimicrobial Chemotherapy. Field trips are being undertaken to collect swab samples (throat, nasal, and saliva) in communities where high- and low-income earners reside, as well as in public areas such as markets, schools, and malls. Individuals recruited will be those who display (symptomatic testing) or do not display (asymptomatic screening) COVID-19 symptoms. Testing is currently underway in Ghana.
Lead investigator: Dr. Charles Narh
Co-investigators: Assoc/Prof Jack Richards, Dr. Lydia Mosi and Mr. William Hopper
Institutions: ZiP Diagnostics Pty Ltd, Collingwood, Australia. Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana. Biochemistry, Cell and Molecular Biology (BCMB), University of Ghana, Legon, Ghana. West African Centre for Cell Biology of Infectious Pathogens (WACBIP), University of Ghana, Ghana.