Clinical Studies
Under its clinical study 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.
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The company is now entering into formal clinical trials for regulatory submissions. Some of these trials are underway and described below.
TEDI STUDY:
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.
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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.