The test evaluation, development and implementation (TEDI) study recruits asymptomatic individuals to provide negative clinical samples with the purpose of developing and validating new point-of-care of diagnostic tests for a range of infectious diseases.

Not Applicable

Recruiting

• Conditions: Dengue; Hepatitis B; tetanus; Malaria; Hepatitis C; monkeypox; Infection - Other infectious diseases; COVID-19; Influenza; RSV

• Registration Number: ACTRN12623000837628
• Lead Sponsor: ZiP Diagnostics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-04
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Written informed consent is provided.
Age: 18 years years and older

Exclusion Criteria

None

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop an optimised point-of-care test that meets pre-specified test specifications. [Cumulative samples will be assessed at a single timepoint that will occur when all negative samples have been collected. Samples will be stored at or below -20oC until tested.];Determine the sensitivity and specificity of a new diagnostic test ZiP-CoVx-P2 test” for COVID-19 compared to laboratory-based polymerase chain reaction (PCR) analysis as the gold-standard comparator[Cumulative samples will be assessed at a single timepoint that will occur when all negative samples have been collected. Samples will be stored at or below -20oC until tested.<br><br>]

Secondary Outcome Measures

Name	Time	Method
one[None]