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NOT YET RECRUITING
NCT07569913
NA

A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test

Sponsor: bioLytical Laboratories

View on ClinicalTrials.gov

Summary

To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.

Official title: A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-09-01

Completion Date

2027-06-01

Last Updated

2026-05-06

Healthy Volunteers

Yes

Interventions

DEVICE

TruPlex HIV/HepB/Syphilis Rapid Test

A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.

Locations (1)

St Vincent's Hospital (Melbourne), Dept. of Gastroenterology

Melbourne, Victoria, Australia