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

NCT07569913 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • HIV1 Infection
  • HIV 2 Infection
  • Syphilis Infection
  • Hepatitis B Infection

Interventions

DEVICE

TruPlex HIV/HepB/Syphilis Rapid Test

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

Sponsors & Collaborators

  • Saint Vincent's Hospital Melbourne

    collaborator UNKNOWN

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-01-01
Completion
2027-06-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569913 on ClinicalTrials.gov