NCT07569913

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2026

Last Update Submit

April 29, 2026

Conditions

HIV1 InfectionHIV 2 InfectionSyphilis InfectionHepatitis B Infection

Keywords

TruPlex HIV/HepB/Syphilis Rapid Test

Outcome Measures

Primary Outcomes (1)

  • Performance Evaluation

    The study will assess the sensitivity and specificity of the TruPlex Test for detecting: * HIV-1 and HIV-2 antibodies * Syphilis antibodies * Hepatitis B surface antigen (HBsAg) Capillary blood, EDTA whole blood, EDTA-plasma and SST-serum samples will be tested using the TruPlex Test. Performance will be compared against approved, current on-market assays for the detection of HIV 1/2 antibodies, Syphilis antibodies, and HBsAg.

    6 months

Secondary Outcomes (1)

  • Usability Evaluation

    6 months

Study Arms (1)

TruPlex HIV/HepB/Syphilis Rapid Test Performance

EXPERIMENTAL

Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test.

Device: TruPlex HIV/HepB/Syphilis Rapid Test

Interventions

TruPlex HIV/HepB/Syphilis Rapid TestDEVICE

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

TruPlex HIV/HepB/Syphilis Rapid Test Performance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Subject is able to provide and willing to sign and date the Informed Consent Form
  • Subject is able to complete the required testing on the allocated testing day.
  • Subject is able to speak/read/write English or a translator is available
  • Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons:
  • At risk for any one of the target diseases
  • Having signs or symptoms indicative of the target diseases
  • Routine testing
  • Note: Subjects who are pregnant and re-infected are eligible to participate
  • Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).
  • Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.
  • Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results

You may not qualify if:

  • Subject has a bleeding disorder
  • Subject is currently undergoing Syphilis treatment
  • Subject has received any experimental HIV vaccine
  • Subject received HBV vaccine within the last 7 days
  • Known HIV positive subjects and currently on ART for 12 months or longer
  • Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Melbourne, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Ana Subramanian

CONTACT

16042046784asubramanian@biolytical.com

Patrick Diaz

CONTACT

16042046784pdiaz@biolytical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

AU(1)