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

April 29, 2026 updated by: bioLytical Laboratories

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective study to evaluate TruPlex Test when used by trained users.

Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex Tests by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on TruPlex Tests. Subsequently, EDTA whole blood and SST whole blood samples will be further processed to obtain plasma and serum, respectively, for testing on the TruPlex. Additional venous whole blood samples will be collected and sent to the National Serology Reference Laboratory (NSRL) for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital (Melbourne), Dept. of Gastroenterology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TruPlex HIV/HepB/Syphilis Rapid Test Performance
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
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Evaluation
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Evaluation
Time Frame: 6 months
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

bioLytical Laboratories

Collaborators

Saint Vincent's Hospital Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS-021B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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