NCT07563309

Brief Summary

The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings To evaluate the usability of the TruPlex test through: Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings. To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids). To monitor test system reliability, including invalid rates.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 18, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 21, 2026

Last Update Submit

April 29, 2026

Conditions

HIV 1 InfectionHIV 2 InfectionSyphilis InfectionHepatitis B Infection

Keywords

TruPlex HIV/HepB/Syphilis Rapid Test

Outcome Measures

Primary Outcomes (1)

  • Performance Evaluation

    The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported.

    6 months

Secondary Outcomes (2)

  • Usability Evaluation

    6 months

  • Contrived result interpretation 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 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 (3)

Epicentre Health Research (Johannesburg)

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

Epicentre Health Research

Durban, KwaZulu-Natal, 3650, South Africa

RECRUITING

Epicentre Health Research (Cape Town)

Cape Town, Western Cape, 7925, South Africa

RECRUITING

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 4, 2026

Study Start

December 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

ZA(3)