Testing a rapid finger-prick device for HIV, hepatitis B and syphilis
Tests a quick finger-prick device for HIV, hepatitis B and syphilis in adults.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
Key facts
- Where
- Melbourne, AustraliaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are being tested for HIV, syphilis or hepatitis B. They give fingerstick and venous blood samples to test a new rapid test.
- Age
- 18 years or older
- Sex
- All sexes can join
- Earlier treatment
- People with known HIV who have been on antiretroviral treatment (ART) for 12 months or longer cannot join. People with unknown HIV status, or known HIV with less than 12 months of ART, can join.
Main reasons for not taking part
- Has a bleeding disorder
- Is currently being treated for syphilis
- Has received an experimental HIV vaccine
- Had a hepatitis B vaccine in the last 7 days
- Known HIV positive and on ART for 12 months or longer
Read by machine on 9 November 2026.
Where in Australia
- St Vincent's Hospital (Melbourne), Dept. of GastroenterologyMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- bioLytical Laboratories
- Trial code
- NCT07569913
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Subject has a bleeding disorder; 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; Subject is currently undergoing Syphilis treatment.