RecruitingNot ApplicableNCT07563309

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

A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings

Sponsor

bioLytical Laboratories

Enrollment

1,000 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

hepatitis B infection HIV-1-infection Syphilis Infection HIV-2 Infection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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

Exclusion Criteria6

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.