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Not yet recruiting NCT07569913

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

No phase Interventional HIV1 Infection HIV 2 Infection Syphilis Infection Hepatitis B Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TruPlex HIV/HepB/Syphilis Rapid Test.
Who it may be relevant to
Registry conditions: HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device TruPlex HIV/HepB/Syphilis Rapid Test
    A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.

Primary outcome measures

  • Performance Evaluation [Time frame: 6 months]
Secondary outcome measures (1)
  • Usability Evaluation [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Australia · 1 center
  • St Vincent's Hospital (Melbourne), Dept. of Gastroenterology — Melbourne

Identifiers

NCT: NCT07569913 · CLS-021B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗