Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: TruPlex HIV/HepB/Syphilis Rapid Test for HIV1 Infection

To measure 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 measure the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.

Official registry: https://clinicaltrials.gov/study/NCT07569913 · bioLytical Laboratories · enrollment listed as 500

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TruPlex HIV/HepB/Syphilis Rapid Test. The registry lists allocation as na. To measure 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.

They plan to enroll about 500 people at Melbourne. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: TruPlex HIV/HepB/Syphilis Rapid Test

Primary outcome (registry wording): Performance Evaluation

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 18 years of age or older
  • 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
  • Note: Subjects who are pregnant and re-infected are eligible to participate

Public study contact (from the registry)

Ana Subramanian

16042046784

asubramanian@biolytical.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07569913 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07569913?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07569913?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary