A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
Recruiting
N/A
Interventional Study
HIV 1 Infection
HIV 2 Infection
Syphilis Infection
Hepatitis B Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 1,000 (estimated)
- Sponsor
- bioLytical Laboratories · Industry
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About This Trial
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 sett…
Trial Locations
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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 able to speak/read/write English or a translator is available
* Subject is ge…
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