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.
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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…
Contacts

Ana Subramanian

16042046784

asubramanian@biolytical.com

CONTACT

Patrick Diaz

16042046784

pdiaz@biolytical.com

CONTACT