Condition: HIV 1 Infection · HIV 2 Infection · Syphilis Infection · Sponsor: bioLytical Laboratories
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.
This description comes directly from the study's public registry record.
Ana Subramanian · 16042046784 · asubramanian@biolytical.com
Patrick Diaz · 16042046784 · pdiaz@biolytical.com
Always discuss trial participation with your own doctor first.
| Epicentre Health Research (Johannesburg) | Johannesburg, Gauteng, South Africa | Recruiting |
| Epicentre Health Research | Durban, KwaZulu-Natal, South Africa | Recruiting |
| Epicentre Health Research (Cape Town) | Cape Town, Western Cape, South Africa | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07563309