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

A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings

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.

The study is designed 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 on-site trained operators. Capillary (fingerstick) whole blood and EDTA whole blood samples will be collected by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on the TruPlex tests. Subsequently, the EDTA whole blood and SST whole blood samples will be further processed to obtain EDTA plasma and SST serum, respectively, for testing on the TruPlex. Blood samples will be collected and sent to the central laboratory 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.

A minimum of two TruPlex Test lots will be used for the study.

The following studies will also be performed:

Usability evaluation to assess user experience and success in label comprehension of the TruPlex test via a questionnaire.

Contrived result interpretation with a minimum of 15 intended users across a minimum of 3 clinical sites. Participants will be trained healthcare professionals that are paid employees of the study sites. Participants will have prior experience using rapid tests. Participants will evaluate a set of contrived tests to determine and document if intended users can successfully interpret various TruPlex Test results that include - strong positive, weak positive, negative, and a range of invalid results.

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 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.