To evaluate 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 evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
A prospective study 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 healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on TruPlex Tests. Subsequently, EDTA whole blood and SST whole blood samples will be further processed to obtain plasma and serum, respectively, for testing on the TruPlex. Additional venous whole blood samples will be collected and sent to the National Serology Reference Laboratory (NSRL) 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
500
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.
St Vincent's Hospital (Melbourne), Dept. of Gastroenterology
Melbourne, Victoria, Australia
Performance Evaluation
The study will assess the sensitivity and specificity of the TruPlex Test for detecting: * HIV-1 and HIV-2 antibodies * Syphilis antibodies * Hepatitis B surface antigen (HBsAg) Capillary blood, EDTA whole blood, EDTA-plasma and SST-serum samples will be tested using the TruPlex Test. Performance will be compared against approved, current on-market assays for the detection of HIV 1/2 antibodies, Syphilis antibodies, and HBsAg.
Time frame: 6 months
Usability Evaluation
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Time frame: 6 months
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