Point-of-care (POC) tests for HIV are easy to use, rapid and provide accurate results while the patient is still in-front of a healthcare provider (HCP). Currently only blood-based POC tests for HIV are licensed for use in Canada. The OraQuick ADVANCEĀ® HIV-1/2 Rapid Antibody Test is a POC test developed by OraSure Technologies, Inc. to detect HIV antibodies in oral fluid and fingerstick blood samples. As this device is very similar to the OraQuick HIV Self-Test, Health Canada requires evidence that HCPs can successfully perform the POC version of the OraQuick test in addition to performance of the self test version by intended users. This study involves a minimum of 9 HCPs and 600 Patients at clinic sites in Toronto and Ottawa (Ontario), Montreal (Quebec) and Edmonton (Alberta). It will assess the OraQuick ADVANCEĀ® Test's simplicity and accuracy in the hands of HCPs who have never used this Test. To assess performance, using only the test kit instructions for use, HCPs will collect and test oral fluid and fingerstick blood samples from patients with the OraQuick ADVANCEĀ® Test and will then read and interpret those results. Results of the OraQuick ADVANCEĀ® Test will be compared with results of a venous blood sample collected from each patient and tested with a usual, licensed, laboratory test method. To assess usability, HCPs will interpret various mock device test results and respond to a questionnaire to determine if the test instructions for use are clear and simple, that they are aware of test requirements and limitations and provide opinions on the ease of use of the test. A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process.
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Positive and Negative Percent Agreement
Timeframe: 1 year, year 1