Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04810559|
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : June 29, 2022
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 ADVANCE® 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 ADVANCE® 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 ADVANCE® Test and will then read and interpret those results. Results of the OraQuick ADVANCE® 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Testing HIV Infections||Device: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cross-sectional, prospective, field trial (near patient study)|
|Masking:||None (Open Label)|
|Masking Description:||Subject enrollment is by unblinded staff and testing is by blinded healthcare providers|
|Official Title:||Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood|
|Actual Study Start Date :||July 29, 2021|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||September 2022|
|Experimental: Investigational Device||
Device: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in oral fluid and fingerstick blood conducted by untrained healthcare providers compared to laboratory 4th generation Ag/Ab EIA results performed on venous blood.
- Positive and Negative Percent Agreement [ Time Frame: 1 year, year 1 ]
At the end of the study, positive and negative percent agreement (with two-sided 95% confidence interval for both) between OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test and laboratory reference test for each matrix (fingerstick and oral fluid) will be calculated separately.
For mock device interpretation, agreement of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each healthcare provider test operator.
- Usability and Label comprehension [ Time Frame: 1 year, year 1 ]At the end of all testing, to assess usability, healthcare providers will interpret various mock device test results and respond to 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810559
|Contact: Sean B Rourke, PhD||(416) firstname.lastname@example.org|
|Contact: Darshanand Maraj, MBBS||(416) 864-6060 ext email@example.com|
|The LGBTQ+ Wellness Centre (Medi Drugs Millcreek)||Not yet recruiting|
|Edmonton, Alberta, Canada|
|Contact: Dylan Moulton, PharmD|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Darrell Tan, MD|
|Women's Health in Women's Hands Community Health Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Megan Saunders, MD|
|Clinique médicale l'Actuel||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Réjean Thomas, MD|
|Principal Investigator:||Sean B Rourke, PhD||MAP Centre for Urban Health Solutions, St. Micheal's Hospital|