Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Positive and Negative Percent Agreement
研究概览
简要总结
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.
详细描述
Background and Rationale:
At the end of 2018, the Public Health Agency of Canada (PHAC) noted 2,242 new HIV infections (incidence rate of 6 per 100,000 people) representing a slight increase from 2016 estimates. For the same period, PHAC estimated there were 62,050 Canadians living with HIV (prevalence rate 167 per 100,000) and about 18,700 Canadians were missed throughout the HIV care continuum, including 8,300 who are living with HIV but were undiagnosed. This represents about 13% of Canadians living with HIV but are unaware of their status and not in care.
As testing is the entry point to HIV care, it is likely that those who are undiagnosed are not engaging in HIV testing services. PHAC's "Pan-Canadian Framework for Action " sets out an overarching and comprehensive approach to address sexually transmitted and blood-borne infections including HIV, and is composed of 26 opportunities for action, including enhancing testing. Testing opportunities which include elimination of barriers to access testing and normalization of testing through primary healthcare providers (HCPs), strategies that use community-based services and HIV self-testing could help Canada reach the undiagnosed. However, testing by HCPs within clinical settings remains the foundation to Canadian HIV care programs.
Point-of-care (POC) tests for HIV may have substantial utility for increased identification of HIV-infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the HCP still has access to the patient. OraSure Technologies, Inc. has developed a POC test, the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test, which requires no additional instrumentation and can be used by HCPs in multiple near patient settings. The OraQuick ADVANCE® Test is a single-use, visually read, qualitative, in vitro lateral flow immunoassay to detect antibodies to HIV-1 and HIV-2 in oral fluid and fingerstick blood. The Test package includes a specific step-by-step instructions, the device, testing buffer solution and a device stand. It is available in the United States (FDA approved) but is not currently approved for use in Canada.
Currently only blood-based POC tests for HIV are licensed for use in Canada. Having a licensed, oral-fluid test in addition to blood-based tests available for use in Canada provides another option to increase the uptake of HIV testing, and further increase the potential of reaching undiagnosed individuals living with HIV in Canada. Studies have shown that interest and acceptability of testing with oral fluid is high.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Subject enrollment is by unblinded staff and testing is by blinded healthcare providers
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 18 years of age
- •Are able to provide informed consent
- •Are paid employees of the study site(s)
- •Are able to perform the study procedures outlined in the protocol
- •Healthcare provider
排除标准
- •Have used or watched someone use the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
- •Patient Inclusion Criteria:
- •Are at least 18 years of age
- •Are able to provide informed consent
- •Agree to provide accurate medical history
- •Are able to provide up to 20mL blood by venipuncture, an oral fluid and a fingerstick blood sample
- •Agree to undergo testing with the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
- •Patients with the known HIV positive status (diagnosis must be within five years of the study visit)
- •Patients with unknown HIV status (last HIV negative test must be greater than 6 months prior to study visit)
- •Patient Exclusion Criteria:
- •Are site employees
- •Are in the judgment of the investigator unable to complete the study or are unlikely to comply with the study protocol; or
- •Have been previously enrolled in this study.
结局指标
主要结局
Positive and Negative Percent Agreement
时间窗: 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.
次要结局
- Usability and Label comprehension(1 year, year 1)