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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Performance Evaluation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •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
排除标准
- •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.
研究组 & 干预措施
TruPlex HIV/HepB/Syphilis Rapid Test Performance
Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test.
干预措施: TruPlex HIV/HepB/Syphilis Rapid Test (Device)
结局指标
主要结局
Performance Evaluation
时间窗: 6 months
The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported.
次要结局
- Usability Evaluation(6 months)
- Contrived result interpretation evaluation(6 months)