Clinical Trial Comparing Two Types of Blood Samples (Plasma and SMARTplasma) for HIV and HCV Antibody Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 7
- 主要终点
- Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA)
研究概览
简要总结
The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).
详细描述
Following exposure to HIV and HCV, there is a "window period" where a person is infected with the virus but does not produce antibodies at a high enough level so they can be detected by antibody detection test methods. During this time, the person is capable of unknowingly transmitting the virus to others. SMARTstim (SMARTube)is a blood sample additive which pre-treats blood, stimulating antibody production in vitro so as to bring it to detectable levels using ELISA (or any other antibody test method). Accelerated antibody production allows antibody detection in specimens that would otherwise be below the detectable limit of antibody test kits. Plasma samples from blood pretreated with SMARTstim are referred to as "SMARTplasma".
A total of 1,600 blood samples will be collected and tested using an ELISA for HIV and HCV using FDA-approved test kits. The populations include:
- 1000 samples from low risk individuals (blood donors) from 3 geographical locations
- 500 samples from high risk individuals at risk for HIV from 2 geographical locations
- 100 known HIV seropositives
This is a non-linked study; that is, no subject identifiers will be associated with the collected blood. Subjects will not receive any correspondences and will not receive any test results.
If discordant results occur between the plasma and SMARTplasma samples, those samples will be retested. A Western Blot will be performed on ELISA repeat reactive discordant samples. HCV testing using an FDA-approved assay may also be performed using retained samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 18-64,
- •Are not pregnant
- •Not have a life-threatening disease
- •Not immunosuppressed (HIV therapy allowed)
- •Are able to give consent, and (6) who appear healthy.
排除标准
- •Do not meet the inclusion criteria
- •Are enrolled in an HIV vaccine study,
- •Who have previously been enrolled in this study
结局指标
主要结局
Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA)
时间窗: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
There is one timepoint (day 1)for which the primary outcome measure will be assessed and data will be presented. Samples will be collected, delinked and shipped to core lab within 1 day of collection where samples will be processed and subsequently analyzed for HIV and HCV antibodies. Samples will be frozen and retained for future testing. Results of all testing of correlating SMARTplasma and normal plasma samples will be reported as either positive or negative and these results will be compared for concordance.
次要结局
- Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma(Blood samples for HIV and HCV testing will be collected at time of consent (day 1).)
- Correlation of results from two different sample types (heparin vs EDTA)(Blood samples for HIV and HCV testing will be collected at time of consent (day 1).)
- Correlation of results from refrigerated versus frozen then thawed samples(Blood samples for HIV and HCV testing will be collected at time of consent (day 1).)