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临床试验/NCT00378118
NCT00378118已完成不适用

Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old

Thrasher Research Fund1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Sensitivity and specificity of the OraQuick rapid test

研究概览

简要总结

Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva as an alternative specimen for HIV testing has been explored. Today, very sensitive tests have been formulated and have been used for diagnosing HIV in adults and older children. OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as well test the saliva.

Most studies done on the use of saliva have been carried out in adults and have produced very good results. However very few such studies have been done in children, especially infants. In adults, use of saliva has also highlighted the advantages of ease of collection and increased acceptability of testing.

HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine test and oral fluid testing is more acceptable than blood testing.

详细描述

BACKGROUND Serological identification of antibodies to Human Immunodeficiency virus (HIV) in blood is the most widely used method to screen for HIV infection. Use of oral fluid as an alternative to blood sample has been studies the past 20 years and extremely sensitive tests that are able to detect the very low quantities of antibodies found in oral fluid have been formulated and are currently being used. OraQuick rapid test, a combination, collection and testing device that uses both blood and oral fluid was approved for used by the U.S.A, FDA in 2002 and has been tested in adults and older children.

The value of oral fluid in screening for HIV infection in adults is now well established and has been used extensively in field survey and epidemiologic studies. However, these methods have not been studied in children in whom differences in test performance might be expected. Studies in adults have also highlighted the advantages of oral fluid testing, such as ease of collection and high degree of acceptability of testing. This would make oral fluid testing a good alternative for HIV screening in infants, a challenging population in which venipuncture is often difficult or unacceptable.

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
1 Day 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged less than 18 months
  • Admission to the Department of Pediatrics for any condition
  • Consent from caregiver for HIV testing using both oral fluid and blood r

排除标准

  • Age of more than 18 months
  • Refusal of consent by caregiver
  • Outpatients

结局指标

主要结局

Sensitivity and specificity of the OraQuick rapid test

时间窗: one year

次要结局

  • Acceptance of HIV testing using oral fluid(one year)

研究者

申办方类型
Other

研究点 (1)

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