HIV Antibody Testing Clinical Trial
Official title:
Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective