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HPTN
Central Laboratory Policy
Verification of HIV Infection Status of Study Subjects
In order to verify the
HIV infection status of clinical trial participants, the HPTN Central Lab
will perform the following testing as a quality assurance measure:
1)
Baseline plama/serum samples from 50 or ten percent of randomly selected
enrolled adult subjects (whichever is greater) at each site will be
retested for HIV antibody by the Central Laboratory using FDA licensed
tests. Samples from all subjects will be retested if there are less than
50 total trial subjects. In the event of a false positive or false
negative result which changes the infection status of the subject, an
additional 100 or 20% of samples (whichever is greater) from enrolled
subjects will be retested.
2)
Baseline and seroconversion plasma/serum samples from all
seroconverting adult subjects and an equal number of randomly selected
samples from uninfected subjects will be retested by the Central Lab using
FDA licensed tests (ie., HIV antibody, HIV DNA PCR or HIV RNA if
necessary). In the event of false positive or false negative result, which
changes the endpoint infection status of the subject, a sample from the
last visit from all subjects will be retested.
3)
Plasma/serum samples from all HIV infected infants in perinatal trials and
an equal number of randomly selected uninfected infants will be retested
by the Central Lab using FDA licensed tests (ie., HIV antibody, HIV DNA
PCR or HIV RNA). In the event of false positive or false negative result
which changes the endpoint infection status of the subject, a sample from
the last visit from all subjects will be retested.
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