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KCE reports vol. 6A Prenatale zorg 129
Study Ref Population Intervention Outcomes Results Comments Study type EL
Diagnosis
Working
Group,
1992
Postma et
al.,
1999
Van
Doornum,
1998
4
[615]
4
[414]
Serum specimens
from 31,232
pregnant women
in Amsterdam
between 1988 and
1995
Performance of ELISA
as initial test for HIV as
specified for use in cost
effectiveness model
Two ELISA approach
(with membrane spot
assay to discriminate
between infection with
HIV-1 or HIV2 ) vs.
Western blot analysis
further testing with
different
assays (two). If both
confirmatory tests are
nonreactive, issue negative
report. If confirmatory
tests are reactive, one
more test with a new
specimen
should be obtained to
ensure no procedural
errors
have occurred
Evaluation of confirmatory
strategy of two-ELISA
approach and resolution of
indeterminate results with
NASBA and SIA
be used singly to generate a
negative report (unless HIV-2
assay is also needed)
HIV culture and tests for p24
antigen are not of much value in
diagnostic testing, as they may be
insensitive, non-specific and
expensive tests
Sensitivity 100%
Specificity 99.9%
42 sera that were available for
analysis which gave positive or
borderline results by ELISA and
indeterminate or negative results
by Western blot
All initially reactive samples
(tested by EIA) were retested by a
second ELISA (based on a
different principle) and the initial
screening assay
Confirmation of reactivity with a
second EIA, enhanced with a
membrane spot assay to
discriminate between HIV-1 and
HIV-2, was necessary and useful
the UK, high
specificity and
reasonable
sensitivity are
important
Unclear, but these
values seem to be
as reported from
the manufacturer
Diagnosis
Working
Group
EV 3