OBJECTIVE - To evaluate the prevalence of IgG antibodies to bovine ser
um albumin (BSA) in a cohort of Brazilian children and young adults wi
th IDDM. RESEARCH DESIGN END METHODS - Sera from 81 subjects with <1 y
ear of IDDM (group 1), 111 subjects with >1 year of IDDM (group 2), an
d 207 normoglycemic subjects were tested using an immunofluorimetric a
ssay. A receiver-operating-characteristic curve was used to establish
the threshold of anti-BSA antibody titers defining the positivity of t
he assay. RESULTS - The distribution of the fluorimetric index (FI) of
anti-BSA antibodies did not have a gaussian profile. Rank sum of FI w
as significantly higher inpatients than in control subjects (P < 0.000
1). Average logFI values of both IDDM groups were significantly higher
than that of the control group (P < 0.005 for both groups). There was
a trend toward higher FI levels in group 1 than in group 2 (P = 0.06)
. A FI cutoff of 0.7 optimized the ratio of true-positive to false-pos
itive of the assay, with the best equilibrium between sensitivity and
specificity. The prevalence of anti-BSA antibodies was 52% in group 1,
47% in group 2, and 28% in the control group (P = 0.0001). An indepen
dent association between anti-BSA antibodies and IDDM, with an odds ra
tio of 3.03 (P < 0.0001), was observed in a logistic regression analys
is. However anti-BSA antibodies explained only 5% of the variability o
f IDDM versus NIDDM. CONCLUSIONS - Our results confirm that the preval
ence of anti-BSA antibodies is higher in IDDM subjects than in control
subjects, even after 1 year of diabetes. However, a large overlap of
antibody titers is observed in patients and control subjects, suggesti
ng that anti-BSA antibodies are neither sensitive nor specific markers
of IDDM.