Product Manual

Sofia Lyme FIA Page 12 of 19
Lyme disease. The summarized results in Tables 2 and 3 are presented to provide additional information about
the performance of the Sofia Lyme FIA compared to Western Blot with a blinded, characterized serum panel.
This does not imply an endorsement of the assay by the CDC.
Table 2
Sofia Lyme FIA tested with CDC Panel – IgM Results
Clinical Status
Sofia Lyme IgM
Western Blot Lyme IgM
n
Pos
Neg
% Agreement
with clinical Status
Pos
Neg
% Agreement
with clinical Status
Negative Controls
190
33
157
82.6%
0
190
100%
Early Lyme EM
Positive
60
49
11
81.7%
31
29
51.7%
Late Lyme
30
22
8
73.3%
17
13
56.7%
Table 3
Sofia Lyme FIA tested with CDC Panel – IgG Results
Clinical Status
Sofia Lyme IgG
Western Blot Lyme IgG
n
Pos
Neg
% Agreement with
clinical Status
Pos
Neg
% Agreement with
clinical Status
Negative Controls
190
25
165
86.8%
0
190
100%
Early Lyme EM
Positive
60
49
11
81.7%
19
41
31.7%
Late Lyme
30
30
0
100%
26
4
86.7%
Analytical Specificity
To determine the analytical specificity of the Sofia Lyme FIA, 200 seemingly healthy individuals with no known
history of physician-diagnosed Lyme disease were evaluated. Half of the samples (100) were collected from a
non-endemic Lyme region while the other half of the samples (100) were collected from an endemic Lyme region
of the United States. Samples were tested on Sofia Lyme FIA and the predicate Lyme IgM and IgG assays. The
Analytical Specificity results for Sofia Lyme FIA and the predicate devices are summarized in Table 4.
Table 4
Sofia Lyme FIA and Predicate Analytical Specificity
n
Sofia IgM
Predicate IgM*
Sofia IgG
Predicate IgG
Endemic
100
92.0%
95.0%
89.0%
97.0%
Non-Endemic
100
88.0%
86.0%
91.0%
100%
Total
200
90.0%
90.5%
90.0%
98.5%
*
Includes positive and equivocal results.
Sensitivity
To assess the sensitivity of the Sofia Lyme FIA, 95 well-characterized clinically or culture confirmed Lyme disease
serum samples were tested on Sofia Lyme and compared to the predicate IgM and IgG assays. The samples were
blinded and tested on both Sofia Lyme FIA and the predicate Lyme IgM and Lyme IgG tests. The Sofia results are
compared to those obtained with predicate Lyme IgM and IgG assays. Results for IgM and IgG are shown in
Tables 5 and 6.