Product Manual
Sofia Lyme FIA Page 13 of 19
Table 5
Lyme IgM Results for Sofia Compared to Predicate Assay
Sofia IgM
Predicate IgM
Category
n
Pos
Neg
% Sens
95% CI
Pos
Equiv
Neg
%Sens
1
95% CI
Acute, < 1 month,
with EM
64
39
25
60.9%
48.7-72.0%
28
8
28
56.3%
44.1-67.7%
Acute, 1-2 months,
with EM
4
3
1
75.0%
28.9-96.6%
2
0
2
50.0%
15.0-85.0%
Convalescent, 3-12
months, with EM
15
11
4
73.3%
47.6-89.5%
6
2
7
53.3%
30.1-75.2%
Late Lyme (>1 yr),
Neuro or Arthritic
12
8
4
66.7%
38.8-86.5%
7
3
2
83.3%
54.0-96.5%
All Categories
95
61
34
64.2%
54.2-73.1%
43
13
39
58.9%
48.9-68.3%
1
Of the 13 samples that were “equivocal” by the predicate, 12 of 13 were negative by FDA approved western blot.
Table 6
Lyme IgG Results for Sofia Compared to Predicate Assay
Sofia IgG
Predicate IgG
Category
n
Pos
Neg
% Sens
95%CI
Pos
Neg
% Sens
95%CI
Acute, < 1 month,
with EM
64
50
14
78.1%
66.5-86.6%
28
36
43.8%
32.3-55.9%
Acute, 1-2 months,
with EM
4
4
0
100%
54.3-100%
3
1
75.0%
28.9-96.6%
Convalescent, 3-12
months, with EM
15
10
5
66.7%
41.5-85.0%
6
9
40.0%
19.8-64.3%
Late Lyme (>1 yr),
Neuro or Arthritic
12
12
0
100%
78.4-100%
10
2
83.3%
54.0-96.5%
All Categories
95
76
19
80.0%
70.8-86.9%
47
48
49.5%
39.6-59.4%
Prospective Clinical Study
A prospective study was performed using 678 serum samples collected from patients that were submitted for
routine Lyme disease testing in the United States. These samples were prospectively collected from ten different
clinical sites located in endemic areas of 4 states, as well as clinical laboratory remnant specimens that were
collected from endemic areas of 6 states. Sofia Lyme FIA testing was performed at 3 laboratories, including 1
Quidel site. The predicate Lyme IgM and IgG assays and western blot Lyme IgM and IgG assays were performed
at 2 distinct sites that were different from the 3 Sofia testing sites. First tier results for Sofia and the predicate
assays are shown in Tables 7 and 8.
Retrospective Clinical Study
A retrospective study was performed using 52 serum samples obtained from a commercial vendor, which were
previously characterized as positive for anti- B. burgdorferi antibodies. This serum sample set was not included
in any other Sofia Lyme FIA testing. First tier results for Sofia and the predicate assays are shown in Tables 7 and
8.