Product Manual
Sofia Lyme FIA Page 16 of 19
Table 11
Sofia Lyme FIA Precision – Within Run
IgM or IgG Sample
IgM Positive
IgM % Positivity
IgG Positive
IgG % Positivity
Run 1
Run 2
Total (n=96)
Run 1
Run 2
Total (n=96)
Negative
0/48
0/48
0.0%
0/48
0/48
0.0%
High Negative (C
5
)
3/48
5/48
8.3%
2/48
5/48
7.3%
Low Positive (C
95
)
48/48
48/48
100%
48/48
46/48
97.9%
Moderate Positive (2-3X)
48/48
48/48
100%
48/48
48/48
100%
Table 12
Sofia Lyme FIA Precision – Between Operator
IgM or IgG Sample
% IgM Positivity
IgM % Positivity
% IgG Positivity
IgG % Positivity
Operator1
Operator 2
Total (n=96)
Operator 1
Operator 2
Total (n=96)
Negative
0/48
0/48
0.0%
0/48
0/48
0.0%
High Negative (C
5
)
3/48
5/48
8.3%
3/48
4/48
7.3%
Low Positive (C
95
)
48/48
48/48
100%
47/48
47/48
97.9%
Moderate Positive (2-3X)
48/48
48/48
100%
48/48
48/48
100%
Reproducibility
The reproducibility of the Sofia Lyme FIA was evaluated at 3 different laboratories, 1 of which was Quidel. Two
operators at each site tested a series of coded, contrived samples ranging from negative to moderate positive
IgM and IgG concentrations. Testing occurred for a minimum of 5 separate days, spanning a period of
approximately 1 month. The inter-laboratory agreement for the IgM test on negative samples was 100%,
100% for high negative, 100% for low positive, and 100% for moderate positive samples. The inter-laboratory
agreement for the IgG test on negative samples was 100%, 100% for high negative, 86.7% for low positive, and
100% for moderate positive samples, see Table 13 for results.
Table 13
Sofia Lyme FIA Reproducibility Study Inter-laboratory Agreement
Site
IgM
Negative
(C
0
)
IgM High
Negative (C
5
)
IgM Low
Positive
(C
95
)
IgM
Moderate
Positive
(2-3X LOD)
IgG Negative
(C
0
)
IgG High
Negative (C
5
)
IgG Low
Positive
(C
95
)
IgG Moderate
Positive
(2-3X LOD)
1
30/30
30/30
30/30
30/30
30/30
30/30
27/30
30/30
2
30/30
30/30
30/30
30/30
30/30
30/30
26/30
30/30
3
30/30
30/30
30/30
30/30
30/30
30/30
25/30
30/30
Total
90/90
90/90
90/90
90/90
90/90
90/90
78/90
90/90
% Overall
Agreement
(95% CI)
100%
(95.1-100%)
100%
(95.1-100%)
100%
(95.1-100%)
100%
(95.1-100%)
100%
(95.1-100%)
100%
(95.1-100%)
86.7%
(78.0-
92.4%)
100%
(95.1-100%)
Matrix Equivalency
Matched serum and plasma samples were collected from negative donors from a non-endemic region of the
United States. Samples were contrived with IgM and IgG concentrations that covered the dynamic range of the
assay. The comparative matrix for negative and positive IgM and IgG samples demonstrate that the performance
with matched serum and plasma samples were acceptable when using four tube types: Serum Separator Tube