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WALK AWAY Mode – Walk away and multitask READ NOW Mode – Batch multiple samples per hour
Sofia 2 Development Modes
L
y
m
e
L
y
m
e
3-15mins
L
y
m
e
L
y
m
e
L
y
m
e
L
y
m
e
L
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L
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15
Finger-stick Whole Blood
S
ofia 2 Lyme FIA – Procedure
Allow
Tube to
E
mpty
Twist
off
Squeeze
Shake Up
and Down
5x
Invert
L
y
m
e
Squeeze
2x
P
lace sample here
Lyme
Fill to
Black Line
Sofia 2 Lyme FIA – 15 Test Kit: Catalog #20319
Sofia 2 Lyme FIA
Differentiated IgM and IgG results with a single
test
Objective and automated results with no
equivocal zone
CLIA-waived for finger-stick whole blood
samples
Room temperature storage
18-month shelf life from date of manufacture
SL2603 l SS2031901EN00 (08/18)
Agreement with Predicate Assay and
Western Blot*
Result Type
Tier One PPA
Tier One NPA
Tier Two PPA
IgM
82.4%
79.8%
94.1%
IgG
88.9%
85.9%
95.7%
Category
Endemic
Non-Endemic
IgM
86%
93%
IgG
95%
98%
Specificity*
*Refer to the Package Insert for additional performance claims.
Comparator Method
Predicate Assay
Predicate Assay
Western Blot
CLIA
WAIVED
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