Product Manual

Page 12 of 15
Sofia Strep A FIA
Limit of Detection
The limit of detection (LOD) for the Sofia Strep A FIA was determined using three (3) strains of Group A Streptococcus
pyogenes. The LOD ranged from 9x10
3
-2x10
4
colony forming units (cfu)/test (Table 6).
Table 6
Sofia Strep A FIA Limits of Detection for Three Streptococcus pyogenes Strains
Analytical Reactivity
Analytical reactivity for the Sofia Strep A FIA was determined using 15 strains of Streptococcus pyogenes. Each strain listed
below in Table 7 produced positive results in the assay.
Table 7
Analytical Reactivity
cfu/test = colony forming units/test
*The levels of bacteria were determined by limiting dilution,
bacterial culture, and colony counting to give cfu/test.
cfu/test = colony forming units/test
*The levels of bacteria were determined by limiting dilution,
bacterial culture, and colony counting to give cfu/test.
Streptococcus pyogenes Strain Test Quantity*
Strain #1 (ATCC 19615) 6.5x10
4
cfu/test
Strain #2 (ATCC 700942) 7.4x10
4
cfu/test
Strain #3 (ATCC 700952) 8.3x10
4
cfu/test
Strain #4 (Field Clinical Isolate) 3.1x10
4
cfu/test
Strain #5 (Field Clinical Isolate) 7.6x10
4
cfu/test
Strain #6 (Field Clinical Isolate) 7.1x10
5
cfu/test
Strain #7 (Field Clinical Isolate) 6.3x10
4
cfu/test
Strain #8 (Field Clinical Isolate) 6.3x10
4
cfu/test
Strain #9 (Field Clinical Isolate) 5.3x10
4
cfu/test
Strain #10 (ATCC 700482) 6.5x10
4
cfu/test
Strain #11 (ATCC BAA 1315) 7.2x10
4
cfu/test
Strain #12 (ATCC 700459) 5.4x10
4
cfu/test
Strain #13 (ATCC 12203) 6.9x10
4
cfu/test
Strain #14 (ATCC 700944) 5.3x10
4
cfu/test
Strain #15 (Field Clinical Isolate) 7.0x10
4
cfu/test
Strain Minimum Detectable Level*
Bruno [CIP 104226] 1.86x10
4
cfu/test
CDC-SS-1402 9.24x10
3
cfu/test
CDC-SS-1460 2.34x10
4
cfu/test