Product Manual

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Sofia Strep A FIA
Analytical Specificity
Cross Reactivity
The cross reactivity of the Sofia Strep A FIA was evaluated with a total of 61 non-Group A Streptococcus bacterial and fungal
microorganisms, and 26 viral isolates. None of the organisms or viruses listed below in Table 8 showed any sign of cross
reactivity in the assay. When the same organisms in Table 8 were pre-mixed with Group A Strep and tested in the Sofia StrepA
FIA, all results were positive also indicating that the potential cross-reactants did not interfere with the detection of Strep A.
Table 8
Analytical Specificity and Cross Reactivity
Organism/Virus Test Quantity* Organism/Virus Test Quantity*
Arcanobacterium haemolyticum 3x10
5
cfu/test Streptococcus sp. Group C strain #4 3x10
6
cfu/test
Bacteroides fragilis 3x10
7
cfu/test Streptococcus sp. Group C strain #5 3x10
5
cfu/test
Bordetella pertussis 3x10
7
cfu/test Streptococcus sp. Group D strain #1 3x10
6
cfu/test
Candida albicans 3x10
4
cfu/test Streptococcus sp. Group D strain #2 3x10
6
cfu/test
Corynebacterium diphtheria 3x10
5
cfu/test Streptococcus sp. Group D strain #3 3x10
6
cfu/test
Corynebacterium pseudodiphtheriticum 3x10
6
cfu/test Streptococcus sp. Group D strain #4 3x10
6
cfu/test
Enterococcus faecalis 3x10
6
cfu/test Streptococcus sp. Group D strain #5 3x10
6
cfu/test
Enterococcus faecium 3x10
6
cfu/test Streptococcus sp. Group F strain #1 3x10
5
cfu/test
Escherichia coli 1.5x10
7
cfu/test Streptococcus sp. Group F strain #2 3x10
6
cfu/test
Fusobacterium necrophorum 3x10
6
cfu/test Streptococcus sp. Group F strain #3 3x10
6
cfu/test
Haemophilus influenzae 3x10
7
cfu/test Streptococcus sp. Group F strain #4 3x10
5
cfu/test
Haemophilus parahaemolyticus 3x10
6
cfu/test Streptococcus sp. Group F strain #5 3x10
5
cfu/test
Klebsiella pneumoniae 3x10
7
cfu/test Streptococcus sp. Group G strain #1 3x10
7
cfu/test
Moraxella catarrhalis 3x10
6
cfu/test Streptococcus sp. Group G strain #2 3x10
6
cfu/test
Neisseria lactamica 3x10
6
cfu/test Streptococcus sp. Group G strain #3 3x10
6
cfu/test
Neisseria gonorrhoeae 3x10
6
cfu/test Streptococcus sp. Group G strain #4 3x10
6
cfu/test
Neisseria meningitidis 3x10
6
cfu/test Yersinia enterocolitica 3x10
6
cfu/test
Neisseria sicca 3x10
7
cfu/test Adenovirus Type 1 3x10
11
TCID50/test
Neisseria subflava 3x10
7
cfu/test Adenovirus Type 3 3x10
5
TCID50/test
Proteus vulgaris 3x10
7
cfu/test Adenovirus Type 4 1.5x10
2
TCID50/test
Pseudomonas aeruginosa 3x10
6
cfu/test Adenovirus Type 5 3x10
5
TCID50/test
Serratia marcescens 3x10
7
cfu/test Adenovirus Type 11 3x10
4
TCID50/test
Staphylococcus aureus 3x10
6
cfu/test Coronavirus 229E 3x10
4
TCID50/test
Staphylococcus epidermidis 3x10
6
cfu/test Coronavirus OC43 3x10
4
TCID50/test
Staphylococcus haemolyticus 3x10
5
cfu/test Coxsackievirus B5 (Faulkner) 3x10
6
TCID50/test
Staphylococcus intermedius 3x10
5
cfu/test Cytomegalovirus 3x10
3
TCID50/test
Staphylococcus saprophyticus 3x10
6
cfu/test Echovirus Type 3 1.5x10
4
TCID50/test
Streptococcus anginosus 3x10
6
cfu/test Epstein Barr virus 3x10
7
TCID50/test
Streptococcus gordonii 3x10
4
cfu/test Herpes Simplex virus 1 3x10
4
TCID50/test
Streptococcus mitis 3x10
4
cfu/test Herpes Simplex virus 2 3x10
4
TCID50/test
Streptococcus mutans 3x10
6
cfu/test Influenza A H1N1 3x10
4
TCID50/test
Streptococcus oralis 3x10
6
cfu/test Influenza A H3N2 3x10
4
TCID50/test
Streptococcus parasanguis 3x10
6
cfu/test Influenza B Hong Kong 3x10
4
TCID50/test
Streptococcus pneumoniae 3x10
6
cfu/test Influenza B Panama 1.5x10
4
TCID50/test
Streptococcus salivarius 3x10
5
cfu/test Influenza C Taylor 1.5x10
4
TCID50/test
Streptococcus sanguinis 3x10
6
cfu/test Measles (Edmonston) 3x10
4
TCID50/test
Streptococcus sp. Group B strain #1 3x10
6
cfu/test Mumps (Enders) 3x10
3
TCID50/test
Streptococcus sp. Group B strain #2 3x10
6
cfu/test Parainfluenza virus 1 3x10
4
TCID50/test
Streptococcus sp. Group B strain #3 3x10
6
cfu/test Parainfluenza virus 2 1.2 TCID50/test
Streptococcus sp. Group B strain #4 3x10
6
cfu/test Parainfluenza virus 3 3x10
6
TCID50/test
Streptococcus sp. Group B strain #5 3x10
6
cfu/test Parainfluenza virus 4A 3x10
4
TCID50/test
Streptococcus sp. Group C strain #1 3x10
6
cfu/test Rhinovirus Type 15 3x10
4
TCID50/test
Streptococcus sp. Group C strain #2 3x10
6
cfu/test Rhinovirus Type 1B 3x10
3
TCID50/test
Streptococcus sp. Group C strain #3 3x10
6
cfu/test
cfu/test = colony forming units/test TCID 50 /test = 50% tissue culture infectious dose
*The levels of bacteria were determined by limiting dilution, bacterial culture, and colony counting to give cfu/test. Virus concentrations were
determined by standard virology methods, Reed-Muench.