Item Brochure

A blue Test Line and a red Control Line is a positive result. A positive result means that the assay de-
tected Group A Streptococcus antigen in the specimen. Note that the blue line can be any shade of
blue and can be lighter or darker than the line in the picture.
Negative
A red Control Line but no blue Test Line is a negative result. A negative result means that no Group A
Streptococcus antigen was detected, or the levels of antigen in the specimen were below the detection
level of the assay.
Invalid
If after 5 minutes, no red Control Line appears or background color makes reading the red Control Line
impossible, the result is invalid. If this occurs, repeat the test using a new sample or contact Sekisui
Diagnostics Technical Service.
Notes
A blue or red line that appears uneven in color density is still considered a valid line. In some cases, a trail of
color may remain in the background; as long as the Test Line and Control Line are visible, the results are valid.
CROSS-REACTIVITY
The following organisms tested at levels of approximately 1 x 10
(8)
organisms/test were all found to be
negative when tested with the OSOM Ultra Strep A Test.
Streptococcus Group B Enterococcus faecalis Pseudomonas aeruginosa
Streptococcus Group C Escherichia coli Bordetella pertussis
Streptococcus Group D Staphylococcus aureus Neisseria meningitidis
Streptococcus Group F Staphylococcus epidermidis Neisseria gonorrhoeae
Streptococcus Group G Corynebacterium diptheria Neisseria sicca
Streptococcus pneumoniae Serratia marcescens Neisseria subflava
Streptococcus sanguis Candida albicans Branhamella catarrhalis
Streptococcus mutans Klebsiella pneumoniae Hemophilus influenza
POL STUDIES
An evaluation of the OSOM Ultra Strep A Test was conducted at three physicians offices where testing
was performed by personnel with diverse educational backgrounds. Each site tested the randomly
coded panel consisting of negative (6), low positive (3) and moderate positive (3) specimens for three
days. The results obtained had 100% agreement (108/108) with the expected results.
INTERPRETATION OF TEST RESULTS
Positive