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INTERPRETATION OF TEST RESULTS
Note:A blue or red line which appears uneven in color density is considered a valid result. In cases of
moderate or high positive specimens, some blue color behind the Test Line may be seen; as long
as the Test Line and Control Line are visible, the results are valid.
Positive
A blue Test Line and a red Control Line is a positive result for the detection of Group A Streptococcus
antigen. 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 presumptive negative result.
Invalid
If 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 on a new Test Stick or contact Sekisui Diagnostics
Technical Service.
POL STUDIES
An evaluation of the OSOM Strep A Test was conducted at three physicians ofces 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 >99% agreement (107/108) with the expected results.
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 Strep A Test.
Streptococcus Group B
Streptococcus Group C
Streptococcus Group F
Streptococcus Group G
Streptococcus pneumoniae
Streptococcus sanguis
Streptococcus mutans
Enterococcus faecalis
Staphylococcus aureus
Staphylococcus epidermidis
Corynebacterium diptheria
Serratia marcescens
Candida albicans
Klebsiella pneumoniae
Pseudomonas aeruginosa
Bordetella pertussis
Neisseria meningitidis
Neisseria gonorrhoeae
Neisseria sicca
Neisseria subflava
Branhamella catarrhalis
Hemophilus influenza
1 min 5 min
• Let stand for 1 minute.
Express as much liquid as possible from the swab
by squeezing the sides of the tube as the swab
is withdrawn.Discard the swab.
Remove Test Stick(s) from the container;
re-cap container immediately.
Place the Absorbent End of the Test Stick into
the extracted sample.
Read results at 5 minutes. Positive results may
be read as soon as the red Control Line appears.
Results are invalid after the stated read time.
The use of a timer is recommended.