Interference No. 103,891
shown. These include a swab, an extraction tube-–where reagent
and specimen mixing occurs, three numbered reagents, and a
reaction disc. The reaction disc is generally square and has a
sample window in which the specimen-reagent mix is placed.
Taking up a major portion of the disc’s surface is the area
containing the various windows of the test. In the central
portion of the disc there is a results window. To the right of
this window are two smaller windows one above the other. The top
small window is the positive control window; the lower small
window is the negative control window. Diagonally across from
the sample window where the specimen is introduced, in the other
corner of the disc, is the end of assay window. The procedure
for use of the Concept S kit is shown on the next page of FX-1.
The last page of FX-1 is a description of how the
Concept S test results would be interpreted. Simply put, if an
indication appears in the upper small window beside the results
window but not in the lower small window beside the results
window, the test was performed accurately, whether the test
results are indicated as positive or negative. If two indica-
tions appear in both small windows, the test is falsely positive.
If no indications appear in the two small windows, the test is a
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