Interpretation Of Results; Quality Control - Gima 24530 Bedienungsanleitung

POSITIVE:* Two distinct colored lines appear. One line should be in the control line region (C) and
another line should be in the test line region (T).
*NOTE: The intensity of color in the test line region (T) will vary depending on the concentration of
Fecal Occult Blood present in the specimen. Therefore, any shade in the test region indicates positive
result.
NEGATIVE: One colored line appears in the control line region (C). No apparent colored line appears
in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the procedure and repeat the test with a new
test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
A procedural control is included in the test. A colored line appearing in the control line region (C) is
considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane
wicking and correct procedural technique. Control standards are not supplied with this kit; however it
is recommended that positive and negative controls be tested as a good laboratory practice to confirm
the test procedure and to verify proper test performance.
1. The FOB One Step Fecal Occult Blood Test Device (Feces) is for in vitro diagnostic use only.
2. The FOB One Step Fecal Occult Blood Test Device (Feces) will only indicate the presence of Fecal
Occult Blood, he presence of blood in feces does not necessarily indicate colorectal bleeding.
3. As with all diagnostic tests, all results must be considered with other clinical information available
to the physician.
4. Other clinically available tests are required if questionable results are obtained.
The FOB One Step Fecal Occult Blood Test Device (Feces) has been compared with another leading
commercial rapid test. The correlation between these two systems is 98%.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

QUALITY CONTROL

LIMITATIONS
EXPECTED VALUES
8