Directions For Use - Gima 24530 Bedienungsanleitung

7
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is
stable through the expiration date printed on the sealed pouch. The test must remain in the sealed
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
• Specimens should not be collected during or within three days of a menstrual period, or if the patient
suffers from bleeding hemorrhoids or blood in the urine.
• Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation resulting
in occult bleeding. Such substances should be discontinued at least 48 hours prior to testing.
• No dietary restrictions are necessary before using the FOB One Step Fecal Occult Blood Test Device
(Feces).
MATERIALS
Materials Provided
• Test devices
• Specimen collection tubes with extraction buffer
• Package insert
Materials Required But Not Provided
• Specimen collection container
• Timer

DIRECTIONS FOR USE

Allow test, specimen collection tube, specimen, and/or controls to equilibrate to room temperature
(15-30°C) prior to testing.
1. To collect fecal specimens: Collect feces in a clean, dry specimen collection container. Best results
will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be
stored for 3 days at 2-8°C if not tested within 6 hours.
2. To process fecal specimens: Unscrew the cap of the specimen collection tube, then randomly stab
the specimen collection stick into the fecal specimen in at least 3 different sites. Do not scoop the fecal
specimen. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen
collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the
specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
3. Remove the test device from the sealed pouch and use it as soon as possible.
4. Hold the specimen collection tube upright and break off the tip of the specimen collection tube.
Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approx. 90µL)
to the specimen well (S) of the test device, then start the timer. Avoid trapping air bubbles in the
specimen well (S). See illustration below.
5. Wait for the colored line(s) to appear.Read results at 5 minutes. Do not interpret the result after 10
minutes.