Product Manual

WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use only.
•
Do not interchange materials from different product lots and do not use beyond the
expiration date.
• Use separate clean capillary tubes for different specimens. Do not pipette by mouth.
• Do not smoke, eat or drink in areas in which specimens or kit reagents are handled.
•
Wear disposable gloves while handling kit reagents or specimens and thoroughly wash
hands afterwards.
• All patient samples should be handled as if they were capable of transmitting disease.
O
bserve established precautions against microbiological hazard throughout all proce-
dures and follow the standard procedures for proper disposal of specimens.
• Developer solution in this kit contains sodium azide as a preservative, which may react
with lead or copper in plumbing to form potentially explosive metal azides. Upon dis-
p
osal, always flush with a large volume of water to prevent azide buildup in drains.
• The OSOM H. pylori device should remain in its original sealed pouch until ready for use.
Do not use the test if the pouch is damaged.
S
TORAGE AND STABILITY
The OSOM H. pylori Test kit should be stored at 2–30°C (36–86°F) in the original sealed
pouch. The storage conditions and stability dating given were established under these
c
onditions. The kit is stable until the expiration date.
SPECIMEN COLLECTION AND PREPARATION
• Anticoagulated Whole Blood: Whole blood collected over sodium heparin, lithium
heparin, citrate or EDTA can be used. Mix whole blood by inversion and use in the test
as outlined in the Test Procedure.
• Fingertip Whole Blood: Prick the finger and collect the blood in a capillary tube
to the 25 µL mark. Follow the Test Procedure.
• Serum: Collect blood sample into a tube containing no anticoagulant. Allow the
blood to clot at room temperature (18–30°C) and then centrifuge at 1500 x g for
ten minutes at room temperature.
• Plasma: Collect whole blood sample into a tube containing anticoagulant such as
CPDA-1, heparin, or EDTA.
• When collecting sample hold capillary tube so that black line (25 uL whole blood) or
red line (10uL serum or plasma) is at the bottom.
• Remove the serum or plasma from the blood cells as soon as possible to avoid hemolysis.
When possible, clear, non-hemolyzed specimens should be used. Mildly hemolyzed
samples do not affect the test result, but will create an undesirable reddish back-
ground in the Result window.
• Specimens containing any particulate matter may give inconsistent test results. Such
specimens should be clarified by centrifugation prior to testing.
• Refrigerate all specimens at 2–8°C until ready for testing. If serum or plasma specimens
will not be tested within 48 hours, they should be frozen and stored at -20°C or below.
Specimens should not be repeatedly frozen and thawed.
• Bring samples to room temperature (18–30°C) before testing. Frozen samples must be
completely thawed, thoroughly mixed, and brought to room temperature prior to testing.
• If specimens are to be shipped, they should be packed in compliance with Federal
and carrier regulations covering transportation of etiologic agents.
PROCEDURE
Procedural Notes
• Allow specimens and the OSOM H. pylori Test kit to warm to room temperature
(18–30°C) before testing.
• Do not open the sealed pouch until you are ready to perform the test.
• Several tests may be run at one time.
• Do not reuse a lancet.
• To avoid cross-contamination, use a new capillary tube for each specimen.
• To avoid contamination, do not touch the tip of the Developer solution dropper bottle
to skin or to the test device.
• Label the device with the patient’s name or control number.
• When adding the Developer solution, hold the dropper bottle in a vertical position
above the lower area of the Sample well (S).
• After testing, dispose of the OSOM H. pylori Test and the specimen dispenser or
capillary tube following good laboratory practices. Consider each material that
comes in contact with the specimen to be potentially infectious.