Item Brochure
INTENDED USE
The H. pylori Control Set is intended for in vitro diagnostic use as an unassayed quality control
for the determination of Immunoglobulin G (IgG) antibodies to Helicobacter pylori. This product
should only be used to estimate the precision and monitor the performance of the OSOM
®
H.
pylori Test. The set contains external positive and negative serum controls for qualitative use.
SUMMARY AND PRINCIPLE
The H. pylori Control Set uses a specially formulated matrix to provide satisfactory results when
used with the OSOM
®
H. pylori Test. Although this product does not have assigned values,
positive and negative controls are provided to facilitate monitoring in the expected clinical range.
MATERIALS PROVIDED
• 1 Positive control vial - 2 mL (contains 0.1% sodium azide)
• 1 Negative control vial - 2 mL (contains 0.1% sodium azide)
The control set is provided in liquid form, and is made from processed human serum to which
preservatives, stabilizers, biochemicals and chemicals have been added.
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use only.
• Follow your clinical and/or laboratory safety guidelines in the collection, handling, storage
and disposal of samples or reagents.
• Handle all controls and materials used in testing as biohazards in the same manner as
patient specimens.
• The human serum used to make this product was tested by currently approved methods
and found non-reactive for hepatitis B surface antigens (HbsAg), HIV1, HIV2 and HCV
antibodies. Currently there is no test method that can assure that human blood used in this
product will not transmit infectious agents.
• The Control set contains sodium azide as a preservative. If control solution comes in
contact with the skin or eyes, flush with ample volumes of water.
• Solutions that contain sodium azide may react explosively with lead or copper plumbing.
Use large quantities of water to flush discarded solutions down a sink.
STORAGE AND STABILITY
• The H. pylori Control vials should be kept tightly closed after opening to avoid evaporation.
• Store vials upright at 2°-8°C (36°- 46°F).
• Do not freeze.
• The H. pylori Controls are stable until the expiration date printed on the vial label.
PROCEDURE
Use the H. pylori Controls as you would a patient sample in accordance with the procedure for
the OSOM H. pylori Test. Read the procedural instructions from the OSOM H. pylori product.
1. Allow the H. pylori Controls to reach room temperature prior to use.
2. Gently invert the vial 5-10 times to assure complete mixing.
3. Positive Control - Remove the cap from the positive control vial. Dispense 1 drop of
positive control material into the device sample. Replace the cap.
4. Negative Control - Remove the cap from the negative control vial. Dispense 1 drop of
negative control material into another device sample well. Replace the cap.
5. Follow the test procedure as directed in the OSOM H. pylori package insert.
H. pylori Control Set