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Item # QCKV-CTRLS | SKU # 20197
With Approximately 7 tests per bottle, our Quidel Quickvue Positive and Negative Liquid iFOB Control Set is for use with QuickVue iFOB Test kit only. Room temperature storage.
The QuickVue iFOB Control Set is intended for use with the QuickVue iFOB test (immunochemical Fecal Occult Blood Test). These controls provide an aid in the interpretation of positive and negative test results and verify proper test performance.
The QuickVue iFOB Control Set contains two vials – one negative and one positive – for use in verifying the performance of the QuickVue iFOB test. Elevated levels (50 ng hHb/mL buffer or 50 µg hHb/g feces) of human hemoglobin are an indication of gastrointestinal disorders such as diverticulitis, colitis, and polyps, which may lead to colorectal cancer if not treated.
When used as qualitative controls in place of patient specimen, the results may aid in the interpretation of positive and negative results and verify test performance.
The QuickVue iFOB Control Set is designed for use as external qualitative control samples when used in accordance with the QuickVue iFOB test package insert procedure.
REAGENTS AND MATERIALS SUPPLIED
MATERIALS REQUIRED BUT NOT PROVIDED
Model No. 20197
WARNINGS AND PRECAUTIONS
STABILITY AND STORAGE
Store the QuickVue iFOB test Control Set at room temperature 59–86°F (15–30°C). Do not freeze. The contents can be used until the expiration date printed on the outer box, or four (4) weeks after the vials are opened, whichever occurs first.
QUALITY CONTROL
External controls may be used to demonstrate that all reagents and assays are performing properly. The QuickVue iFOB Control Set, when used in accordance with the test procedure described in the QuickVue iFOB test package insert, provide this capability.
TEST PROCEDURE
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