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Quidel Quickvue IFOB Control Set

Item # QCKV-CTRLS | SKU # 20197

Quidel Quickvue IFOB Control Set

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Quidel Quickvue IFOB Control Set

Item # QCKV-CTRLS | SKU # 20197

Price: $49.95

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

  • One (1) vial (2.0 mL) Negative Control: Contains buffered solution, with 0.02% sodium azide as preservative.
  • One (1) vial (2.0 mL) Positive Control: Contains hemoglobin of human origin in buffered solution, with 0.02% sodium azide as preservative.
  • Package Insert (1)

MATERIALS REQUIRED BUT NOT PROVIDED

  • QuickVue iFOB test cassette
  • Timer or watch

Model No. 20197

WARNINGS AND PRECAUTIONS

  • For In-Vitro Diagnostic Use.
  • Do not use beyond labeled expiration date marked on the outer kit label. ? Do not interchange the caps with those of other reagent bottles.
  • Dispose of containers and used contents in accordance with Federal, State, and Local requirements. 
  • Use of Nitrile or Latex gloves is recommended when working with these controls.
  • Follow proper hand washing hygiene after handling these controls.
  • The External Controls are designed for use only with the QuickVue iFOB test.

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

  • All Test Cassettes and control reagent vials must be at room temperature before beginning the test.
  • Remove the Test Cassette from the pouch and place it on a clean, flat, dry, level surface. ? Remove the control reagent vial screw cap by turning.
  • Dispense six (6) drops of either the Positive or Negative control reagent into the Sample Well.
  • READ RESULTS AT 5–10 MINUTES. Some positive results may be seen earlier. IMPORTANT: Do not read the test results after ten (10) minutes.
 
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