Description
Regulatory Status: CLIA Waived for Oral Fluid Whole Blood
Contents: (1) Package Insert, (1) Positive Control and (1) Negative Control
Storage Requirements: 2° – 8° C (35°-46° F)
Processing Time: 20 Minutes
The OraQuick® HCV Rapid Antibody Test Kit Controls are human plasma-based reagents. The Kit Controls are specifically formulated and manufactured to ensure proper performance of the test. The HCV Positive Control will produce a reactive reddish-purple line at the Test (T) Zone. The HCV Negative Control will generate a non-reactive test result (no reddish-purple line at the Test (T) Zone). Refer to Test Result and Interpretation of Test Result section of the OraQuick® HCV Rapid Antibody Test package insert. Use of kit control reagents manufactured by any other source will not meet the requirements for an adequate quality assurance program for the OraQuick® HCV Rapid Antibody Test.
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