Product Manual

FOR IN VITRO DIAGNOSTIC USE
THE FOLLOWING ITEMS ARE NEED TO DO THE TEST:
The OraQuick
®
HCV Rapid Antibody Test Consists of a Divided Pouch Containing the Following:
• Single-Use Test Device (including an absorbent packet) • Developer Solution Vial (containing .750 mL)
NOTE: The pouch is divided into two chambers. One chamber holds the Test Device while the other chamber holds the
Developer Solution Vial.
Materials Provided in the Kit:
• Reusable Test Stands • Specimen Collection Loops
• Package Insert
Materials Required But Not Provided:
• Timer or watch capable of timing 20 to 40 Minutes • Biohazard waste container
• Materials required for venipuncture whole blood • Sterile lancet to obtain a fingerstick whole
specimen collection blood specimen
• OraQuick
®
HCV Visual Reference Panel • OraQuick
®
HCV Rapid Antibody Test Kit Controls
EXTERNAL QUALITY CONTROL
OraQuick
®
HCV Rapid Antibody Test Kit Controls are available separately for use only with OraQuick
®
HCV Rapid Antibody Test. The Kit
Controls are specifically formulated and manufactured to ensure performance of the Test, and are used to verify your ability to properly
perform and test and interpret the results. Refer to the Kit Control Package Insert for complete instructions.
Run the Kit Controls under the following circumstances:
• Each new operator prior to performing testing on patient specimens,
• When opening a new test kit,
• Whenever a new shipment of test kits is received,
• If the temperature of the test kit storage area falls outside of 2
° –30 ° C (36 ° –86 ° F),
• If the temperature of the testing area falls outside of 15
° –37 ° C (59 ° –99 ° F),
• At periodic intervals as dictated by the user facility.
Test Procedure for Kit Controls
1. Open a Kit Control vial containing the control reagent.
2. Insert the rounded end of an unused Specimen Collection Loop into the vial of control reagent. Visually inspect the loop to make sure
that it is completely filled with the control reagent. Use separate unused Specimen Collection Loops for each control reagent.
3. Immediately immerse the control-reagent filled Specimen Collection Loop into the Developer Vial. Use the Specimen Collection Loop to
stir the specimen in the developer solution. Remove the Specimen Collection Loop from the Developer Vial and discard the used loop in
a biohazard waste container.
4. Follow Step 3 Testing Procedure for additional instruction.
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