OraSure Technologies OraQuick™ ADVANCE™ Kit Controls

Description

• Each Kit Control Box contains a package insert and three vials (one HIV-1 positive control, one HIV-2 positive control and one negative control)
• Store the controls at 2 to 8 degrees C (35 to 46 degrees F)
• One black-capped vial containing 0.2 mL of photochemically inactivated human plasma positive for antibodies to HIV-1, diluted in a defibrinated pool of normal human plasma
• One red-capped vial containing 0.2 mL of photochemically inactivated human plasma positive for antibodies to HIV-2, diluted in a defibrinated pool of normal human plasma
• One white-capped vial containing 0.2 mL of photochemically inactivated human plasma negative for antibodies to HIV-1 and HIV-2
• Negative for Hepatitis B surface antigen and Hepatitis C antibody
• Run the Kit Controls under the following circumstances: Each new operator prior to performing testing on patient specimens When opening a new test kit lot Whenever a new shipment of test kits is received If the temperature of the test kit storage area falls outside of 2-27°C (36-80°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.