OraSure Technologies OraQuick™ ADVANCE™ Kit Controls

The OraQuick™ ADVANCE™ Rapid HIV-1/2 Antibody Test Kit Controls are quality control reagents for use only with the OraQuick™ ADVANCE™ Rapid HIV-1/2 Antiboby Test.

• 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.

Content And Storage

2°C to 8°C

CE Marker

Yes

Disposable

Single-use

Includes

Each Kit Control Box contains a Pk. insert and three vials (one HIV-1 positive control, one HIV-2 positive control and one negative control).