General Information
Revision date
2014-02-21
Product name
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Kit Controls
1.2.1 Relevant identified uses
OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit Controls are human plasma-based reagents. 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 interpret the results. The HIV-1 and HIV-2 Positive Controls will produce a reactive test result and have been
Manufacturer Name
OraSure Technologies, Inc
Emergency telephone
1-800-535-5053, +1-352-323-3500
Icons in SDS
Company Information
company name
OraSure Technologies, Inc
Section 2
SECTION 2: Hazards identification
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit Controls individual components should be used only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. NOTE: Handling, storing or shipping of the complete packaged product should pose no threat to the individual. If no leak or excessive damage is noted there is no recommended Personal Protective Equipment (PPE) required. If the products’ integrity is in question due to excessive damage or unforeseen circumstances, utilize proper safety procedures and handle using universal precautions including PPE (safety glasses/face protection and gloves) as per 29 CFR 1910.1030. Components
Contains
1 vial of 0.75ml HIV-1 Positive 0.2ml BPUV treated human plasma, positive for HIV-1 antibodies, diluted in a defibrinated pool of human Control (Black Cap) plasma. Preservative: ProClin 5000. 1 vial of 0.75ml HIV-2 Positive 0.2ml BPUV treated human plasma, positive for HIV-2 antibodies, diluted in a defibrinated pool of human Control (Red Cap) plasma. Preservative: ProClin 5000. 1 vial of 0.75ml Negative Control 0.2ml of defibrinated pool of human plasma negative for HIV-1 & HIV-2. Preservative: ProClin 5000. (White Cap) COMMENTS: The Positive Control (black capped vial) contains 0.2ml of photochemically inactivated human plasma positive for antibodies to HIV-1, diluted in a defribrinated pool of human plasma. The Positive Control (red capped vial) contains 0.2ml of photo chemically inactivated human plasma positive for antibodies to HIV-2, diluted in a defribrinated pool of human plasma. The Negative Control (white capped vial) contains 0.2ml of defribrinated pool of human plasma negative for antibodies to HIV-1 and HIV-2. All control vials contain the chemical ProClin 5000 as a preservative. All control vials are negative for Hepatitis B surface antigen and Hepatitis C antibody. The vials contain no known active viruses; the test indication is based on the response to the antibody only.
