Potential biohazardous materials:
The calibrator and controls contain human source components, which have been tested and found non-reactive for hepatitis B surface antigen as well as HIV antibody with FDA licensed reagents. However, as there is no test method that can offer complete assurance that HIV, Hepatitis B virus or other infectious agents are absent, these reagents should be handled at the Biosafety Level 2, as recommended in the Centers for Disease Control/National Institutes of Health manual, "Biosafety in Microbiological and Biomedical Laboratories." 1984
This test kit is designed for Research Use Only.
Do not pipette by mouth. Do not smoke, eat, or drink in the areas in which specimens or kit reagents are handled.
The components in this kit are intended for use as an integral unit. The components of different lots should not be mixed.
It is recommended that serum samples be run in duplicate.
Optimal results will be obtained by strict adherence to this protocol. Accurate and precise pipetting, as well as following the exact time and temperature requirements prescribed are essential. Any deviation from this may yield invalid data.