The simple-to-use test offers a very reliable result within minutes of administration and it can be safely stored at room temperature for up to 24 months before use, making it ideal for the OTC market. Chembio intends to seek regulatory approval for this product for the professional market in the U.S. during 2010. Depending on various factors, including the FDA requirements, Chembio intends to begin seeking OTC approval of this product in 2011.