Rapid Malaria Test Approved
Binax, Incorporated received FDA approval for their lab test that detects the presence of parasites that cause malaria, the Binax Now Malaria Test. The test also identifies the strain of malaria detected. The approval was published on the FDA website.
The easy to use test kit can assess whole blood samples procured with standard venipuncture or a simple finger prick. The blood specimen is applied to a pad that contains anti-malaria antibodies. A liquid reagent is then applied to the blood sample. If malaria is present, the antigens bind to the antibodies. When the reagent is added, the linked antibodies and antigen are captured and two lines are formed on the test kit.
The pad also includes a control line to ensure validity of the test at the point of care. Negative tests only display the colored control line.
The test is designed for use only in patients who are exhibiting symptoms or signs of malaria infection. It can also be used to evaluate people who recently traveled to areas where malaria is endemic. It is not to be used as a screening tool nor is it a tool to monitor ongoing treatment for malaria.
The Binax Now Malaria test represents a solution for areas that have limited access to medical resources, particularly laboratory equipment and personnel. The ability to differentiate disease strains provides clinicians guidance in choosing therapeutic regimens.
August 8, 2007 Related topics: Laboratory, Infectious Diseases, Laboratory Equipment, Diagnostic