IVD Technology
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Originally published September, 1997
FDA advisory notices
In July, 1997, FDA's Center for Devices and Radiological Health (CDRH) issued two public health advisories relating to the use of diagnostics for toxoplasmosis and Lyme disease. Both advisories resulted from recommendations of the device center's microbiology devices advisory panel.
Noting that FDA has "recently become aware of inaccurate test results from clinical reference laboratories," the toxoplasmosis advisory instructs physicians that they "should not use the result from any one Toxoplasma IgM commercial test kit as the sole determinant of recent Toxoplasma infection when screening a pregnant patient." An algorithm is provided for the interpretation of test results. The agency is now working with test-kit manufacturers to provide appropriate labeling information.
The Lyme disease advisory observes that "the results of assays for detecting antibody to Borrelia burgdorferi (anti-Bb) "may be easily misinterpreted." It advises physicians to base their diagnoses on the patient's history, physical findings, and laboratory data other than anti-Bb results. A two-step algorithm is provided for interpretation of test results.
The full text of both advisories is available on the device center's Web site, http://www.fda.gov/cdrh.
