The Trials of Testosterone TestingImmunoassays Faulty in Women and Children, But What's the Solution?By Genna Rollins
Testosterone measurements by direct immunoassays are unreliable at low concentrations, particularly in women and children. Now industry leaders have issued a call-to-action to improve and standardize the tests.
Lab Compliance ProgramsWhat Does it Take to Stay Out of Trouble?By Bill Malone
In a post-healthcare reform new era of high scrutiny and aggressive investigation, a good compliance program is key for labs. Labs that do not have a program in place now will be under the gun to develop one, as language buried in the healthcare reform law has made such initiatives mandatory. For labs that already have a compliance program, experts are warning that new federal initiatives will require labs to move into high gear in this area, and merely token efforts will leave a lab exposed.
Multiple MyelomaLaboratory Testing for Plasma Cell Proliferative ProcessesBy David F. Keren, MD
Multiple myeloma, a highly lethal neoplasm of plasma cells, was the first disease for which the clinical laboratory could measure a quantifiable tumor marker, the Bence Jones protein. Today, the Bence Jones protein and related monoclonal (M) protein markers are extremely important for detecting, classifying, staging, and monitoring multiple myeloma.
News from the FDA
Download the entire issue
FDA Moves on Lab-Developed Tests
Mass Spectrometry: Ready for Routine Use?