Siemens healthcare diagnostics investigation into elevated advia centaur xp afp results on one patient is complete.The patient being tested was not previously positive for non-seminomatous testicular cancer.The intended use of afp is to monitor patients that have been diagnosed with non-seminomatous testicular cancer and elevated results can be seen with other malignant and non malignant conditions.This patient does not appear to fit with the intended use of the assay.The instructions for use (ifu) intended use section states, "for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in the following: as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the advia centaur® xp and advia centaur xpt® systems." the instructions for use (ifu) warnings states, "the advia centaur afp assay is not a screening test for cancer and must never be used as such.Afp testing is a safe and effective supplement to patient care when used as part of the overall management strategy for patients undergoing treatment for non-seminomatous testicular cancer or for patients being monitored after therapy is complete.Do not interpret serum afp as absolute evidence of the presence of malignant disease.At time of presentation, patients with confirmed non-seminomatous testicular cancer may have serum afp concentrations within the range observed in healthy individuals.Since elevated afp levels are often found in patients with other malignant and non-malignant conditions, the physician should rule out all other conditions associated with elevated afp levels prior to the use of the advia centaur afp values in non-seminomatous testicular cancer management." there is no product non conformance identified and customer has reported no further elevated results.No further action required.
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