The cause for the discordant afp result is unknown.
Siemens healthcare diagnostics is investigating.
The warning section of the instructions for use states: "warning the concentration of afp in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.
The results reported by the laboratory to the physician must include the identity of the afp assay used.
Values obtained with different afp assay methods cannot be used interchangeably.
Before changing assay methods, the laboratory must do the following: for prenatal testing, the laboratory must establish a range of normal values for the new assay based on normal serum and amniotic fluid from pregnant women with a confirmed gestational age.
For cancer management, the laboratory must perform additional testing to confirm baseline values for patients being serially monitored.
United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
Use afp results only as part of the overall clinical evaluation of a patient.
Do not use afp results as the only criterion for diagnosis.
" the interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.
".
|