Differences between the ft4 results generated with the different analyzers are caused by differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.From the information provided and the analysis of the sample, a general reagent issue could be excluded.
|
The initial reporter received questionable elecsys ft4 iii assay results on a cobas e 801 module.On (b)(6) 2022, the initial ft4 result was 1.94 ng/dl.The result was reported outside of the laboratory.The physician questioned the result as it did not fit the patient's clinical picture.On (b)(6) 2022, the sample was repeated on an abbott architect analyzer.The ft4 result was 1.33 ng/dl.It is not known which result was deemed correct.The reagent lot and expiration date were requested but not provided.This medwatch covers ft4 iii.Refer to the medwatch with patient identifier (b)(6) for information on the tsh results.
|