The initial reporter stated they received questionable results for one patient sample tested with the elecsys pth immunoassay and elecsys dhea-s on a cobas 8000 e 801 module.The sample also had a questionable pth value when tested on a second e 801 analyzer.No incorrect results were reported outside of the laboratory.This medwatch will apply to the dhea-s assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the pth assay.The sample initially resulted in a pth value of < 1.5 pg/ml with a data flag when tested on the first e 801 analyzer.The sample was tested again on a second e 801 analyzer, resulting in the same value.The sample was frozen and re-tested approximately 1 week later on an abbott alinity analyzer, resulting in a pth value of 44.1 pg/ml.The sample initially resulted in a dhea-s value of > 1000 ug/dl with a data flag when tested on the first e 801 analyzer.The sample was diluted 1:10 and repeated on the first e 801 analyzer, resulting in a value of approximately 1100 ug/dl.The sample was frozen and re-tested approximately 1 week later on an abbott alinity analyzer, resulting in a dhea-s value of 211.4 ug/dl.The results from the abbott alinity analyzer were believable as these corresponded with the patient's clinical history.The serial number of the first e 801 analyzer is (b)(4).The serial number of the second e 801 analyzer was requested, but not provided.
|
Further investigations of the patient's sample determined that it contains an interfering factor against the streptavidin component of the roche assay.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".
|