The initial reporter questioned thyroid results for 1 patient sample tested on a cobas 8000 e 801 module compared to an accuraseed analyzer.Based on the data provided, the elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results were discrepant between the accuraseed analyzer and the customer's e 801 module.The customer questioned the anti-tshr results from the yamasa method.The sample was submitted for investigation where discrepant elecsys anti-tshr immunoassay results were identified between the yamasa method and an e801 module used at the investigation site.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the ft4 iii results, and medwatch with patient identifier (b)(6) for information on the ft3 iii results.The initial results from the e 801 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.
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Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.Product labeling states "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".
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