The investigation tested the patient samples for elecsys anti-ccp; the investigation was able to reproduce the customer's results.The investigation tested the patient samples for peptide specificity and streptavidin (sa) interference using reagents with streptavidin and biotin interference-eliminating proteins (ieps).The investigation detected the presence of anti-streptavidin antibodies.The results strongly suggest that the underlying streptavidin interference in the patient samples led to the falsely elevated elecsys anti-ccp assay results.The investigation determined the event was caused by the interfering factor in the patient sample.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation excluded a general product problem.
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