The sample was submitted for investigation.The customer's he4 results were reproduced on an e601 module (278 pmol/l).Dilution and spiking experiments were performed and the sample underwent heterophilic blocking tube (hbt) treatment; the results received did not indicate the presence of an interfering substance.The sample underwent polyethylene glycol (peg) treatment; the results suggest the presence of an interfering substance, however, the results generated do not explain the difference in results between the roche method and the abbott method.Further clarification of the root cause for the differences between the roche and abbott results is not possible with available methods and the current state of the art.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." the investigation did not identify a product problem.The reagent performs within specification.A general reagent issue can be excluded.
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