The customer provided the patient's sample for an investigation.The investigation tested the patient's sample on a cobas e 411 immunoassay analyzer and had the following results: elecsys cmv igm: 3.14 coi reactive.Elecsys cmv igg: 1.0 u/ml reactive.The investigation could not confirm the customer's cmv igg results.The investigation reviewed the customer's provided qc results and the results were within the acceptable range.However, there were no qc results provided on the date of the event.Per product labeling, "the measured cmv igg value of a patient¿s sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the cmv igg assay method used.Cmv igg values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.Therefore, the results reported by the laboratory to the physician should include: "the following results were obtained with the elecsys cmv igg assay.Results from assays of other manufacturers cannot be used interchangeably." for borderline results, product labeling states, "re-test the sample, collect another sample within 2 weeks or test with an alternative method." the investigation is ongoing.
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