The customer observed a correlation difference of result between the advia centaur xpt ca 19-9 assay compared to an alternate ca 19-9 test method (tosoh) previously used by the customer.The customer tested the patient sample on a second alternate ca 19-9 test method (beckman) which produced a higher result compared to the advia centaur xpt ca 19-9 assay.There are no apparent issues with the customer's advia centaur xpt ca 19-9 assay calibrations.The patient sample is not available for further investigation.The instruction for use (ifu) under the warning section states the following: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values." the instruction for use (ifu) under the intended use section states the following: "the advia centaur® ca 19-9 assay is an in vitro immunoassay for the quantitative measurement of the ca 19-9 tumor-associated antigen, in human serum, using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay is indicated for the serial measurement of ca 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum ca 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.Ca 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined." the instrument is performing within specifications.No further evaluation of the device is required.There were other patient correlation runs performed where the advia centaur xpt results were lower (refer to mdr 1219913-2017-00230, mdr 1219913-2017-00231, mdr 1219913-2017-00233, and mdr 1219913-2017-00234).
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