A siemens field service engineer (fse) was sent to the customer site for system inspection.No issues were identified.The advia centaur xp repeat (b)(6) results were reported out before the supplemental testing results were provided.The physician provided antiviral medication based on the advia centaur xp results and did not wait for all of the necessary results to be provided.The cause for the discordant advia centaur xp chiv results is unknown.There is no sample available for additional testing and investigation.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.-specimens with an index value greater than or equal to 1.0 are considered initially (b)(6) and should be retested in duplicate after centrifugation at 10,000 x g for 10 minutes.If one or both of the duplicates are reactive, the specimen is repeatedly (b)(6) by the advia centaur chiv assay.Note inadequate centrifugation may result in a higher rate of repeat reactive results that must be investigated using supplemental tests for (b)(6) antigen.-repeatedly (b)(6) specimens must be investigated using supplemental tests for (b)(6) antigen.In specimens giving indeterminate supplemental test results, testing of a subsequent sample drawn at a later date (such as 1-6 months) is recommended.For individuals who are confirmed (b)(6) for antibodies and/or (b)(6) antigen, appropriate counseling and medical evaluation should be offered and is considered an important part of testing for antibody to (b)(6) antigen.".
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