The cause for the non-reproduced discordant advia centaur xp rubella g (rub g) result obtained on a patient sample cannot be determined.The customer's rubella g calibration and quality control (qc) were acceptable, and the sample dispense well was clear.Pre-analytical factors cannot be ruled out, and variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.There were no other similar complaints for rubella g reagent lot 068204 on review.Based on the available information, rubella igg lot 068204 is performing as intended.The instruction for use (ifu) under the interpretation of results states the following: "samples with a calculated value of less than 5.0 iu/ml are considered negative for igg antibodies to rubella virus." "samples with a calculated value greater than or equal to 5.0 iu/ml and less than or equal to 9.9 iu/ml are considered equivocal for igg antibodies to rubella virus.Obtain a new specimen and test using the advia centaur rubella g assay." "samples with a calculated value greater than or equal to 10.0 iu/ml are considered positive for igg antibodies to rubella virus." the instrument is performing within specification.No further evaluation of the device is required.
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A false positive advia centaur xp rubella g (rub g) result was obtained on a patient sample, and the result was questioned by the physician based on the patient's negative rubella g test history.A second sample was tested by the customer, and the rubella g result was equivocal.The original sample was retested, and the rubella g result was equivocal.A corrected report was issued by the customer.There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive advia centaur xp rubella igg result.
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