The cause for the falsely elevated advia centaur xp ca 19-9 result is unknown.The customer's quality control results were all acceptable at the time of the event.The ca 19-9 dilution results indicate a nonlinear response, and possible unknown interferent elevating the centaur ca 19-9 results.There is no sample available for further evaluation.No conclusion can be drawn.The limitations section of the instructions for use (ifu) states: "warning" "do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca 19-9.Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease." "note" "do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." "the concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay specific values to evaluate quality control results." "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.".
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A falsely elevated advia centaur xp ca 19-9 result was obtained by the customer.Due to the elevated ca 19-9 result, the patient sample was diluted, retested, and the results were elevated.The customer performed repeat ca 19-9 testing on two alternate test methods and the results were lower.A final lower ca 19-9 result was reported.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp ca 19-9 result.
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