Objectives Body fluid specimens other than serum, plasma or urine are generally not validated by manufacturers, but analysis of these non-standard fluids can be important for clinical diagnosis and management. Laboratories, therefore, rely on the published literature to better understand the validation and implementation of such tests. This study utilized a data-driven approach to determine the clinical reportable range for 11 analytes, evaluated a total bilirubin assay, and assessed interferences from hemolysis, icterus, and lipemia in non-standard fluids. Design and methods Historical measurements in non-standard body fluids run on a Beckman Coulter DxC800 were used to optimize population-specific clinical reportable ranges for albumin, amylase, creatinine, glucose, lactate dehydrogenase, lipase, total bilirubin, total cholesterol, total protein, triglyceride and urea nitrogen run on the Beckman Coulter AU680. For these 11 analytes, interference studies were performed by spiking hemolysate, bilirubin, or Intralipid? into abnormal serous fluids. Precision, accuracy, linearity, and stability of total bilirubin in non-standard fluids was evaluated on the Beckman Coulter AU680 analyzer. Results The historical non-standard fluid results indicated that in order to report a numeric result, 4 assays required no dilution, 5 assays required onboard dilutions and 2 assays required both onboard and manual dilutions. The AU680 total bilirubin assay is suitable for clinical testing of non-standard fluids. Interference studies revealed that of the 11 total AU680 analyte measurements on non-standard fluids, lipemia affected 1, icterus affected 3, and hemolysis affected 5. Conclusions Chemistry analytes measured on the AU680 demonstrate acceptable analytical performance for non-standard fluids. Common endogenous interference from lipemia, icterus, and hemolysis (LIH) are observed and flagging rules based on LIH indices were developed to help improve the clinical interpretation of results. Highlights ? A data-driven approach was used to optimize clinical reportable ranges for non-standard fluid analytes. ? Performance characteristics for the Beckman Coulter AU680 total bilirubin for non-standard fluids were established. ? Pre-analytical interference from lipemia, icterus, and hemolysis is appreciable in non-standard fluids.
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