A novel semi-automated method for urine protein assay associated with calculation of sigma metric
Introduction: a novel semi-automated method for urine protein assay was introduced, validated and also analytical performance evaluation was conducted for the clinical laboratories practice. Materials and method: Introduced method was calibrated based on multipoint calibration with human based biochemistry calibrator. All of the method validation procedure was done according to the CLSI guidance. Finally, total error, sigma metric and performance of quality was evaluated. Results: Results indicate the good correlation with Biuret and pyrogallol-red methods in ranging from 0.33 to 6760 mg/dl. Method was linear up to 6760 mg/dl and was highly sensitive compared to pyrogallol-red method. Based on sigma scale, introduced method have good performance in broad measuring range and based on comparison practice, sigma was >6 in all decision levels for urine protein concentration. Conclusion: In conclusion, novel semi-automated method can be selected as preferred method in reference laboratory. Also, IVD manufacturers can use sigma scale results to improve diagnostic products.
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