Validation and Performance Evaluation of Biochemical Assays in Pleural Fluid, Ascitic Fluid, and Cerebrospinal Fluid: A Comprehensive Precision, Sensitivity, Accuracy, and Linearity Study

Authors: Jayesh Prabhakar Warade, Ashish Anjankar

DOI: 10.18231/j.ijcbr.13447.1759901703

Keywords: Body fluids, Validation, Diagnostics,sensitivity, accuracy, linearity

Abstract: Background: The validation of biochemical assays in pleural fluid, ascitic fluid, and CSF is essential for accurate diagnosis, disease monitoring, and treatment evaluation. This study aims to assess the precision, sensitivity, accuracy, and linearity of biochemical assays performed on these fluids using various analytes. Objectives: The primary objective of this study is to evaluate the performance characteristics of biochemical assays in pleural fluid, ascitic fluid, and CSF, specifically focusing on precision (CV%), sensitivity (CV% at the lower detection limit), accuracy (recovery rates), and linearity (correlation coefficients). Methods: This in-house validation study utilized a range of analytes, including glucose, cholesterol, triglyceride, albumin, urea, creatinine, total protein, amylase, LDH, ADA, and lipase. The precision of each assay was measured by calculating the CV% at both low and high concentrations. Sensitivity was assessed by evaluating the lowest concentration detectable. Accuracy was determined by calculating recovery rates, while linearity was assessed through correlation coefficients. Results: • Precision: The precision study showed that the CV% for all analytes across the three body fluids was consistently below 5%, with pleural fluid and ascitic fluid demonstrating excellent precision. • Sensitivity: Sensitivity studies confirmed reliable detection limits for the assays, with CV% below 15% for most analytes. • Accuracy: The accuracy study revealed that recovery rates for analytes ranged from 93.5% to 108.6%, indicating strong alignment with expected values. • Linearity: The linearity study demonstrated high correlation coefficients between 0.95 and 1.0 for most analytes across pleural and ascitic fluids, ensuring reliable results even at higher concentrations. Conclusion: This study successfully validates the use of biochemical assays for pleural fluid, ascitic fluid, and CSF. The results indicate that these assays provide reliable and consistent diagnostic information, making them valuable tools for clinicians. The findings support the use of these assays in clinical settings for disease monitoring and treatment response evaluation.