Volume: 43 Issue: 1
Year: 2023, Page: 462-468, Doi: https://doi.org/10.51248/.v43i01.1808
Introduction and Aim: In today's world, laboratories are a crucial aspect of health-care services, and the biochemistry section contributes the most testing parameters. To our knowledge, this is the first attempt to verify and validate a pooled TSH reagent kit. The present study is aimed to pool and validate the pooled TSH reagent kit for testing and compare its performance with the intact manufactured supplied reagent kit.
Materials and Methods: Performed in a medium-sized biochemistry laboratory with a daily sample load of 1000-1200. Before disposal, the TSH reagent with the available dead-volume was pooled in a new kit. We gathered three used TSH reagent kits from the same lot series and pooled the dead-volume to generate one functioning reagent. Before assessing the analytical performance of pooled TSH reagent, this was placed onto the instrument, calibrated, and Quality control ran. The CLIA procedure for testing method specification was used to evaluate the reagent's performance, which included accuracy, precision, measurement range, reference range, recovery, interference, and method comparison.
Results: With a high degree of analytical precision, the obtained reference range was within the manufacturer's range (r2=0.99). Precision was comparable with the manufacturer claim; inter-assay variation (1.90% CV), Intra-assay variation (1.50% CV) and overall (1.33% CV). AMR found to be as true as established by the manufacturer - 0.005-100 μIU/mL. Internal quality control performance; level 2 & level 3 variations of 1.58% and 1.20% respectively.
Conclusion: A pooled TSH reagent was precise, accurate as compared to the manufacturer Reagent kit. This will reduce the number of the reagent procurement by the laboratory with documented high kit utility rate (Kit efficiency Index) ranging between 90-100%.
Keywords: Validation; Verification; Analytical Measuring Range (AMR); Clinical biochemistry laboratory; Pooled Reagent Kit.
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Anurag Yadav, Ramlinga Reddy, Avinash S.S, Malathi M., Anmol Manaswini Yadav, Nanda Kumar L.G. Yadav. Analytical method validation of pooled TSH reagent in clinical biochemistry laboratory. Biomedicine: 2023; 43(1): 462-468