Yoseph Cherinet Megerssa1, Fikru Regassa Gari2, Fanos Tadesse Woldemariyam2,3. 1. Department of Biomedical Sciences, College of Veterinary Medicine and Agriculture, Addis Ababa University, Addis Ababa, Ethiopia. yoseph.cherinet@aau.edu.et. 2. Department of Biomedical Sciences, College of Veterinary Medicine and Agriculture, Addis Ababa University, Addis Ababa, Ethiopia. 3. Department of Biosystems, Division of Animal and Human Health Engineering, Laboratory of Host-Pathogen interaction, KU Leuven, Leuven, Belgium.
Abstract
OBJECTIVE: Validation of a test method is critical for confirming that the test can generate accurate and precise data. Although commercial biochemical test kits exist there are no specific and validated commercial clinical chemistry test kits designed for horses. The aim of this study was to validate commercial clinical chemistry test kits designed for a human serum for use in horses. RESULTS: Blood samples were collected from 29 apparently healthy adult male horses and pooled serum was prepared. Validation comprises replication and recovery experiments. Total observable error (TEo), sigma (σ) metrics, and quality goal index (QGI) were used to support the validation studies. Intra- and inter-assay variability was 2.05% and 2.08%, 2.26% and 1.89%, 2.4% and 1.63%, for total cholesterol, urea and total protein, respectively; recovery was 99.46%, 97.32%, and 100.1% for total cholesterol, urea and total protein, respectively. TEo% for the specified analytes was within the total allowable error (TEa). All three analytes satisfied the recommended requirement (> 3σ). The QGI for urea, as it had below 6σ was 0.95 indicating imprecision and inaccuracy. The results endorse the suitability of the studied commercial test kits and illustrated the acceptance criteria for horse's serum.
OBJECTIVE: Validation of a test method is critical for confirming that the test can generate accurate and precise data. Although commercial biochemical test kits exist there are no specific and validated commercial clinical chemistry test kits designed for horses. The aim of this study was to validate commercial clinical chemistry test kits designed for a human serum for use in horses. RESULTS: Blood samples were collected from 29 apparently healthy adult male horses and pooled serum was prepared. Validation comprises replication and recovery experiments. Total observable error (TEo), sigma (σ) metrics, and quality goal index (QGI) were used to support the validation studies. Intra- and inter-assay variability was 2.05% and 2.08%, 2.26% and 1.89%, 2.4% and 1.63%, for total cholesterol, urea and total protein, respectively; recovery was 99.46%, 97.32%, and 100.1% for total cholesterol, urea and total protein, respectively. TEo% for the specified analytes was within the total allowable error (TEa). All three analytes satisfied the recommended requirement (> 3σ). The QGI for urea, as it had below 6σ was 0.95 indicating imprecision and inaccuracy. The results endorse the suitability of the studied commercial test kits and illustrated the acceptance criteria for horse's serum.
Authors: Jean W Lee; Viswanath Devanarayan; Yu Chen Barrett; Russell Weiner; John Allinson; Scott Fountain; Stephen Keller; Ira Weinryb; Marie Green; Larry Duan; James A Rogers; Robert Millham; Peter J O'Brien; Jeff Sailstad; Masood Khan; Chad Ray; John A Wagner Journal: Pharm Res Date: 2006-01-12 Impact factor: 4.200
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