Original article / research
Year : 2025 Month : January Volume : 14 Issue : 1 Page : BO01 - BO06 Full Version

Comparison of Analytical Performance of Dry Chemistry Analysers Vitros 5600 and Vitros 250: A Cross-sectional Study
Edakkadath Raghavan Sindhu, Emilin Zacharias, Keezhpally Soman Mini, Therayangalath Bindu, Padippurayil Faizal, Thekkoottuparambil Ananthanarayanan Ajith
1. Assistant Professor, Division of Biochemistry, Malabar Cancer Centre, Kannur, Kerala, India. 2. Biochemist, Division of Biochemistry, Malabar Cancer Centre, Kannur, Kerala, India. 3. Lab Technologist, Division of Biochemistry, Malabar Cancer Centre, Kannur, Kerala, India. 4. Lecturer, Department of Cancer Registry and Epidemiology, Malabar Cancer Centre, Kannur, Kerala, India. 5. Assistant Professor, Division of Biochemistry, Malabar Cancer Centre, Kannur, Kerala, India. 6. Professor, Department of Biochemistry, Amala Institute of Medical Sciences, Thrissur, Kerala, India.
 
Correspondence Address :
Edakkadath Raghavan Sindhu, Emilin Zacharias, Keezhpally Soman Mini, Therayangalath Bindu, Padippurayil Faizal, Thekkoottuparambil Ananthanarayanan Ajith,
Dr. Edakkadath Raghavan Sindhu,
Assistant Professor, Division of Biochemistry Malabar Cancer Centre, Kodiyeri, Moozhikkara (P.O.), Thalassery, Kannur Dist., Kannur, Kerala-670103, India.
E-mail: sindhuermcc@gmail.com
 
ABSTRACT
: Introduction: Maintaining the reliability of clinical laboratory results is essential for accurate diagnosis and monitoring treatment outcomes. Due to poor awareness regarding the statistical evaluation of Internal Quality Control (IQC) results from two analysers, most laboratories in tertiary care centres do not conduct comparative studies, which may lead to erroneous results.
Aim: To compare the performance of two analysers Vitros 5600 and Vitros 250 (which utilise the same techniques and methods of estimation), within the same clinical chemistry laboratory, rather than relying solely on daily monitoring of each analyser. Additionally, it emphasises the importance of periodic statistical analysis of Bio-Rad Independent Quality Control (IQC) samples.
Materials and Methods: An analytical cross-sectional study was conducted at the Division of Biochemistry, Malabar Cancer Centre, Kannur, Kerala, India from July 2022 to October 2022. Two levels of IQC samples were run daily on the Vitros 5600 (reference equipment) and Vitros 250 (test equipment), both of which are integrated dry chemistry fully automated analyser using the same batch of reagents. After each run, the acceptability of the control values was verified against the laboratory control limits according to Westgard multiple rules. If results from an analyser fell outside the acceptable range, the analyser was calibrated and the IQC procedure was performed again. Acceptable values were recorded for comparison.
Results: The superiority of the reference analyser in terms of analytical performance was evidenced by consistently lower Coefficient of Variation (CV%) values across multiple analytes. However, a negative correlation was observed for phosphorus at level two in Analyser 2, indicating potential systematic bias in measurements for this specific analyte. Phosphorus at Level 1 showed a correlation coefficient of 0.576 (p-value=0.008), while phosphorus at Level 2 had a correlation coefficient of -0.758 (p-value <0.0001). Bland-Altman analysis indicated minimal mean differences between the analysers.
Conclusion: The Vitros 5600 (reference equipment) performed well, with minimal deviations in results, underscoring its potential for accurate clinical testing. The present study highlights the importance of periodic statistical analysis to compare the performance of two analysers in a clinical chemistry laboratory, rather than relying solely on daily quality checks.
Keywords : Accuracy, Analytical chemistry technique, Clinical laboratory services, Precision, Quality control
DOI and Others : DOI: 10.7860/NJLM/2025/67956.2890 Date of Submission: Oct 09, 2023 Date of Peer Review: Jan 08, 2024 Date of Acceptance: Sep 12, 2024 Date of Publishing: Jan 01, 2025 AUTHOR DECLARATION: • Financial or Other Competing Interests: None • Was Ethics Committee Approval obtained for this study? No • Was informed consent obtained from the subjects involved in the study? No • For any images presented appropriate consent has been obtained from the subjects. NA PLAGIARISM CHECKING METHODS
 
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