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  4. Vol 3, Issue 1, 2025

Performance Verification of Beckman Coulter AU5821 Automatic Biochemistry Analyzer

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DOI: 10.23977/medbm.2025.030104 | Downloads: 7 | Views: 160

Author(s)

Zhao Peng 1,2, Farra Aidah Jumuddin 1

Affiliation(s)

1 Faculty of Medicine, Lincoln University College, Jalan SS 6/12, 47301 Petaling Jaya, Selangor, Malaysia
2 Department of Clinical Laboratory, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Corresponding Author

Farra Aidah Jumuddin

ABSTRACT

In order to ensure the accuracy of laboratory test results, performance verification of the Beckman Coulter Model AU5821 Automated Biochemistry Analyser was carried out to validate the reliability of the manufacturer's stated performance specifications for the test system. With reference to CNAS-GL037:2019 'Guidelines for Performance Validation of Quantitative Clinical Chemistry Test Procedures' and WS/T 407-2012, the BECKMAN COULTER AU5821 Automatic Biochemistry Analyser was used to perform routine tests on potassium, sodium, chloride, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatine kinase, urea nitrogen, creatinine, uric acid, glucose, triglycerides, cholesterol, HDL, LDL, calcium, glucose, triglycerides, cholesterol, LDL, calcium, glucose, glutaminase, glutaminyl kinase and glutaminase. Alkaline Phosphatase, Glutamyl Aminotransferase, Creatine Kinase, Urea Nitrogen, Creatinine, Uric Acid, Glucose, Triglyceride, Cholesterol, HDL, LDL, Calcium, Phosphorus, Magnesium, etc. The correctness, precision, reportable interval, linear range, reference range of the 22 items are measured. The precision and correctness of the 22 routine biochemical test items determined by the testing system are in line with the judgement standards of the document WS/T407 2012; the linear ranges, reportable ranges, reference ranges, and statements of the routine test items are consistent with those of the manufacturer. The BECKMAN COULTER AU5821 fully automated biochemistry analyser testing system meets the performance targets for quality objectives and can perform routine clinical sample testing.

KEYWORDS

Performance Validation, Correctness, Precision, Reportable Intervals, Linear Ranges, Reference Ranges

CITE THIS PAPER

Zhao Peng, Farra Aidah Jumuddin, Performance Verification of Beckman Coulter AU5821 Automatic Biochemistry Analyzer. MEDS Basic Medicine (2025) Vol. 3: 17-25. DOI: http://dx.doi.org/10.23977/medbm.2025.030104.

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