2013Laboratory Medicine and ClinicRequires access

Performance evaluation of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol

Xue Yun-song

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Abstract

Objective To evaluate the performance feature of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol(HDL-C).Methods Referring to the evaluation protocol documents and literature and combining our actual work,the precision,accuracy,analytical measurement range,and biotic interval of HDL-C were validated.Results The within-run and day precision were all consistent with the claim of manufacturer.The biases of mean and target value that detected in five quality control specimens were in the range of permission.Analytical measurement range was 0-5.21 mmol/L,that wider than the manufacture's claim slightly.The biological reference range was within the setting range.Different concentrations of free bilirubin,direct bilirubin,chylomicrons,and hemoglobin had no influence on HDL-C detection.Conclusion The main analytical performances of serum total bile acid by automatic biochemical analyzer were consistent with the claim defined by manufacturer,and could be satisfied with the clinical detection.

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What this paper is about

Objective To evaluate the performance feature of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol(HDL-C).Methods Referring to the evaluation protocol documents and literature and combining our actual work,the precision,accuracy,analytical measurement range,and biotic interval of HDL-C were validated.Results The within-run and day precision were all consistent with the claim of manufacturer.The biases of mean and target value that detected in five quality control specimens were in the range of permission.Analytical measurement range was 0-5.21 mmol/L,that wider than the manufacture's claim slightly.The biological reference range was within the setting range.Different concentrations of free bilirubin,direct bilirubin,chylomicrons,and hemoglobin had no influence on HDL-C detection.Conclusion The main analytical performances of serum total bile acid by automatic biochemical analyzer were consistent with the claim defined by manufacturer,and could be satisfied with the clinical detection.

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Available abstract

Objective To evaluate the performance feature of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol(HDL-C).Methods Referring to the evaluation protocol documents and literature and combining our actual work,the precision,accuracy,analytical measurement range,and biotic interval of HDL-C were validated.Results The within-run and day precision were all consistent with the claim of manufacturer.The biases of mean and target value that detected in five quality control specimens were in the range of permission.Analytical measurement range was 0-5.21 mmol/L,that wider than the manufacture's claim slightly.The biological reference range was within the setting range.Different concentrations of free bilirubin,direct bilirubin,chylomicrons,and hemoglobin had no influence on HDL-C detection.Conclusion The main analytical performances of serum total bile acid by automatic biochemical analyzer were consistent with the claim defined by manufacturer,and could be satisfied with the clinical detection.

Key concepts: Spectrum analyzer, Cholesterol, Reference range, Bilirubin, High-density lipoprotein, Range (aeronautics), Protocol (science), Computer science

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