Evaluation of Analysis Performance of Automatic Biochemical Analyzer in Detecting Serum Lipoprotein A

Yun-song XUE; Li-li LI; Qian FENG; Yi-zheng LI; Lin-hua ZHOU; Jin-yi GU; Jian-mei LIU

doi:10.12259/j.issn.2095-610X.S20210312

Volume 42 Issue 3

Apr. 2021

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Article Navigation > Journal of Kunming Medical University > 2021 > 42(3): 49-53

Yun-song XUE, Li-li LI, Qian FENG, Yi-zheng LI, Lin-hua ZHOU, Jin-yi GU, Jian-mei LIU. Evaluation of Analysis Performance of Automatic Biochemical Analyzer in Detecting Serum Lipoprotein A[J]. Journal of Kunming Medical University, 2021, 42(3): 49-53. doi: 10.12259/j.issn.2095-610X.S20210312

Citation:

Yun-song XUE, Li-li LI, Qian FENG, Yi-zheng LI, Lin-hua ZHOU, Jin-yi GU, Jian-mei LIU. Evaluation of Analysis Performance of Automatic Biochemical Analyzer in Detecting Serum Lipoprotein A[J]. Journal of Kunming Medical University, 2021, 42(3): 49-53. doi: 10.12259/j.issn.2095-610X.S20210312

Citation:

Yun-song XUE, Li-li LI, Qian FENG, Yi-zheng LI, Lin-hua ZHOU, Jin-yi GU, Jian-mei LIU. Evaluation of Analysis Performance of Automatic Biochemical Analyzer in Detecting Serum Lipoprotein A[J]. Journal of Kunming Medical University, 2021, 42(3): 49-53. doi: 10.12259/j.issn.2095-610X.S20210312

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Evaluation of Analysis Performance of Automatic Biochemical Analyzer in Detecting Serum Lipoprotein A

doi: 10.12259/j.issn.2095-610X.S20210312

Dept. of Laboratory Medicine，The Second People’s Hospital of Yunnan Province，Kunming Yunnan 650021，China

Received Date: 2020-12-28
Publish Date: 2021-04-09

Abstract

Abstract

Objective To evaluate the assay performance of automatic biochemical analyzer in detecting serum lipoprotein A [LP（a）] by using latex agglutination-turbidimetry on a（Abbott C16000）, so as to evaluate whether it can meet clinical requirements. Methods According to international and domestic performance evaluation documents and industry standards, the evaluation was carried out from the aspects of precision, accuracy a, analytical measurement range, clinical reportable range, anti-interference performance and biological reference range. Results The intra-batch imprecisions of LP（a）were 1.44%, 0.45% and 0.91% at quality control level 1, 2 and mixed serum samples, and the inter-batch imprecisions were 1.67%, 0.81% and 1.23%, respectively, which were lower than the standard declared by the manufacturer. The correlation coefficient R2 was 0.9990 when comparing the samples with the same testing system approved by ISO15189 laboratory. The analytical measurement range was 11.0-919.0 mg/L. The maximum allowable dilution was 10 times, and the maximum reportable range was extended to 9190.0 mg/L. Commercial interference substance detection results showed that the deviation of free bilirubin was less than 20 mg/dL, binding bilirubin was less than 20 mg/dL, chylous turbidity was less than 3 000 FTU, hemoglobin was less than 500 mg/dL on the detection result of LP（a）was less than 10%, indicating that these concentrations of substances had little interference on the detection result of LP（a）. The reference interval cited by the laboratory was verified by 40 healthy population samples. Conclusion The analytical performance of automatic biochemical analyzer in detecting LP（A）is basically consistent with the manufacturer's statement, which can meet the clinical requirements and can be applied in clinical practice.
- Lipoprotein A,
- Automatic biochemical analyzer,
- Performance evaluation

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