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Accreditation and Quality Assurance

, Volume 23, Issue 2, pp 97–102 | Cite as

Trueness verification survey for blood lead concentration measurement in Chinese clinical laboratories

  • Shuai Yuan
  • Wei Wang
  • Jianping Li
  • Mingxia Liu
  • Junwei Xin
  • Fa L. He
  • Kun Zhong
  • Zhi G. Wang
Practitioner's Report
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Abstract

The results of trueness verification for blood lead measurement were analyzed in a 2016 nationwide external quality assessment (EQA) survey, in order to evaluate current approaches of blood lead measurement in Chinese Laboratories and their traceability to certified reference materials (CRMs). A panel of 2 frozen whole blood CRMs with values assigned by an absolute quantitative method was provided to 12 laboratories with satisfactory performances from the 2015 blood lead EQA scheme. Participants were required to measure the samples 5 times each day for 3 consecutive days and report all 15 data, which were then calculated for means and standard deviations. Data were statistically analyzed by adopted method groups, before comparing with the assigned values to assess the trueness of blood lead measurement using different approaches. Eleven laboratories reported on schedule, rendering a reporting rate of 91.7 %. The target values for the two batches were (37.6 ± 2.7) μg/L and (124.6 ± 4.5) μg/L, respectively. By the evaluation criterion of target value ± 20 µg/L, the pass rates were 72.7 % for the lower concentration and 54.5 % for the higher concentration, while 5 out of 11 laboratories delivered satisfactory results for both CRMs. The overall performance of the few participating laboratories in this EQA survey was basically acceptable by CLSI standard on the whole, yet barely desirable for the higher concentration. Therefore, trueness verification of blood lead measurement with CRMs is potentially necessary for national EQA schemes, which can be imperative as part of the validation procedures of analytical methods in clinical settings.

Keywords

Blood lead Trueness verification Certified reference material Traceability 

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  • Shuai Yuan
    • 1
  • Wei Wang
    • 1
  • Jianping Li
    • 2
  • Mingxia Liu
    • 3
  • Junwei Xin
    • 4
  • Fa L. He
    • 1
  • Kun Zhong
    • 1
  • Zhi G. Wang
    • 1
  1. 1.National Center for Clinical LaboratoriesBeijing HospitalBeijingChina
  2. 2.Xi’an Central HospitalShanxiChina
  3. 3.Suzhou Bacme Biotech Co., LtdJiangsuChina
  4. 4.Wuxi Shenrui Biopharmaceutical Co., LtdJiangsuChina

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