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<p>Mutual recognition of bilirubin measurement results across clinical laboratories is critical for harmonization, accreditation, evidence-based laboratory medicine, and the minimization of redundant patient testing. Here, we assessed the comparability of bilirubin measurements across clinical laboratories in Sichuan and Chongqing (Southwest China) to inform regional initiatives for mutual recognition of such results. Five fresh pooled serum samples with varying bilirubin concentrations were distributed to 18 clinical laboratories. Participants measured total bilirubin (TBIL) and direct bilirubin (DBIL) using their routine analytical protocols; indirect bilirubin (IBIL) and DBIL/TBIL ratio were derived from these measurements. Data were analyzed using robust statistical metrics: median, interquartile range, normalized IQR, robust coefficient of variation, and percentage difference (PD) relative to the median. Using the median as the target value, we assessed pass rates for TBIL, DBIL, IBIL, and DBIL/TBIL ratio against acceptability criteria derived from biological variation. The laboratory with the lowest average absolute percentage difference (APD) for TBIL was designated as the reference testing system; we then assessed the consistency of bilirubin measurements between the remaining 17 laboratories and this reference system. When using the appropriate total allowable error (TEa) derived from biological variation (± 24.7 %) as the acceptability threshold for analyte PDs, pass rates were 100.0 % for TBIL, 44.4–100.0 % for DBIL, 44.4–88.9 % for IBIL, and 55.6–72.2 % for DBIL/TBIL ratio. In contrast, using the optimal TEa (± 12.3 %) as the threshold, pass rates dropped to 72.2–94.4 % (TBIL), 33.3–61.1 % (DBIL), 11.1–33.3 % (IBIL), and 44.4–50.0 % (DBIL/TBIL ratio). Relative to the reference measuring system (an end-user’s routine procedure in this study), six laboratories (35.3 %) had inconsistent TBIL measurements, whereas 12 laboratories (70.6 %) showed inconsistencies in DBIL, IBIL, and DBIL/TBIL ratio results. Clinical laboratories in the Sichuan–Chongqing region exhibit substantial differences in bilirubin measurement results across. Achieving standardization and mutual recognition of these results will require three key steps: standardization of analytical methods, traceability to reference materials or procedures, and conduct comparison activities using commutable materials.</p>

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Differences in bilirubin measurement results across clinical laboratories

  • 期刊论文

  • 发表日期：

    2026年4月15日

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  • Guangjun Xiao,
  • Yanting Liu,
  • Juan Hu,
  • Yutao Wang,
  • Huanhuan Wang,
  • Shaocheng Zhang

摘要

Mutual recognition of bilirubin measurement results across clinical laboratories is critical for harmonization, accreditation, evidence-based laboratory medicine, and the minimization of redundant patient testing. Here, we assessed the comparability of bilirubin measurements across clinical laboratories in Sichuan and Chongqing (Southwest China) to inform regional initiatives for mutual recognition of such results. Five fresh pooled serum samples with varying bilirubin concentrations were distributed to 18 clinical laboratories. Participants measured total bilirubin (TBIL) and direct bilirubin (DBIL) using their routine analytical protocols; indirect bilirubin (IBIL) and DBIL/TBIL ratio were derived from these measurements. Data were analyzed using robust statistical metrics: median, interquartile range, normalized IQR, robust coefficient of variation, and percentage difference (PD) relative to the median. Using the median as the target value, we assessed pass rates for TBIL, DBIL, IBIL, and DBIL/TBIL ratio against acceptability criteria derived from biological variation. The laboratory with the lowest average absolute percentage difference (APD) for TBIL was designated as the reference testing system; we then assessed the consistency of bilirubin measurements between the remaining 17 laboratories and this reference system. When using the appropriate total allowable error (TEa) derived from biological variation (± 24.7 %) as the acceptability threshold for analyte PDs, pass rates were 100.0 % for TBIL, 44.4–100.0 % for DBIL, 44.4–88.9 % for IBIL, and 55.6–72.2 % for DBIL/TBIL ratio. In contrast, using the optimal TEa (± 12.3 %) as the threshold, pass rates dropped to 72.2–94.4 % (TBIL), 33.3–61.1 % (DBIL), 11.1–33.3 % (IBIL), and 44.4–50.0 % (DBIL/TBIL ratio). Relative to the reference measuring system (an end-user’s routine procedure in this study), six laboratories (35.3 %) had inconsistent TBIL measurements, whereas 12 laboratories (70.6 %) showed inconsistencies in DBIL, IBIL, and DBIL/TBIL ratio results. Clinical laboratories in the Sichuan–Chongqing region exhibit substantial differences in bilirubin measurement results across. Achieving standardization and mutual recognition of these results will require three key steps: standardization of analytical methods, traceability to reference materials or procedures, and conduct comparison activities using commutable materials.