A survey of the reactivity of <i>in vitro</i> diagnostic bilirubin reagents developed in Japan using artificially prepared bilirubin materials: A comparison of synthetic delta, unconjugated, and taurine-conjugated bilirubin

Kiuchi, Sachiko; Ihara, Hiroshi; Osawa, Satoshi; Ishibashi, Midori; Kinpara, Kiyoko; Ohtake, Kazuko; Ida, Takehisa; Miura, Yoshinori; Fujimura, Yuko; Ueda, Shigeru; Hirano, Yuya; Watahiki, Kensuke; Takada, Daiichiro; Shinzaki, Akihiro; Tanimoto, Keishi; Adachi, Hiroshi; Nejime, Tetsuya; Totani, Masayuki; Itoh, Shinji

doi:10.1177/00045632211026699

Cited by 2 publications

(1 citation statement)

References 22 publications

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“…However, few studies have compared these two methods using a large number of samples. A recent study using artificially prepared bilirubin materials from the Japan Society of Clinical Chemistry reported no difference between the two methods, 22 which is consistent with the results of the present study. These results suggest that differences in measurement methods may not affect ALBI grade, at least in cases with low T-BIL concentrations as in this study.…”

Section: Discussionsupporting

confidence: 92%

Effect of albumin measurement methods on the albumin–bilirubin grade

Tanaka¹,

Tanaka²,

Suzuki³

et al. 2022

Ann Clin Biochem

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Background: Albumin-bilirubin (ALBI) grade is an index of liver function based on total bilirubin (T-BIL) and albumin levels, and its usefulness has been widely reported. This study aimed to investigate the effect of different methods of measuring T-BIL and albumin levels on the ALBI grade in patients with liver disease. Methods: In total, 170 patients from our hospital were included in this study. Correlations between T-BIL levels measured using the vanadate oxidation and enzymatic methods were analyzed. Similarly, a correlation analysis of albumin levels between the bromocresol green (BCG) and modified bromocresol purple (BCP) methods was performed. Additionally, the ALBI grade was calculated for patients with liver disease, and the differences between each method of albumin measurement were compared. Results: No differences were observed in the measured T-BIL values between the two methods. Contrastingly, the albumin levels of 100 random samples and 70 liver disease patients obtained using the modified BCP method were significantly lower than those measured using the BCG method. The rate of change in the modified ALBI grade between the BCG and BCP methods was 25.7%. Conclusions: Caution should be taken when comparing ALBI grades with those measured by other facilities because the method of albumin measurement can affect the ALBI grade. Standardization of albumin measurement is needed worldwide.

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Section: Discussionsupporting

confidence: 92%

Effect of albumin measurement methods on the albumin–bilirubin grade

Tanaka¹,

Tanaka²,

Suzuki³

et al. 2022

Ann Clin Biochem

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Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization

Hulzebos,

Camara,

van Berkel

et al. 2024

Clinical Chemistry and Laboratory Medicine (CCLM)

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Measurement of total bilirubin (TBil) concentration in serum is the gold standard approach for diagnosing neonatal unconjugated hyperbilirubinemia. It is of utmost importance that the measured TBil concentration is sufficiently accurate to prevent under treatment, unnecessary escalation of care, or overtreatment. However, it is widely recognized that TBil measurements urgently require improvement in neonatal clinical chemistry. External quality assessment (EQA) programs for TBil assess for differences between laboratories and provide supporting evidence of significant differences between various methods, manufacturers and measurement platforms. At the same time, many countries have adopted or only slightly adapted the neonatal hyperbilirubinemia management guidelines from the USA or UK, often without addressing differences in the methodology of TBil measurements. In this report, we provide an overview of the components of bilirubin that are measured by laboratory platforms, the availability of current reference measurement procedures and reference materials, and the role of EQA surveys in this context. Furthermore, the current status of agreement in neonatal bilirubin against clinical decision thresholds is reviewed. We advocate for enhancements in accuracy and comparability of neonatal TBil measurements, propose a path forward to accomplish this, and reflect on the position of the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Working Group Neonatal Bilirubin (WG-NB) in this matter.

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A survey of the reactivity of in vitro diagnostic bilirubin reagents developed in Japan using artificially prepared bilirubin materials: A comparison of synthetic delta, unconjugated, and taurine-conjugated bilirubin

Cited by 2 publications

References 22 publications

Effect of albumin measurement methods on the albumin–bilirubin grade

Effect of albumin measurement methods on the albumin–bilirubin grade

Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization

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