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Evaluation of a point-of-care direct spectrophotometric method for measurement of total serum bilirubin in term and near-term neonates

Abstract

Objective:

To evaluate point-of-care (POC) measurement of total serum bilirubin (TSB) in the management of neonatal jaundice.

Study design:

TSB was measured by a POC direct spectrophotometric bilirubin method (Unistat™ (U/TSB)) and a standard diazo clinical laboratory method (Olympus AU640E analyzer (diazo/TSB)). Agreement between U/TSB and diazo/TSB was assessed by correlation coefficient and Bland–Altman analysis. Transcutaneous bilirubin (TcB) was measured using JM-103™ (JM).

Results:

Correlation between U/TSB and diazo/TSB was 0.99 (n=120). Maximum difference (U/TSB minus diazo/TSB) was −2.9 mg/dl, and 79% were ±1 mg/dl; the average difference was −0.37±0.70 mg/dl and the average absolute difference was 0.60±0.52 mg/dl. Median time to determine U/TSB was 5 min. Correlation between U/TSB and JM was 0.92 (n=113). Maximum difference (U/TSB minus JM) was 6.3 mg/dl, and 45% were ±1 mg/dl; the average difference was 0.7±1.8 mg/dl and the average absolute difference was 1.4±1.2 mg/dl.

Conclusion:

Measurement of TSB using Unistat™ provides excellent agreement with diazo/TSB and rapid turnaround time. This technique may provide reliable POC confirmation of TcB results that are above a screening cutoff value.

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Acknowledgements

We appreciate the participation of the Parkland Health and Hospital System's Clinical Pathology Laboratory for providing financial assistance for total serum bilirubin levels, Reichert, Inc., for providing the Unistat™, centrifuge, and pipette at no charge, and Minolta/Hill-Rom Air-Shields who provided the JM-103™ at no charge.

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Correspondence to G L Jackson.

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Barko, H., Jackson, G. & Engle, W. Evaluation of a point-of-care direct spectrophotometric method for measurement of total serum bilirubin in term and near-term neonates. J Perinatol 26, 100–105 (2006). https://doi.org/10.1038/sj.jp.7211436

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