Direct Spectrophotometric Method for Measurement of Bilirubin in Newborns: Comparison with HPLC and an Automated Diazo Method

Kazmierczak, Steven C.; Robertson, Alex; Catrou, Paul G.; Briley, Kimberly P.; Kreamer, Bill L.; Gourley, Glenn R.

doi:10.1093/clinchem/48.7.1096

Cited by 67 publications

(31 citation statements)

References 9 publications

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“…In most clinical settings TSB is determined rather by the Diazo (Jendrassik-Gróf-based) reaction method or direct spectrophotometry. 84,85 The use of TcB as proxy or pre-screening tool for TSB to reduce the rate of unnecessary and painful blood draws in newborns is not uncommon. 14,25,33 TcB devices are non-invasive and convert the colour of the baby's skin into a bilirubin value using specific algorithms.…”

Section: Early Detection and Diagnosismentioning

confidence: 99%

Neonatal hyperbilirubinaemia: a global perspective

Olusanya

Kaplan

Hansen

2018

The Lancet Child & Adolescent Health

216

195

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Hyperbilirubinaemia, presenting as jaundice, is a ubiquitous and frequently benign condition in newborn babies but is a leading cause of hospitalisation in the first week of life. In some infants jaundice can become severe, progressing to acute bilirubin encephalopathy and kernicterus with a substantial risk of neonatal mortality and long-term neurodevelopmental impairments. Severe hyperbilirubinaemia and its sequelae continue to occur in industrialised countries with functioning medical systems and a disproportionately high burden also persists in low-income and middle-income countries due primarily to delays in delivering effective treatments that are routinely available in high-income countries. In this Review we summarise up-to-date evidence on the epidemiology of neonatal jaundice including its global burden based on estimates of its prevalence, and both fatal and non-fatal health outcomes. We also discuss the management of severe hyperbilirubinaemia including the prevention of kernicterus, and highlight future directions for research.

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Section: Early Detection and Diagnosismentioning

confidence: 99%

Neonatal hyperbilirubinaemia: a global perspective

Olusanya

Kaplan

Hansen

2018

The Lancet Child & Adolescent Health

216

195

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“…[6][7][8] The Vitros BuBc Neonatal Bilirubin assay (Ortho Clinical Diagnostics) is one of only a few commercially available reflectance spectrophotometry assays for measuring serum bilirubin in the clinical laboratory. 9,10 The instrument provides 2 measured and 1 calculated result per sample: unconjugated bilirubin, conjugated bilirubin, and the sum of the 1 (unconjugated bilirubin + conjugated bilirubin = TSB). On May 21, 2012, Ortho Clinical Diagnostics notified customers that it had "received customer complaints of positively biased results using Vitros … BuBc Slides for CAP [College of American Pathologists] proficiency testing."…”

mentioning

confidence: 99%

Association Between Laboratory Calibration of a Serum Bilirubin Assay, Neonatal Bilirubin Levels, and Phototherapy Use

et al. 2016

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treatment recommendations for neonatal jaundice are based on age-specific total serum bilirubin (TSB) levels. In May 2012, Ortho Clinical Diagnostics adjusted the calibrator values for Vitros Chemistry Products BuBc Slides (Ortho Clinical Diagnostics), a widely used method to quantify TSB, after concerns of positively biased results. OBJECTIVE To investigate the association between recalibration of a reflectance spectrophotometry serum bilirubin assay and TSB levels and phototherapy use among newborns. DESIGN, SETTING, AND PARTICIPANTS Descriptive study comparing TSB levels and phototherapy use before and after recalibration at Kaiser Permanente Northern California, a large, integrated health care delivery system. The study evaluated live births at or after 35 weeks' gestation at 12 facilities that used universal serum bilirubin screening before (

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“…This technical evaluation had some limitations: the BS was not compared to the gold standard measurement of serum bilirubin by HPLC 36 or with the Cobas c111 machine which would have required a larger volume of blood with venous sampling and analysis at the central laboratory in Mae Sot (30 km away). Moreover, due to the limited number of strips available, the high rates of errors, and the use of two different BS readers, the number of samples analysed in similar environmental conditions was small.…”

Section: Discussionmentioning

confidence: 99%

Laboratory validation and field usability assessment of a point-of-care test for serum bilirubin levels in neonates in a tropical setting

Thielemans¹,

Hashmi²,

Priscilla³

et al. 2018

Wellcome Open Res

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Background: Screening and monitoring serum bilirubin (SBR) in neonates is crucial to prevent neonatal hyperbilirubinemia (NH)-associated morbidity and mortality worldwide. A lack of resources is often a barrier for measuring SBR in developing countries. Reliable, cost-effective, easy to use point-of-care (POC) SBR tests are needed. This study aimed to evaluate the technical accuracy and usability of the Bilistick System (BS), a new bilirubin POC test, in a tropical setting. Methods: This was a mixed-methods study, including laboratory validation of the BS, direct observation of technical procedures as performed by the midwives and midwives’ assessment of the device’s easiness of use through focus group discussions (FGD) and a self-administered questionnaire. The study was conducted in a field clinic of the Shoklo Malaria Research Unit along the Thailand-Myanmar border between January and December 2017. Results: A total of 173 samples were tested at a median age of 4 days. BS generated an error message—providing no SBR readout—in 48.6% of the tests performed. For the tests that yielded a result, the correlation coefficient (95% CI) between BS and routine laboratory bilirubinometer SBR was 0.87 (0.77-0.93). The accuracy decreased with increasing haematocrit and at higher humidity (≥75%). Direct observation of the operators using the device and analysis of the focus group discussions and questionnaires indicated that the BS was considered easy to use and required limited training. Conclusions: This evaluation showed that the BS, in its current formulation, does not provide reliable results for measuring SBR in a tropical, low-resource setting but has acceptable usability features.

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Direct Spectrophotometric Method for Measurement of Bilirubin in Newborns: Comparison with HPLC and an Automated Diazo Method

Cited by 67 publications

References 9 publications

Neonatal hyperbilirubinaemia: a global perspective

Neonatal hyperbilirubinaemia: a global perspective

Association Between Laboratory Calibration of a Serum Bilirubin Assay, Neonatal Bilirubin Levels, and Phototherapy Use

Laboratory validation and field usability assessment of a point-of-care test for serum bilirubin levels in neonates in a tropical setting

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