Division of Research, Kaiser Permanente Northern California, Oakland2Division of Neonatology, Kaiser Permanente Northern California, Oakland, California3Department of Pediatrics, University of California, San Francisco.
Department of Laboratory Medicine, University of Washington, Seattle.
JAMA Pediatr. 2016 Jun 1;170(6):557-61. doi: 10.1001/jamapediatrics.2015.4944.
The American Academy of Pediatrics 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.
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 (January 1, 2010, through April 30, 2012; n = 61 677) and after (July 1, 2012, through December 31, 2013; n = 42 571) recalibration. The analysis took place in December 2015.
Recalibration of bilirubin testing instruments.
Proportions of newborns with (1) at least 1 TSB value at or above 15 mg/dL; (2) at least 1 TSB level exceeding the American Academy of Pediatrics phototherapy threshold; (3) phototherapy during the birth hospitalization; and (4) at least 1 readmission for phototherapy.
In 104 420 infants (61 677 in the prerecalibration period and 42 511 in the postrecalibration period), a TSB was obtained in 99.2% of infants during birth and in 99.5% of infants within the first 30 days after birth. The postrecalibration period was associated with a 1.25 mg/dL (95% CI, 1.19-1.31; P < .001) decrease in mean maximum TSB, which led to a 39% relative reduction (from 20.4% to 12.4%) in infants with a TSB level of 15 mg/dL or more and a 51% relative reduction (from 9.3% to 4.5%) in infants with a TSB level that was at or above the American Academy of Pediatrics phototherapy threshold. Phototherapy during birth hospitalizations was reduced by 59% (absolute risk reduction, 5.5%; 95% CI, 4.7%-6.1%) and readmissions for phototherapy by 53% (absolute risk reduction, 1.8%; 95% CI, 1.4%-2.3%).
Modest recalibration-induced reductions in mean TSB concentrations was associated with a significant reduction in the percentage of infants with clinically significant hyperbilirubinemia. Current laboratory accuracy standards are insufficient to detect biases that can have significant clinical effect. These data underline the need for increased integration of laboratory expertise into clinical guidelines and to support international initiatives to standardize laboratory measurements.
美国儿科学会对新生儿黄疸的治疗建议是基于特定年龄的总血清胆红素（TSB）水平。2012 年 5 月，由于对 Ortho Clinical Diagnostics 的 Vitros Chemistry Products BuBc Slides（Ortho Clinical Diagnostics）检测 TSB 的校准值存在正偏结果的担忧，该公司对其进行了调整。
研究一种反射分光光度法血清胆红素检测方法的重新校准与新生儿 TSB 水平和光疗使用之间的关系。
设计、地点和参与者：描述性研究，比较 Kaiser Permanente Northern California 大型综合医疗保健系统在重新校准前后 TSB 水平和光疗使用情况。该研究评估了在 12 个设施中，胎龄 35 周或以上的活产儿，这些设施在重新校准前（2010 年 1 月 1 日至 2012 年 4 月 30 日；n=61677）和重新校准后（2012 年 7 月 1 日至 2013 年 12 月 31 日；n=42571）均使用了普遍的血清胆红素筛查。分析于 2015 年 12 月进行。
胆红素检测仪器的重新校准。
（1）至少有 1 次 TSB 值为 15mg/dL 或以上的新生儿比例；（2）至少有 1 次 TSB 水平超过美国儿科学会光疗阈值的新生儿比例；（3）在出生住院期间接受光疗的新生儿比例；（4）至少有 1 次因光疗而再次住院的新生儿比例。
在 104420 名婴儿中（重新校准前有 61677 名，重新校准后有 42511 名），出生时 99.2%的婴儿和出生后 30 天内的 99.5%的婴儿获得了 TSB 值。重新校准后，平均最大 TSB 值下降了 1.25mg/dL（95%CI，1.19-1.31；P<0.001），导致 TSB 值为 15mg/dL 或更高的婴儿比例相对减少了 39%（从 20.4%降至 12.4%），TSB 值达到或超过美国儿科学会光疗阈值的婴儿比例相对减少了 51%（从 9.3%降至 4.5%）。在出生住院期间接受光疗的比例降低了 59%（绝对风险降低 5.5%；95%CI，4.7%-6.1%），因光疗再次住院的比例降低了 53%（绝对风险降低 1.8%；95%CI，1.4%-2.3%）。
适度的重新校准引起的 TSB 浓度降低与具有显著临床意义的高胆红素血症婴儿比例显著降低有关。目前的实验室精度标准不足以检测到可能具有显著临床影响的偏差。这些数据强调了将实验室专业知识纳入临床指南的必要性，并支持制定国际倡议来规范实验室测量。
