INTRODUCTION It is unclear if serum procalcitonin (PCT) estimated at sepsis suspicion can help detect culture-positive sepsis in neonates. We evaluated the diagnostic performance of PCT in culture-positive sepsis in neonates. METHODS This was a prospective study (February 2016 to September 2020) conducted in four level-3 units in India. We enrolled neonates suspected of sepsis in the first 28 days of life. Neonates with birth weight <750 g, asphyxia, shock, and major malformations were excluded. Blood for PCT assay was drawn along with the blood culture at the time of suspicion of sepsis and before antibiotic initiation. The investigators labeled the neonates as having culture-positive sepsis or "no sepsis" based on the culture reports and clinical course. PCT assay was performed by electrochemiluminescence immunoassay, and the clinicians were masked to the PCT levels while assigning the label of sepsis. Primary outcomes were the sensitivity, specificity, and likelihood ratios to identify culture-positive sepsis. RESULTS The mean birth weight (SD) and median gestation (IQR) were 2,113 (727) g and 36 (32-38) weeks, respectively. Of the 1,204 neonates with eligible cultures, 155 (12.9%) had culture-positive sepsis. Most (79.4%) were culture-positive within 72 h of birth. The sensitivity, specificity, and positive and negative likelihood ratios at 2 ng/mL PCT threshold were 52.3% (95% confidence interval: 44.1-60.3), 64.5% (60.7-68.1), 1.47 (1.23-1.76), and 0.74 (0.62-0.88), respectively. Adding PCT to assessing neonates with 12.9% pretest probability of sepsis generated posttest probabilities of 18% and 10% for positive and negative test results, respectively. CONCLUSION Serum PCT did not reliably identify culture-positive sepsis in neonates.

中文翻译：

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降钙素原用于检测新生儿培养阳性败血症：一项前瞻性、多中心研究。

引言 目前尚不清楚在怀疑脓毒症时评估血清降钙素原 (PCT) 是否有助于检测新生儿培养阳性脓毒症。我们评估了 PCT 对新生儿培养阳性脓毒症的诊断性能。方法 这是一项在印度四个 3 级单位进行的前瞻性研究（2016 年 2 月至 2020 年 9 月）。我们招募了出生后 28 天内疑似败血症的新生儿。排除出生体重<750 g、窒息、休克、重大畸形的新生儿。在怀疑脓毒症时和开始使用抗生素之前，抽取用于 PCT 测定的血液以及血培养物。研究人员根据培养报告和临床病程将新生儿标记为培养阳性败血症或“无败血症”。PCT检测采用电化学发光免疫分析法进行，临床医生在分配脓毒症标签时不知道PCT水平。主要结果是识别培养阳性脓毒症的敏感性、特异性和似然比。结果 平均出生体重 (SD) 和中位妊娠 (IQR) 分别为 2,113 (727) g 和 36 (32-38) 周。在 1,204 名符合培养条件的新生儿中，155 名（12.9%）患有培养阳性败血症。大多数（79.4%）在出生后 72 小时内培养呈阳性。2 ng/mL PCT 阈值时的敏感性、特异性以及阳性和阴性似然比分别为 52.3%（95% 置信区间：44.1-60.3）、64.5%（60.7-68.1）、1.47（1.23-1.76）和 0.74（ 0.62-0.88），分别。将 PCT 添加到评估脓毒症预测试概率为 12.9% 的新生儿中，测试后的阳性和阴性结果概率分别为 18% 和 10%。结论 血清 PCT 不能可靠地识别新生儿培养阳性脓毒症。