Bithi Nazmin, Ibrahim Ridwan B, Tam Estella L, Almamoun Radwa, Frenk Oquendo Annette C, Akcan-Arikan Ayse, Devaraj Sridevi
Department of Pathology and Immunology, Baylor College of Medicine, Houston, TX, USA.
Department of Pathology, Texas Children's Hospital, Houston, TX, USA.
Pract Lab Med. 2025 Jun 24;46:e00486. doi: 10.1016/j.plabm.2025.e00486. eCollection 2025 Sep.
Acute kidney injury (AKI) poses a serious clinical challenge, particularly in high-risk environments, due to its association with increased morbidity and mortality. Traditional diagnostic markers, such as serum creatinine, often detect AKI only after significant kidney damage has occurred, limiting opportunities for early intervention. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a promising early biomarker due to its rapid upregulation following kidney ischemia. NGAL supports renal recovery by reducing toxicity and promoting tubular regeneration via heme oxygenase-1 activity. This study aimed to validate the BioPorto ProNephro AKI™ turbidimetric immunoassay for urinary NGAL on the Ortho Vitros XT7600 analyzer and evaluate its clinical utility in detecting early-stage AKI.
Assay performance was evaluated in accordance with CLSI guidelines, assessing precision, linearity, method agreement, specificity, and reference range. Method comparison involved 20 urine samples, while reference range verification used 57 pediatric samples. A clinical validation study included 21 pediatric CRRT patient samples to assess real-world diagnostic performance.
The assay demonstrated strong precision (intra-assay CV: 1.3-1.8 %; inter-assay CV: 1.8-2.7 %) and excellent linearity (18-1140 ng/mL; extended to 15,000 ng/mL with dilution). High correlation (r = 0.9836) was observed in method comparison. Specificity tests showed minimal interference. Clinical validation yielded 76.19 % sensitivity and 100 % specificity for AKI detection.
The BioPorto ProNephro AKI™ assay on the Ortho Vitros XT7600 shows high sensitivity and specificity for urinary NGAL detection in pediatric patients, enabling early AKI identification, timely intervention, and potentially improved clinical outcomes through enhanced diagnostic performance.
急性肾损伤（AKI）是一项严峻的临床挑战，尤其是在高风险环境中，因为它与发病率和死亡率的增加相关。传统的诊断标志物，如血清肌酐，往往在肾脏发生显著损伤后才检测到AKI，限制了早期干预的机会。中性粒细胞明胶酶相关脂质运载蛋白（NGAL）已成为一种有前景的早期生物标志物，因为它在肾脏缺血后迅速上调。NGAL通过降低毒性并通过血红素加氧酶-1活性促进肾小管再生来支持肾脏恢复。本研究旨在验证在Ortho Vitros XT7600分析仪上用于检测尿NGAL的BioPorto ProNephro AKI™比浊免疫测定法，并评估其在检测早期AKI中的临床效用。
根据临床和实验室标准协会（CLSI）指南评估测定性能，评估精密度、线性、方法一致性、特异性和参考范围。方法比较涉及20份尿液样本，而参考范围验证使用57份儿科样本。一项临床验证研究纳入了21份儿科连续性肾脏替代治疗（CRRT）患者样本，以评估实际诊断性能。
该测定法显示出高精密度（批内变异系数：1.3 - 1.8%；批间变异系数：1.8 - 2.7%）和出色的线性（18 - 1140 ng/mL；稀释后可扩展至15,000 ng/mL）。方法比较中观察到高度相关性（r = 0.9836）。特异性测试显示干扰极小。临床验证对AKI检测的灵敏度为76.19%，特异性为100%。
在Ortho Vitros XT7600上的BioPorto ProNephro AKI™测定法对儿科患者尿NGAL检测具有高灵敏度和特异性，能够早期识别AKI，及时进行干预，并通过提高诊断性能潜在地改善临床结局。
