Mitochondrial diseases (MDs) are occasionally difficult to diagnose. Growth differentiation factor 15 (GDF15) has been reported as a biomarker useful for not only diagnosing MDs, but also evaluating disease severity and therapeutic efficacy. To enable the measurement of serum GDF15 concentrations at medical institutions, we developed a new latex‐enhanced turbidimetric immunoassay (LTIA) as an automated diagnostic indication test for MDs. We also examined the equivalency of specificity and sensitivity in measuring serum GDF15 concentrations between a commercially available enzyme‐linked immunosorbent assay (ELISA) kit and a novel LTIA device in patients with MDs, disease controls, and healthy controls. A clinical performance study used a newly developed LTIA device and an existing ELISA kit to measure the concentrations of GDF15 in 35 MD patients, 111 disease controls, and 86 healthy controls. The median (first quartile‐third quartile) of serum GDF15 concentrations measured with the LTIA device was significantly higher (P < .001) in MD patients (1389.0 U/mL [869.5‐1776.0 U/mL]) than in healthy controls (380.5 U/mL [330.2‐471.8 U/mL]); the interquartile ranges did not overlap between MD patients and healthy controls. The areas under the curve in disease and healthy controls were 0.812 (95% confidence interval [CI]: 0.734‐0.886) and 0.951 (95% CI: 0.910‐0.992), respectively. The automated, high‐throughput technology‐based LTIA device has definite advantages over the ELISA kit in shorter processing time and lower estimated cost per sample measurement. The LTIA device of GDF15 may be a sufficiently reliable, frontline, diagnostic indicator of individuals with suspected MDs in the general population.

中文翻译：

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一种新的线粒体疾病生物标志物生长分化因子15诊断指示装置：从实验室到自动化检测

线粒体疾病 (MD) 有时难以诊断。据报道，生长分化因子 15 (GDF15) 是一种生物标志物，不仅可用于诊断 MD，还可用于评估疾病严重程度和治疗效果。为了能够在医疗机构测量血清 GDF15 浓度，我们开发了一种新的乳胶增强免疫比浊法 (LTIA) 作为 MD 的自动诊断指征测试。我们还检查了市售酶联免疫吸附测定 (ELISA) 试剂盒和新型 LTIA 设备在 MD 患者、疾病对照者和健康对照者中测量血清 GDF15 浓度的特异性和灵敏度的等效性。一项临床性能研究使用新开发的 LTIA 设备和现有的 ELISA 试剂盒来测量 35 名 MD 患者的 GDF15 浓度，疾病对照者111人，健康对照者86人。用 LTIA 设备测量的血清 GDF15 浓度的中位数（第一个四分位数 - 第三个四分位数）显着更高（P  < .001) MD 患者 (1389.0 U/mL [869.5-1776.0 U/mL]) 与健康对照 (380.5 U/mL [330.2-471.8 U/mL]) 相比；MD 患者和健康对照之间的四分位距没有重叠。疾病和健康对照的曲线下面积分别为 0.812（95% 置信区间 [CI]：0.734-0.886）和 0.951（95% CI：0.910-0.992）。与 ELISA 试剂盒相比，基于自动化、高通量技术的 LTIA 设备在更短的处理时间和更低的每个样本测量估计成本方面具有明显的优势。GDF15 的 LTIA 设备可能是一般人群中疑似 MD 个体的足够可靠的前线诊断指标。