College of Life Sciences and Medicine, Zhejiang Sci-Tech University, Hangzhou, China.
Wuxi People's Hospital affiliated to Nanjing Medical University, Wuxi, China.
J Clin Lab Anal. 2022 Sep;36(9):e24603. doi: 10.1002/jcla.24603. Epub 2022 Jul 23.
To establish a highly sensitive time-resolved fluorescence immunoassay (TRFIA) of kidney injury molecule-1 (Kim-1) and evaluate its clinical value in acute kidney injury (AKI).
The Kim-1-TRFIA was established by the double-antibody sandwich method, and the method was evaluated. The established Kim-1-TRFIA was used to detect the concentration of Kim-1 in the serum of healthy controls and patients with AKI.
The optimal coating antibody concentration and optimal Eu -labeled antibody dilution ratio for Kim-1-TRFIA are 1 μg/ml and 1:140, respectively. The linear range is 42.71-4666.69 pg/ml. The intra- and inter-assay coefficients of variation are <10%. The specificity of our Kim-1-TRFIA is acceptable. The recovery is between 95.14% and 102.84%. The concentration of Kim-1 in the serum of patients with AKI is 126.50 ± 67.99 pg/ml, which is significantly higher than that in the serum of healthy controls (49.72 ± 16.40 pg/ml, p < 0.001). Staging patients with AKI by glomerular filtration rate shows that the serum concentration of Kim-1 increases significantly with increasing disease severity (p < 0.05).
A highly sensitive Kim-1-TRFIA was established. With this immunoassay, a good differential diagnosis can be made, and healthy people and AKI patients can be differentiated by detecting the concentration of Kim-1 in the serum. Moreover, the severity of AKI patients can be determined.
建立一种高灵敏度的肾损伤分子-1（Kim-1）时间分辨荧光免疫分析（TRFIA）方法，并评估其在急性肾损伤（AKI）中的临床价值。
采用双抗体夹心法建立 Kim-1-TRFIA 方法，并对其进行评价。用建立的 Kim-1-TRFIA 检测健康对照者和 AKI 患者血清中 Kim-1 的浓度。
Kim-1-TRFIA 的最佳包被抗体浓度和最佳 Eu 标记抗体稀释比例分别为 1μg/ml 和 1:140。线性范围为 42.71-4666.69pg/ml。批内和批间变异系数均<10%。Kim-1-TRFIA 的特异性可接受。回收率在 95.14%-102.84%之间。AKI 患者血清中 Kim-1 的浓度为 126.50±67.99pg/ml，明显高于健康对照者（49.72±16.40pg/ml，p<0.001）。按肾小球滤过率对 AKI 患者进行分期显示，随着疾病严重程度的增加，血清 Kim-1 浓度显著升高（p<0.05）。
建立了一种高灵敏度的 Kim-1-TRFIA。通过该免疫分析方法，可以进行良好的鉴别诊断，通过检测血清中 Kim-1 的浓度可以区分健康人和 AKI 患者，并且可以判断 AKI 患者的严重程度。
