Chronic kidney disease (CKD) is a global disease that is harder to treat at a later stage. Therefore, early diagnosis and monitoring of CKD are crucial. T cell immunoglobulin and mucin domain molecule 3 (Tim‑3) is a negative regulator of the T cell responses and it is involved in the immunomodulation of kidney disease. To date, only a small number of reports regarding serum soluble Tim‑3 (sTim‑3) in CKD are available. In the present study, the serum levels of sTim‑3 in patients with CKD at different stages and the levels of sTim‑3 in the early diagnosis and monitoring of CKD were analyzed. A highly sensitive time‑resolved fluorescence immunoassay was performed to quantify sTim‑3 levels in 318 patients with CKD and 114 healthy individuals. The serum levels of sTim‑3 in patients with CKD (33.47±20.77 ng/ml) were significantly higher than those in the healthy individuals group (8.32±3.23 ng/ml; P<0.0001). As CKD progressed from stage G1 to G5, the serum sTim‑3 level gradually increased (P<0.0001). A cut‑off value of 13.63 ng/ml for the sTim‑3 concentration was effective in diagnosing patients with CKD (area under the receiver operating characteristic curve, 0.9176; sensitivity, 79.87%; specificity, 96.49%). At this critical value, the positive detection rate of CKD in the early stages (G1 + G2), G3, G4 and G5 was 55.70, 77.78, 84.44 and 92.86%, respectively. In conclusion, the serum sTim‑3 levels in patients with CKD were significantly higher than those in the healthy individuals group. As CKD progressed from G1 to G5, the serum sTim‑3 concentration gradually increased, facilitating the monitoring of the progression of CKD. In addition, serum sTim‑3 had an auxiliary effect that was useful in the early diagnosis of CKD. The positive detection rate of CKD in the early stages was 55.70%, which can assist other clinically common kidney disease indicators.

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