Evaluation of the fully automated urine particle analyzer UF‐1500

Background and Aims This study primarily assessed the performance of the UF‐1500, the novel and compact model of the fully automated urine particle analyzer and evaluated its performance against the existing UF‐5000 instrument. Materials and Methods A total of 648 residual urine specimens were randomly collected and examined using both the UF‐1500 and UF‐5000 instruments as well as manual microscopy. For each parameter, the concordance rates and detection accuracy of the UF‐1500 against manual microscopy were compared with the UF‐5000. Results The concordance rates between the UF‐1500 and manual microscopy were 75.3%–98.5%. The UF‐1500 concordance rates within one group agreement were observed to be >90%, for all parameters except for YLCs. The differences within one group agreement between the UF‐1500 and manual microscopy were insignificant, in comparison to the UF‐5000, with exceptions noted for ECs and YLCs. The sensitivity and specificity of the UF‐1500 for RBCs, WBCs, Squa.ECs, and BACT exceeded 80%, while the positive predictive values of ECs and CASTs were below 70%. Conclusion The UF‐1500 exhibited a performance that was comparable to the existing instrument, the UF‐5000, and was suitable to be introduced in clinical practice. For the samples with suspected false‐positive or false‐negative results, a manual microscopic examination is required for accurate testing. The novel and compact model of the fully automated urine particle analyzer UF‐1500 was evaluated. The performance of the UF‐1500 is comparable to that of the existing UF‐5000 analyzer. The UF‐1500 was suitable to be introduced in clinical practice, but a manual microscopic examination is necessary for the samples with false‐positive or false‐negative results.