Evaluation of the fully automated urine particle analyzer UF-1500.

Abstract

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.