Because of the limited capability of the classification software 14, it is possible that the majority of the problems occurred during the microorganism analysis phase. Through microscopic examination, Chein et al. discovered bacteria in the majority of samples when compared to the Iris iQ200 8 used in their previous study. According to some researchers, the images of small cocci captured by the Iris iQ200 were difficult for a medical technologist to distinguish from bacteria, with the exception of some rod forms (12, 19). Manual microscopy has been recommended in other studies to confirm the presence of bacteria in the sample 20, 21, according to the findings of those studies. According to Koçer et al., when they compared the FUS-200 analyzer to urine culture as a reference method, they discovered that it had low detection sensitivity 21 (Figure 1). Our findings were consistent with other studies in that we discovered bacteria in significantly more samples when using manual microscopy rather than instruments. Automatic urine analyzers, on the other hand, count both live and dead bacteria, resulting in significantly higher particle counts than manual microscopic urine analysis analyzers. When compared to culture-based methods of detection, this is a limitation of all automated urine analyzers, which is a common occurrence.
Recent FDA approval for the use of FUS-200 and Iris iQ200 urine analyzers in medical laboratories for the microscopic examination of urine analyzer has been granted. To our knowledge, this is the first study to compare the performance of the FUS-200 and the Iris iQ200 in terms of functionality. It is the technology used by both instruments that is comparable.
We classified the cellular elements in our study according to their clinical significance in order to compare manual microscopic examination with automatic analyzers according to the clinical decision limit.
Clinically positive results were found to be consistent between the manual method and the two instruments in all cases except one, where they were inconsistent. The manual method was the most accurate in all cases except one, where it was inconsistent with the two instruments in all cases except one, where it was accurate with both instruments in all cases except one. It was found that the agreement between the manual method and the instruments was acceptable in the case of yeast. There was no agreement between any of the methods when it came to casting. Across all cells, the concordance between the two instruments was significantly better than the concordance between the two instruments and the manual method on the whole.
The three types of blood cells are erythrocytes, leukocytes, and epithelial cells, as listed in Table 4.1.
As demonstrated by Chein et al. 8 in the case of erythrocytes and leukocytes, there was a high degree of agreement between the Iris iQ200 and manual microscopy when comparing the two methods. Cell lysis and death are possible outcomes of many steps in the manual method. These include centrifugation, decantation, and re-suspension, to name a few examples. It was discovered by Budak and colleagues that the accuracy of leukocyte counting by instruments is higher than that of the manual method 12 (see Figure 1). Particles are automatically resuspended by injecting a bolus of air into each sample prior to testing. This ensures that particles are properly suspended throughout the entire testing process. In their study, Akgün et al. discovered that the Iris iQ200 was more accurate than manual methods at counting erythrocytes and leukocytes, but that it was less accurate at counting epithelial cells than manual methods in epithelial cell counting. There was good agreement in our classification between the manual method and the two instruments that were used to analyze leukocytes and epithelial cells, respectively. It was found that the relative agreement rate between the methods was highest in the following order: erythrocytes > leukocytes > epithelial cells. When it came to erythrocytes and leukocytes, the concordances between the Iris iQ200 and manual method were higher than when it came to the FUS-200 and manual method; however, when it came to epithelial cells, they were lower than when it came to the FUS-200 and manual method.
Separate research determined that the Iris Iq200 had erythrocyte and leukocyte sensitivities of 75.8% and 85.5%, respectively, according to the results of a separate study 15. We discovered that the Iris iQ200 had excellent diagnostic sensitivity and specificity for all elements in our study, with the exception of epithelial cells, according to our findings.
It is possible that they will classify distorted and disrupted cells as artefacts even if the leukocytes have been damaged in the process. When abnormal erythrocytes such as ghosts and dysmorphic cells are present, the Iris iQ200 counts significantly fewer erythrocytes, according to the findings of Shayanfar and colleagues 14. Wah and colleagues (Wah et al., 2010) reported results that were similar to these false positives. As a result, manual microscopy (16) is required for the analysis of microscopic urine analysis samples obtained from patients suffering from kidney disorders.
According to their findings, Dewulf et al. 17 discovered that the Iris iQ200 had sensitivity of 95% and specificity of 100% for erythrocytes and leukocytes, respectively, and that the negative predictive values for these two cell types were 93% and 100%, respectively, in contrast to our findings. They hypothesized that the manual method used for comparison was insensitive (17) because of the low specificity and positive predictive value for erythrocytes (24% and 42%, respectively). They were correct.
It was discovered by Yüksel et al. 18 that the Dirui FUS-100 was sensitive to both erythrocytes and leukocytes with 73% and 68% sensitivity, respectively, which was similar to the results of our research. Also discovered was that the concordance between the FUS-100 and the Urised analyser was superior to that of manual microscopy.
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