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The majority of the issues occurred during the analysis of microorganisms, and it is possible that this was caused by the limited capability of the classification software 14. In comparison to the Iris iQ200 8, Chein et al. discovered bacteria in the majority of samples through microscopic examination. The images of small cocci detected by the Iris iQ200, according to some researchers, were difficult for a medical technologist to classify as "bacteria," with the exception of some rod forms (12, 19). Other studies have suggested that manual microscopy should be used to confirm the presence of bacteria in the sample 20, 21. When comparing the FUS-200 analyzer to urine analyzer culture as the reference method, Koçer et al. discovered that it had low detection sensitivity 21. In line with other studies, we discovered bacteria in significantly more samples using manual microscopy than we did using instruments. The automated microscopic urine analysis analyzers, on the other hand, count both live and dead bacterial particles, resulting in higher particle counts. This is a limitation of all automated microscopic urine analysis analyzers when compared to culture-based methods of detection.
FUS-200 and Iris iQ200 analyzers have recently been approved for use in medical laboratories for the microscopic examination of urine. To our knowledge, this is the first study to compare the FUS-200 and the Iris iQ200 in terms of performance. Both instruments make use of technology that is similar.
To compare manual microscopic examination with automatic analyzers according to the clinical decision limit, we classified the cellular elements in our study according to their clinical significance.
The concordance between the manual method and the two instruments for clinically positive results ranged from good to moderate for erythrocytes, leukocytes, epithelial cells, bacteria, and crystals, with the manual method being the most accurate. In the case of yeast, the concordance between the manual method and the instruments was acceptable. In the case of casts, there was no agreement between any of the methods. The concordance between the two instruments was, on the whole, better than the concordance between the two instruments and the manual method for all cells.
4.1. Erythrocytes, leukocytes, and epithelial cells are the three types of blood cells.
As demonstrated by Chein et al. 8, there was good correlation between the Iris iQ200 and manual microscopy in the case of erythrocytes and leukocytes, respectively. The cell counts of the Iris iQ200 were higher than those of the manual method even though there was no statistical difference between the two methods at high erythrocyte and leukocyte counts, despite the fact that there was no statistical difference between the methods.
Many steps in the manual method, such as centrifugation, decantation, and re-suspension, have the potential to cause cellular lysis and death. There has been a good correlation reported between the Iris iQ200 and manual cell counts for erythrocytes, leukocytes, and epithelial cells in various studies 9, 10, 11, however, the Iris iQ200 found fewer cells than manual methods in one study 10.
Budak and colleagues discovered that the accuracy of leukocyte counting by instruments is higher than that of the manual method 12. The Iris iQ200 automatically resuspends particles by injecting a bolus of air into each sample prior to testing, ensuring that particles are properly suspended. Because of this, cellular clumps may be dissociated and cell counts that are higher than those recorded by manual counting methods may be obtained.
Akgün et al. discovered that the Iris iQ200 was more accurate at erythrocyte and leukocyte counting than manual methods, but that it was less accurate at epithelial cell counting than manual methods. This is due to the fact that the Iris iQ200 does not count deformed epithelial cells (see Figure 13). In our classification, there was a good agreement between the manual method and the two instruments used to analyze leukocytes and epithelial cells, respectively. The instruments, on the other hand, detected lower cell counts in the manual method's 6–10 cells/HPF range than the manual method. In the order of erythrocytes > leukocytes > epithelial cells, the relative agreement rate between the methods was the highest. 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, but they were lower when it came to epithelial cells.
Similarly to our findings, the detection sensitivity of the Iris iQ200 for erythrocytes and leukocytes (70% and 76%, respectively) was found to be comparable to those found in the study by Shayanfar et al. 14. Similarly, a separate investigation determined that the Iris Iq200 had 75.8% and 85.5% sensitivities for erythrocytes and leukocytes, respectively 15. According to our findings, the Iris iQ200 demonstrated excellent diagnostic sensitivity and specificity for all elements with the exception of epithelial cells in our study.
Aerial photographs of the morphological structures are taken by the automated instruments. It is possible that they will count distorted and disrupted cells as artefacts even if the leukocytes are damaged. In their study, Shayanfar et al. found that when abnormal erythrocytes such as ghosts and dysmorphic cells are present, the Iris iQ200 counts significantly fewer erythrocytes 14. It is possible that falsely high erythrocyte counts will occur in some cases as a result of a misclassification of yeasts. Wah and colleagues (Wah et al., 2010) reported similar false positive results. It is therefore necessary to analyze urine analyzer samples taken from patients suffering from kidney disorders using manual microscopy (16).
In contrast to our findings, Dewulf et al. 17 discovered that the Iris iQ200 had 95% and 100% sensitivities for erythrocyte and leukocyte, respectively, and that the negative predictive values were 93% and 100%, respectively, for these two cell types. Because of the low specificity and positive predictive value for erythrocytes (24% and 42%, respectively), they hypothesized that the manual method used for comparison was insensitive (17).
Yüksel et al. 18 discovered that the sensitivity of the Dirui FUS-100 for erythrocytes and leukocytes (73% and 68%, respectively) was similar to that found in our research. Additionally, it was discovered that the concordance between the FUS-100 and the Urised analyser was better than that of manual microscopy.
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