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Background: Urinalysis is the third major test in clinical laboratory. Manual technique imprecision urges the need for a rapid reliable automated test. We evaluated the H800-FUS100 automatic urine sediment analyzer and compared it to the manual urinalysis technique to determine if it may be a competitive substitute in laboratories of central hospitals.
Methods: 1000 urine samples were examined by the two methods in parallel. Agreement, precision, carry-over, drift, sensitivity, specificity, and practicability criteria were tested.
Results: Agreement ranged from excellent to good for all urine semi-quantitative components (K > 0.4, p = 0.000), except for granular casts (K = 0.317, p = 0.000). Specific gravity results correlated well between the two methods (r = 0.884, p = 0.000). RBCS and WBCs showed moderate correlation (r = 0.42, p = 0.000) and (r = 0.44, p = 0.000), respectively. The auto-analyzer's within-run precision was ≥ 75% for all semi-quantitative components except for proteins (50% precision). This finding in addition to the granular casts poor agreement indicate the necessity of operator interference at the critical cutoff values. As regards quantitative contents, RBCs showed a mean of 69.8 ± 3.95, C.V. = 5.7, WBCs showed a mean of 38.9 ± 1.9, C.V. = 4.9). Specific gravity, pH, microalbumin, and creatinine also showed good precision results with C.Vs of 0.000, 2.6, 9.1, and 0.00 respectively. In the between run precision, positive control showed good precision (C.V. = 2.9), while negative control's C.V. was strikingly high (C.V. = 127). Carryover and drift studies were satisfactory. Manual examination of interobserver results showed major discrepancies (< 60% similar readings), while intra-observer's results correlated well with each other (r = 0.99, p = 0.000).
Conclusions: Automation of urinalysis decreases observer-associated variation and offers prompt competitive results when standardized for screening away from the borderline cutoffs.
DOI: 10.7754/Clin.Lab.2015.150520
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