Mid-stream vs. first-voided urine collection by using automated analyzers for particle examination in healthy subjects: an Italian multicenter study.

BACKGROUND: In analogy with other areas of laboratory diagnostics, the pre-analytical phase is the leading source of variability also in urinalysis. We carried out a multicentric study for comparing results obtained from first-voided and mid-stream urine samples. METHODS: Each of the six hospital-based clinical laboratories participating to this study recruited 50 healthy subjects among laboratory staff and/or their relatives. Two consecutive samples of the first morning micturition were collected by vacuum system, the first from the first-void and the second from the mid-stream. Routine urinalysis was performed using dip-stick automated analyzers for chemical examination and automated analyzers for formed particle examination (Sysmex UF-100, Sysmex UF-1000i and Iris iQ-200). RESULTS: Counts of epithelial cells (EC), erythrocytes (ERY) and leukocytes (LEU) but not for cylinders (CAS) were significantly higher in the first-voided samples. A significantly higher count of EC, ERY and LEU was also observed between females and males in first-voided samples, whereas no significant difference could be found in mid-stream samples. Health related analyzer specific upper reference limits (URL) were CAS≤1, EC≤5, ERY≤19, Leu≤13 for UF-100; CAS≤1, EC≤4, ERY≤15, Leu≤11 for UF-1000i; CAS≤1, EC≤4, ERY≤18, Leu≤10 for iQ200. The overall prevalence of subjects with cellular elements count exceeding URL was also higher in first-voided than in mid-stream samples. CONCLUSIONS: Mid-stream urine was confirmed as the most appropriate sample, since the presence of contaminating elements, such as bacteria, analytes and formed particles are minimized.

Cutoff values for bacteria and leukocytes for urine flow cytometer Sysmex UF-1000i in urinary tract infections.

Because urinary tract infections (UTIs) are a quite common disease, the gold standard for diagnosing UTIs is still bacterial culture, although a large percentage of samples are negative: unnecessary cultures can be reduced by means of an effective screening test. The analytic performance of a new urine cytometer, the UF-1000i, has been tested on 1463 urine samples submitted to our laboratory for culture. Bacteria and leukocyte counts have been compared by means of the UF-1000i with colony-forming unit (CFU) quantification on citrate lactose electrolytes deficient agar to assess the best cutoff values. By using quantitative cultures and considering as positive a sample with 10 x 10(5) CFU/mL, 546 positive samples (37%) were observed. If compared with 10 x 10(5) CFU/mL, the cutoff values obtained were 125 bacteria/microL and 40 leukocytes/ microL, respectively. Analytic parameters such as sensitivity, specificity, positive predictive value, negative predictive value, and correctly classified incidence were satisfactory. Based on the results obtained in this study, when using the UF-1000i analyzer for a screening test for UTI, a cutoff value of 40 white blood cells/microL should be adopted. The cutoff value for bacteria should be 125/microL for those clinical conditions in which 10 x 10(5) CFU/mL indicates a positivity.