title: Comparison of automated devices UX-2000 and SediMAX/AutionMax for urine samples screening: A multicenter Spanish study.
abstract: OBJECTIVE
  In this study we aim to compare UX2000 (Sysmex Corp, Japan) and SediMAX/AutionMax (Arkray Factory Inc., Japan), totally automatized analyzers, against Fuchs-Rosenthal counting chamber, the gold standard technique for sediment analysis.
  
  
  METHODS
  Urine samples of 1454 patients from three Spanish hospitals were assessed for red and white blood cells (RBC; WBC) using three different techniques: flow cytometry, image-based method and Fuchs-Rosenthal counting chamber. Test strip results were subjected to concordance evaluation. Agreement was assessed by Cohen's weighted kappa for multinomial results. Sensitivity (SE) and specificity (SP) were calculated.
  
  
  RESULTS
  The categorization of the results showed that UX-2000 had higher concordance over SediMAX for WBC (0.819 vs. 0.546) and similar for RBC (0.573 vs. 0.630). For RBC, UX-2000 had higher SE (92.7% vs. 80.3%) but lower SP (77.1% vs. 87.4%), and showed higher both SE (94.3% vs. 76.7%) and SP (94.7% vs. 88.2%) for WBC. Inter-devices test strip agreement was substantial (kappa>0.600) for all variables except for bilirubin (kappa: 0.598). Intra-device test strip agreement was similar for UX2000 and SediMAX with regard to RBC (kappa: 0.553 vs. 0.482) but better for UX2000 with regard to WBC (0.688 vs. 0.465).
  
  
  CONCLUSIONS
  Both analyzers studied are acceptable for daily routine lab work, even though SediMAX is easier to use in laboratories thanks to its lower maintenance procedure. UX-2000 has shown to have better concordance with the gold standard method. However, it needs some improvements such as an image module in order to decrease manual microscopy review for urine samples.
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain. Electronic address: catalina.sanchez.mora.sspa@juntadeandalucia.es.
authors.forename: Catalina
authors.initials: C
authors.lastname: Sánchez-Mora
authors.affiliation: Clinical Biochemistry Department, Clinical Analysis Service, Dr. Peset University Hospital, Valencia, Spain.
authors.forename: Delia
authors.initials: D
authors.lastname: Acevedo
authors.affiliation: Clinical Analysis Department, Jiménez Díaz Foundation University Hospital, Madrid, Spain.
authors.forename: Maria Amelia
authors.initials: MA
authors.lastname: Porres
authors.affiliation: Clinical Biochemistry Department, Clinical Analysis Service, Dr. Peset University Hospital, Valencia, Spain.
authors.forename: Ana María
authors.initials: AM
authors.lastname: Chaqués
authors.affiliation: Microbiology Department, Jiménez Díaz Foundation University Hospital, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zapardiel
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Aurelia
authors.initials: A
authors.lastname: Gallego-Cabrera
authors.affiliation: Clinical Biochemistry Department, Clinical Analysis Service, Dr. Peset University Hospital, Valencia, Spain.
authors.forename: Jose María
authors.initials: JM
authors.lastname: López
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Jose María
authors.initials: JM
authors.lastname: Maesa
mesh_terms: D000328:Adult; D000368:Aged; D057205:Automation, Laboratory / Q000592:standards*; D004636:Emergency Service, Hospital; D004906:Erythrocyte Count / Q000295:instrumentation / Q000592:standards*; D004912:Erythrocytes / Q000473:pathology; D005260:Female; D006801:Humans; D007297:Inpatients; D007958:Leukocyte Count / Q000295:instrumentation / Q000592:standards*; D007962:Leukocytes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D013030:Spain; D016482:Urinalysis / Q000295:instrumentation* / Q000379:methods
keywords: Aution max; SediMAX; Sediment; Test strips; UX-2000; Urine screening