title: Mesothelin family proteins and diagnosis of mesothelioma: analytical evaluation of an automated immunoassay and preliminary clinical results.
abstract: BACKGROUND
  Studies have suggested that soluble mesothelin-related protein (SMRP) can be used as a serum marker of malignant mesothelioma.
  
  
  METHODS
  We assessed the analytical performance of the Mesomark (Fujirebio Diagnostic) two-step ELISA on an automated analyser and performed a preliminary clinical evaluation. The precision of the assay and the in vitro effect of interfering substances on SMRP concentrations were investigated. The serum marker was analysed in 109 healthy subjects never exposed to asbestos, 26 healthy subjects exposed to asbestos, 33 patients with asbestosis, 33 with asbestos-related pleural plaques, 10 with non-malignant pleural diseases, 30 with lung cancer and 24 with histological diagnosis of pleural mesothelioma.
  
  
  RESULTS
  Using the International Mesothelioma Interest Group classification, there were nine stage IV, two stage III, four stage II and nine stage I patients. SMRP concentrations of 4.75, 11.0 and 14 nmol/mL showed a total imprecision of 3.5%, 3.1% and 3.8%. The detection limit was 0.035 nmol/mL; the mean SMRP concentration of 0.63 nmol/mL was associated with a coefficient of variation of 10%. There was no effect (p>0.05) of interfering substances. Serum samples from patients with established pleural mesothelioma had significantly higher (p<0.05) concentrations of SMRP than control healthy and patient groups.
  
  
  CONCLUSIONS
  SMRP measured on automated systems could be useful for the diagnosis of mesothelioma in routine clinical practice.
authors.affiliation: Department of Clinical Pathology I, University Hospital of Bari, Bari, Italy. diseriofrancesca@tiscali.it
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Serio
authors.forename: Antonietta
authors.initials: A
authors.lastname: Fontana
authors.forename: Michele
authors.initials: M
authors.lastname: Loizzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Capotorto
authors.forename: Piera
authors.initials: P
authors.lastname: Maggiolini
authors.forename: Ernesto
authors.initials: E
authors.lastname: Mera
authors.forename: Lucia
authors.initials: L
authors.lastname: Bisceglia
authors.forename: Raffaele
authors.initials: R
authors.lastname: Molinini
mesh_terms: D000368:Aged; D001331:Automation; D014408:Biomarkers, Tumor; D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D005260:Female; D058851:GPI-Linked Proteins; D006801:Humans; D008297:Male; D008562:Membrane Glycoproteins / Q000097:blood*; D000090204:Mesothelin; D008654:Mesothelioma / Q000175:diagnosis*; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D058851:GPI-Linked Proteins; D008562:Membrane Glycoproteins; D000090204:Mesothelin