title: Accuracy and clinical correlates of two different methods for chromogranin A assay in neuroendocrine tumors.
abstract: Measurement of chromogranin A (CgA) plays a major role in the management of neuroendocrine tumors (NET); however, reliable assaying of CgA is made difficult by the rapid hydrolysis following its release into the bloodstream. This study was aimed at the assessment of two assays for CgA in NET patients. CgA was measured in 93 patients by means of an enzyme-linked immunosorbent assay (ELISA) and an immunoradiometric assay (IRMA). The specificity and sensitivity of CgA were evaluated in relation to tumor histology. The clinical accuracy of the two assays was evaluated by receiver-operating characteristic (ROC) curve analysis. Regression analysis demonstrated different immunoreactivity for CgA of the antibodies used in the two kits (r = 0.61). The two assays had different accuracy also in classifying patients according to their clinical condition (91% vs 64% specificity and 79% vs 79% sensitivity for the ELISA and IRMA assay, respectively) and tumor histology (81% vs 85% sensitivity for the ELISA and IRMA assays, respectively, in carcinoids; 92% vs 67% sensitivity for the ELISA and IRMA assays, respectively, in pancreatic islet cell tumors). The different clinical accuracy of the two assays was confirmed by the ROC analysis (AUC = 0.90 vs AUC = 0.87 for the ELISA and IRMA assays, respectively). In conclusion, because of the poor standardization of the commercially available measurement tools the clinical accuracy of CgA measurement depends on the assay used. This makes it difficult to compare CgA values measured with different kits and affects the clinical accuracy of the different assays for CgA.
authors.affiliation: Nuclear Medicine Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Ferrari
authors.forename: E
authors.initials: E
authors.lastname: Seregni
authors.forename: G
authors.initials: G
authors.lastname: Lucignani
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: A
authors.initials: A
authors.lastname: Martinetti
authors.forename: G
authors.initials: G
authors.lastname: Aliberti
authors.forename: F
authors.initials: F
authors.lastname: Pallotti
authors.forename: G
authors.initials: G
authors.lastname: Procopio
authors.forename: S
authors.initials: S
authors.lastname: Della Torre
authors.forename: R
authors.initials: R
authors.lastname: Luksch
authors.forename: E
authors.initials: E
authors.lastname: Bombardieri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers; D014408:Biomarkers, Tumor / Q000032:analysis*; D002276:Carcinoid Tumor / Q000378:metabolism; D002624:Chemistry, Clinical / Q000379:methods*; D002648:Child; D053379:Chromogranin A; D002864:Chromogranins / Q000032:analysis* / Q000378:metabolism; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007515:Islets of Langerhans / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000378:metabolism*; D012372:ROC Curve; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D015415:Biomarkers; D014408:Biomarkers, Tumor; C506150:CHGA protein, human; D053379:Chromogranin A; D002864:Chromogranins