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Lippi G.,Unita Operativa Diagnostica Ematochimica | Avanzini P.,Unita Operativa Diagnostica Ematochimica | Campioli D.,Laboratorio Analisi Chimico Cliniche | Da Rin G.,Struttura Complessa Medicina Of Laboratorio | And 4 more authors.
Clinical Biochemistry | Year: 2013

Objectives: Despite manufacturers' claim that systematical assessment of serum indices does not impact on testing efficiency, there is widespread perception that this practice may increase the turnaround time (TAT). A multicenter investigation was planned to verify TAT and performance of serum indices on five different clinical chemistry analyzers. Design and methods: Twenty study samples prepared from pooled sera of outpatients, emergency department, intensive care unit and dialyzed patients were divided in aliquots and shipped to 5 different laboratories. According to local instrumentation (Beckman Coulter AU5800, Roche Cobas 6000, Siemens Dimension Vista 1500, Abbott Architect c 16000 and Ortho Vitros 5.1/FS) and reagents, 13 clinical chemistry parameters were assayed on all study samples, with or without contextual assessment of serum indices. Results: The TAT with assessment of serum indices modestly or even negligibly increased, and varied from 0.2 to +. 5.0% (i.e., from 3 to +. 85. s). When using the lowest thresholds for sample acceptability, the agreement of hemolysis index (HI) among different instruments was comprised between 0.62 and 1.00 (all p. <. 0.01), but was higher than 0.80 in only 4/10 cases. The agreement of icteric and lipaemic indices could not be estimated due to the low number of samples exceeding acceptability criteria. Conclusions: The results of this study confirm that systematical measurement of serum indices does not impair instrument efficiency. The comparison of HI also suggests that major harmonization may be advisable for this measure among different manufacturers and instrumentations. © 2013 The Canadian Society of Clinical Chemists.

Dolci A.,Laboratorio Analisi Chimico Cliniche | Vernocchi A.,Centro Of Medicina Of Laboratorio E Anatomia Patologica Multilab
Biochimica Clinica | Year: 2012

Serum protein electrophoresis (SPE) is a screening test widely used in clinical practice to identify patients with monoclonal gammopathies. SPE, performed on agarose gel (AGE) or by capillary zone electrophoresis (CZE), is the only technique able to recognize a monoclonal immunoglobulin. To detect monoclonal components (MC), SPE must be visually inspected. The two available techniques show similar sensitivity for MC detection (CZE 95%, AGE 91%), with a higher specificity for AGE (99% vs. 78% for CZE). Any MC detected must be reported, because also small B-cell clones could be dangerous. Once detected, MCs need to be quantitatively measured directly on the SPE pattern by setting the limits of the corresponding peak. A concentration-related bias in MC quantitation between AGE and CZE exists. Immunotyping is the further mandatory test for confirmation and characterization of MC by either immunofixation (IFE) or immunosubtraction (ISE). In general, IFE is more sensitive than ISE, but high resolution (HRIFE) must be warranted. However, ~25% of IFE carried out on commercially available kits are difficult to interpret and thus not reportable. For identification of amyloidogenic light chain MC, sensitivity of the manual HR-IFE is 95% vs. 80% of conventional semiautomated assays. The recently introduced quantitative serum assay for immunoglobulin free light chains (FLC) is an accurate index of clonality, particularly for FLC myeloma and AL amyloidosis. To reach the highest sensitivity in MC detection a comprehensive screening panel including SPE, HR-IFE and FLC determination is recommended.

Ceriotti F.,Servizio Of Medicina Of Laboratorio | Brugnoni D.,Laboratorio Analisi Chimico Cliniche | Mattioli S.,Presidio
Clinical Chemistry and Laboratory Medicine | Year: 2015

Background: Internal quality control (IQC) is an everyday practice described in several documents. Its planning requires the definition of quality goals and a documentation system able to provide alarms as soon as the goals are not reached. We propose the use of the uncertainty approach to develop an effective alarm system. Methods: The use of the uncertainty information to verify the conformity to specifications is described. A top-down approach to the definition of the uncertainty of the method is described. Once the uncertainty is calculated, the complete measurement result (result±expanded uncertainty) is compared with the maximum permissible error (quality goal). An alternative and more immediate presentation is obtained defining an "acceptance zone" derived from the maximum permissible error reduced on either sides by expanded uncertainty. This approach is applied to two analytes: glucose and creatinine. Results: The relationship between quality goal and expanded uncertainty defines the width of the acceptance zone; if uncertainty is equal or larger than the quality goal, the goal is not attainable. Conclusions: The proposed approach uses an information, expanded uncertainty, that each laboratory seeking ISO 15189 accreditation should already have. The data presentation is immediate and easy to interpret allowing a direct comparison between the performance of the method and the quality goals. © 2015 by De Gruyter.

Perobelli S.,Cystic Fibrosis Center | Nicolis E.,Laboratorio Analisi Chimico Cliniche | Assael B.M.,Cystic Fibrosis Center | Cipolli M.,Cystic Fibrosis Center
American Journal of Medical Genetics, Part A | Year: 2012

To assess psychosocial functioning and quality of life in a representative group of adult and young patients with Shwachman-Diamond syndrome (SDS), all patients 3 years old and over included in the Italian SDS Registry were investigated using an ad-hoc questionnaire for information about demography, education, socialization, rehabilitation therapy, and standardized questionnaires [SF-36, Child Behavior Check-List (CBCL)] for quality of life and behavior. Results were compared with those of a Cystic Fibrosis (CF) patient group, matched for age and sex. Eighty-one percent of patients answered. All but one adult patient lived with their parents, 24% had independent income, and 57% had a driver's license. Different levels (from mild to severe) of cognitive impairment were reported by 76% of the adults and by 65% of the young patients. These data are significantly lower than those of the CF group. Both groups present low scores in the emotional and mental health evaluations at SF-36, but SDS patients reported significantly more limitations in physical functioning (PF) and more body pain (BP) experiences. As reported by parents at CBCL, young SDS patients show more "social problems" (in the clinical area 31% SDS vs. 6% CF), "attention deficits disorder" (29% SDS vs. 0%CF), and "somatic complaints" (24% SDS vs. 12% CF). Psychosocial functioning is impaired in the majority of SDS patients, significantly more than in patients affected by CF. © 2012 Wiley Periodicals, Inc.

Antico A.,Laboratorio Analisi Chimico Cliniche | Tampoia M.,Laboratorio Of Patologia Clinica | Villalta D.,Allergologia e Immunologia Clinica | Tonutti E.,Allergologia e Immunopatologia | And 2 more authors.
Clinical and Developmental Immunology | Year: 2012

Aim. To assess the predictive value for chronic autoimmune gastritis (AIG) of the combined assay of anti-parietal-cell antibodies (PCA), anti-intrinsic-factor antibodies (IFA), anti-Helicobacter pylori (Hp) antibodies, and measurement of blood gastrin. Methods. We studied 181 consecutive patients with anemia, due to iron deficiency resistant to oral replacement therapy or to vitamin B12 deficiency. Results. 83 patients (45.8%) tested positive for PCA and underwent gastroscopy with multiple gastric biopsies. On the basis of the histological diagnosis, PCA-positive patients were divided into 4 groups: (1) 30 patients with chronic atrophic gastritis; they had high concentrations of PCA and gastrin and no detectable IFA; (2) 14 subjects with metaplastic gastric atrophy; they had high PCA, IFA, and gastrin; (3) 18 patients with nonspecific lymphocytic inflammation with increased PCA, normal gastrin levels, and absence of IFA; (4) 21 patients with multifocal atrophic gastritis with "borderline" PCA, normal gastrin, absence of IFA and presence of anti-Hp in 100% of the cases. Conclusions. The assay of four serological markers proved particularly effective in the diagnostic classification of gastritis and highly correlated with the histological profile. As such, this laboratory diagnostic profile may be considered an authentic "serological biopsy." © 2012 Antonio Antico et al.

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