RESUMEN
We checked analytical performances of Optilite® analyser for immunoglobulins G, A, M, subclasses of IgG, free light chains of Ig (Freelite®) and complement's fractions using Binding Site reagents. CVs for repeteability and reproducibility showed very good results, respectively <3% and <10% for all tested parameters, in agreement with Ricos and SFBC recommendations. Comparisons with results obtained on BN™II (Siemens) or SPAPLUS ® (Binding site) analysers showed a good agreement (>83%) according to Bland and Altman analysis. Sample throughput with either a batch of Freelite® only or Freelite® and immunoglobulins showed a gain of total realisation time on Optilite® versus BN™II. Optilite® analyser performed automatic dilutions until result and antigen excess determination for parameters as Freelite® or IgG4. In terms of practicability, traceability and maintenance, Optilite® turbidimeter alone or connected to LIS via DataSite software is well adapted to specialized laboratory for proteins determinations.
Asunto(s)
Automatización de Laboratorios/instrumentación , Técnicas de Laboratorio Clínico , Inmunoglobulinas/metabolismo , Proteínas/análisis , Proteínas/metabolismo , Automatización de Laboratorios/normas , Sitios de Unión , Técnicas de Laboratorio Clínico/instrumentación , Técnicas de Laboratorio Clínico/métodos , Técnicas de Laboratorio Clínico/normas , Humanos , Inmunoglobulinas/análisis , Pruebas Inmunológicas/instrumentación , Pruebas Inmunológicas/métodos , Límite de Detección , Nefelometría y Turbidimetría/instrumentación , Nefelometría y Turbidimetría/métodos , Proteínas/química , Juego de Reactivos para Diagnóstico/normas , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Programas Informáticos/normasRESUMEN
BACKGROUND: Hepatitis C virus (HCV) is associated with B-cell disorders, including mixed cryoglobulinemia (MC) and B-cell non-Hodgkin lymphoma (B-NHL). We hypothesized that combination of serum biomarkers could be used to identify B-NHL in HCV patients. METHODS: We measured in 155 HCV infected patients, with and without MC and/or B-NHL, serum levels of eight markers previously described to be increased in patients with B-NHL, i.e. sCD22, sCD27, sIL-2Rα, sCD137, free-light chains of Ig (ratio κ/λ), heavy chains of Ig (ratio IgMκ/IgMλ), gammaglobulins and C4. We used a multiparametric analysis to determine a signature that identifies patients with overt B-NHL. RESULTS: Serum levels were significantly different between patients without MC, patients with asymptomatic MC, patients with MC vasculitis and those with MC vasculitis and B-NHL for all biomarkers except for sCD137. Using multiparametric analysis, we identified a signature involving sCD27, sIL-2Rα, gammaglobulins and C4 levels associated with the presence of overt B-NHL in HCV-infected patients. This signature had a sensitivity of 100%, a specificity of 90%, and positive and negative predictive values of 97 and 100%, respectively for discriminating patients with overt B-NHL and those without B-NHL. CONCLUSION: Our data indicate that serum biomarker signature allows identifying HCV-infected patients presenting with overt B-NHL.
