Henne V, Frei P, Bürgisser P
Roche Diagnostic Systems, Basel, Switzerland.
Anticancer Res. 1997 Jul-Aug;17(4B):2915-8.
The clinical evaluation of the Cobas Core beta 2-Microglobulin EIA was performed on the random access analyzer Cobas Core. The coefficients of variations for the intra-assay and inter-assay precisions ranged between 3% and 6%. In comparison to healthy persons (0.7-2.7 mg/l), significantly elevated serum levels of beta 2-m were found in patients with lymphoproliferative disorders like monoclonal gammopathies of the IgG (1.98-78 mg/l; p = 0.0001), IgA (1.3-7.1 mg/l; p = 0.0002) and of the IgM (2.1-8.7 mg/l; p = 0.0001) type, in malignant lymphoma (1.5-33.5 mg/l; p = 0.0001) and in chronic lymphatic leukemia (1.5-22.4 mg/l; p = 0.0001). In cases of HIV-infection, increasing levels of beta 2-m exhibited an inverse correlation to the CD4+ T-lymphocyte count (p = 0.0001) and indicated disease progression. In patients having renal transplantation a rejection of the graft was accompanied by a rise of the beta 2-m serum level. In summary, the data clearly indicate the reliability of the measuring system as well as the clinical relevance of beta-2-M determinations for such patient groups.
在随机存取分析仪Cobas Core上对Cobas Coreβ2-微球蛋白酶免疫测定法进行了临床评估。批内精密度和批间精密度的变异系数在3%至6%之间。与健康人(0.7 - 2.7毫克/升)相比,在患有淋巴细胞增殖性疾病的患者中发现β2 - m血清水平显著升高,如IgG型单克隆丙种球蛋白病(1.98 - 78毫克/升;p = 0.0001)、IgA型(1.3 - 7.1毫克/升;p = 0.0002)和IgM型(2.1 - 8.7毫克/升;p = 0.0001)、恶性淋巴瘤(1.5 - 33.5毫克/升;p = 0.0001)和慢性淋巴细胞白血病(1.5 - 22.4毫克/升;p = 0.0001)。在HIV感染病例中,β2 - m水平升高与CD4 + T淋巴细胞计数呈负相关(p = 0.0001),表明疾病进展。在肾移植患者中,移植排斥反应伴有β2 - m血清水平升高。总之,数据清楚地表明了测量系统的可靠性以及β2 - M测定对于此类患者群体的临床相关性。