申请人:BOEHRINGER MANNHEIM CORPORATION
公开号:EP0918220A1
公开(公告)日:1999-05-26
Diazonium ions which are useful as reagents for the assay of bilirubin content in a sample, such as a body fluid sample, are provided. In one preferred embodiment, 2-methyl-3-nitroaniline diazonium ion is provided, having the structure:
Also provided are reagent compositions including the diazonium ions. The reagent compositions may be in liquid or solid form, and further may include other components, such as buffers, carriers, and solubilizers. Salts including the diazonium ion and a counteranion also are provided. Also provided are methods of using the diazonium ions in assays to detect or quantitate bilirubin present in a sample such as a body fluid sample. Using the assays, the amount of direct, indirect, and total bilirubin in a sample may be accurately and reproducibly detected, and optionally correlated with the presence or absence of any of a variety of diseases or disorders of organs such as the liver, gall bladder or intestines. Using the assays, a wide range of different body fluid samples, such as urine, plasma or serum samples may be tested, and the interference in the assay from other components of the sample may be minimized.
本发明提供了可用作检测样品(如体液样品)中胆红素含量试剂的重氮离子。在一个优选的实施方案中,提供了具有上述结构的 2-甲基-3-硝基苯胺重氮离子:
还提供了包括重氮离子的试剂组合物。试剂组合物可以是液体或固体形式,还可以包括其他成分,如缓冲剂、载体和增溶剂。还提供了包括重氮离子和反阴离子的盐。此外,还提供了在化验中使用重氮离子检测或定量存在于体液样本等样品中的胆红素的方法。使用这些检测方法,可以准确、可重复地检测样品中的直接胆红素、间接胆红素和总胆红素的含量,并将其与是否存在肝脏、胆囊或肠道等器官的各种疾病或失调中的任何一种联系起来。使用这种检测方法,可以检测多种不同的体液样本,如尿液、血浆或血清样本,而且可以最大限度地减少样本中其他成分对检测的干扰。