Ann Clin Biochem. 2011 Jan;48(Pt 1):65-71. doi: 10.1258/acb.2010.010197. Epub 2010 Nov 23.
Immunoassays are susceptible to analytical interferences including from endogenous immunoglobulin antibodies at a rate of ∼0.4% to 4%. Hundreds of millions of immunoassay tests (>10 millions in the UK alone) are performed yearly worldwide for measurements of an array of large and small moieties such as proteins, hormones, tumour markers, rheumatoid factor, troponin, small peptides, steroids and drugs.
Interference in these tests can lead to false results which when suspected, or surmised, can be analytically confirmed in most cases. Suspecting false laboratory data in the first place is not difficult when results are gross and without clinical correlates. However, when false results are subtle and/or plausible, it can be difficult to suspect with adverse clinical sequelae. This problem can be ameliorated by using a probabilistic Bayesian reasoning to flag up potentially suspect results even when laboratory data appear "not-unreasonable".
Essentially, in disorders with low prevalence, the majority of positive results caused by analytical interference are likely to be false positives. On the other hand, when the disease prevalence is high, false negative results increase and become more significant. To illustrate the scope and utility of this approach, six different examples covering wide range of analytes are given, each highlighting specific aspect/nature of interference and suggested options to reduce it.
Bayesian reasoning would allow laboratorians and/or clinicians to extract information about potentially false results, thus seeking follow-up confirmatory tests prior to the initiation of more expensive/invasive procedures or concluding a potentially wrong diagnosis.
免疫测定法容易受到分析干扰,包括内源性免疫球蛋白抗体的干扰,其发生率为 0.4%至 4%。全世界每年进行数亿次免疫测定试验(仅英国就超过 1000 万次),用于测量大量小分子,如蛋白质、激素、肿瘤标志物、类风湿因子、肌钙蛋白、小肽、类固醇和药物。
这些测试中的干扰会导致假结果,如果怀疑或推测有干扰,在大多数情况下可以进行分析确认。当结果明显且无临床相关性时,首先怀疑实验室数据有误并不难。然而,当假结果较细微且/或看似合理时,由于可能存在不良临床后果,因此难以怀疑。通过使用概率贝叶斯推理,可以即使在实验室数据“看似合理”的情况下,也可以标记出可能存在问题的结果,从而改善这一问题。
本质上,在患病率较低的疾病中,大多数由分析干扰引起的阳性结果可能是假阳性。另一方面,当疾病的患病率较高时,假阴性结果会增加,并且变得更加显著。为了说明这种方法的范围和实用性,给出了六个涵盖广泛分析物的不同示例,每个示例都突出了干扰的特定方面/性质,并提出了减少干扰的建议。
贝叶斯推理可以让实验室技术人员和/或临床医生提取关于潜在假结果的信息,从而在进行更昂贵/侵入性的程序或得出潜在错误的诊断之前,寻求后续的确认性测试。