Ismail Adel A A, Walker Paul L, Barth Julian H, Lewandowski Kryzsztof C, Jones Rick, Burr William A
Department of Clinical Biochemistry, at Pinderfields General Hospital, Mid Yorkshire Hospitals NHS Trust, Wakefield, West Yorkshire WF1 4DG, United Kingdom.
Clin Chem. 2002 Nov;48(11):2023-9.
Immunoassays are used in almost all medical and surgical specialties, but they suffer from interference from proteins such as antibodies in some patients' sera. Such interferences are usually reported in the literature only as case reports after the introduction of a new assay.
We undertook a prospective observational study on 5310 patients for whom the common immunoassay tests for thyroid-stimulating hormone (TSH) and/or gonadotropins were requested. All TSH and gonadotropin results were critically assessed for a mismatch between the clinical details and analytical results to identify samples suspected of analytical unreliability. These were tested further by three approaches to screen for interference.
From the 5310 sets of results, 59 patients' samples were identified as suspect and were tested further. Analytically incorrect results were found in 28 (0.53% of the total studied). The magnitude of interference varied, but in 23 of 28 patients (82%), it was considered large enough to have a potentially adverse effect on cost and/or the clinical care of these patients. Two cases, described in detail, illustrate the adverse effect of error on patient care and cost, and the second highlights the difficulties and limitations of current approaches for identifying interference and inaccuracy in immunoassays.
Because millions of TSH/gonadotropin tests are carried out in UK hospital laboratories alone, our data suggest that thousands of patients could be adversely affected by errors from interferences. Early identification of interference in cases with unusual results could be valuable.
免疫测定几乎应用于所有医学和外科专业领域，但在一些患者血清中，它们会受到诸如抗体等蛋白质的干扰。此类干扰在文献中通常仅在新检测方法引入后作为病例报告出现。
我们对5310例被要求进行促甲状腺激素（TSH）和/或促性腺激素常规免疫测定的患者进行了一项前瞻性观察研究。对所有TSH和促性腺激素检测结果进行严格评估，以确定临床细节与分析结果之间是否存在不匹配，从而识别疑似分析不可靠的样本。通过三种方法对这些样本进行进一步检测以筛查干扰。
从5310组结果中，识别出59例患者的样本为可疑样本并进行了进一步检测。发现28例（占总研究数的0.53%）分析结果不正确。干扰程度各不相同，但在28例患者中的23例（82%）中，干扰程度被认为足以对这些患者的费用和/或临床护理产生潜在不利影响。详细描述的两个病例说明了检测错误对患者护理和费用的不利影响，第二个病例突出了当前识别免疫测定中干扰和不准确的方法的困难和局限性。
仅在英国医院实验室就进行了数百万次TSH/促性腺激素检测，我们的数据表明，数千名患者可能会受到干扰导致的错误的不利影响。早期识别结果异常病例中的干扰可能很有价值。
