Sinclair David, Saas Myk, Williams Diane, Hart Melanie, Goswami Rajee
Department of Clinical Biochemistry, Queen Alexandra Hospital, Portsmouth, UK.
Clin Lab. 2007;53(3-4):183-91.
The aim of this study was to evaluate a commercially available ELISA assay for anti-nuclear antibodies (ANA) screening in a large routine laboratory setting. The detection of ANA is a commonly requested test by clinicians for patients suspected of rheumatic disease and other connective tissue diseases. Detection is part of the diagnostic criteria of rheumatic diseases such as SLE and can be important for monitoring purposes. ANA screening assays are typically indirect immunofluorescence (IIF), either on rodent tissue or HEp-2 cells; however, these are slow, subjective and laborious. In this study, in a routine serology laboratory setting, 2000 consecutive sera with requests for an ANA screen were tested by ELISA and results compared to those obtained by immunofluorescence. From these results we established an ANA ratio cut-off protocol to guide further action, a second series of 7000 samples was studied to assess the efficacy of this. Results show that the ANA ELISA can successfully replace IIF for the detection of clinically significant antibodies.
本研究的目的是在大型常规实验室环境中评估一种用于抗核抗体（ANA）筛查的市售酶联免疫吸附测定（ELISA）。ANA检测是临床医生对疑似患有风湿性疾病和其他结缔组织疾病的患者常用的检测项目。ANA检测是系统性红斑狼疮等风湿性疾病诊断标准的一部分，对于监测病情也很重要。ANA筛查检测通常采用间接免疫荧光法（IIF），检测对象为啮齿动物组织或人喉表皮癌细胞（HEp-2细胞）；然而，这些方法耗时、主观且费力。在本研究中，在常规血清学实验室环境下，对2000份连续送检要求进行ANA筛查的血清样本采用ELISA法进行检测，并将结果与免疫荧光法的检测结果进行比较。根据这些结果，我们制定了一个ANA比值临界值方案以指导后续操作，并对另外7000份样本进行了研究，以评估该方案的有效性。结果表明，ANA ELISA能够成功替代IIF用于检测具有临床意义的抗体。
