Binder Steven R, Genovese Mark C, Merrill Joan T, Morris Robert I, Metzger Allan L
Bio-Rad Laboratories, 4000 Alfred Nobel Drive, Hercules, CA 94547, USA.
Clin Diagn Lab Immunol. 2005 Dec;12(12):1353-7. doi: 10.1128/CDLI.12.12.1353-1357.2005.
Immunoassay-based anti-nuclear antibody (ANA) screens are increasingly used in the initial evaluation of autoimmune disorders, but these tests offer no "pattern information" comparable to the information from indirect fluorescence assay-based screens. Thus, there is no indication of "next steps" when a positive result is obtained. To improve the utility of immunoassay-based ANA screening, we evaluated a new method that combines a multiplex immunoassay with a k nearest neighbor (kNN) algorithm for computer-assisted pattern recognition. We assembled a training set, consisting of 1,152 sera from patients with various rheumatic diseases and non-diseased patients. The clinical sensitivity and specificity of the multiplex method and algorithm were evaluated with a test set that consisted of 173 sera collected at a rheumatology clinic from patients diagnosed by using standard criteria, as well as 152 age- and sex-matched sera from presumably healthy individuals (sera collected at a blood bank). The test set was also evaluated with a HEp-2 cell-based enzyme-linked immunosorbent assay (ELISA). Both the ELISA and multiplex immunoassay results were positive for 94% of the systemic lupus erythematosus (SLE) patients. The kNN algorithm correctly proposed an SLE pattern for 84% of the antibody-positive SLE patients. For patients with no connective tissue disease, the multiplex method found fewer positive results than the ELISA screen, and no disease was proposed by the kNN algorithm for most of these patients. In conclusion, the automated algorithm could identify SLE patterns and may be useful in the identification of patients who would benefit from early referral to a specialist, as well as patients who do not require further evaluation.
基于免疫测定的抗核抗体(ANA)筛查越来越多地用于自身免疫性疾病的初步评估,但这些检测无法提供与基于间接荧光测定的筛查所获信息相当的“模式信息”。因此,当获得阳性结果时,没有“下一步措施”的指示。为提高基于免疫测定的ANA筛查的效用,我们评估了一种将多重免疫测定与k最近邻(kNN)算法相结合以进行计算机辅助模式识别的新方法。我们组建了一个训练集,其中包括来自各种风湿性疾病患者和非患病患者的1152份血清。使用一个测试集评估多重方法和算法的临床敏感性和特异性,该测试集包括在一家风湿病诊所收集的173份血清,这些血清来自根据标准标准诊断的患者,以及152份来自推测健康个体(在血库收集的血清)的年龄和性别匹配的血清。该测试集也使用基于人喉癌上皮细胞(HEp-2)的酶联免疫吸附测定(ELISA)进行评估。ELISA和多重免疫测定结果对94%的系统性红斑狼疮(SLE)患者均呈阳性。kNN算法为84%的抗体阳性SLE患者正确提出了SLE模式。对于无结缔组织病的患者,多重方法发现的阳性结果比ELISA筛查少,并且kNN算法对这些患者中的大多数未提出患有疾病。总之,这种自动化算法可以识别SLE模式,可能有助于识别那些将从早期转诊至专科医生中受益的患者,以及那些不需要进一步评估的患者。