Choosing Wisely in Immunology Laboratory: Reviewing of Antinuclear Antibody (ANA) Test Requests and Results Together with Other Tests

Kemal Tekin, Hasan Karakuş, Sevinç Karabulut, F. Şahiner, R. Gümral
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Abstract

In this study, it was aimed to examine the distribution and positivity rates of the tests reported in the medical immunology laboratory of a tertiary education and research hospital, and to determine the distribution of antinuclear antibody (ANA) test requests, which constitute a significant part of the workload, according to disease diagnosis/preliminary diagnoses and clinical departments, and to examine the possible causes and costs of incorrect-inappropriate test orders, and to consider effective and applicable solution suggestions. In the study, a retrospective review of data on all immunoserology tests (n=94,954 individual parameters) reported approximately over a three-year period starting from September 2016 was presented. When the tests are divided into three main groups; among all test parameters, ANA tests ranked first with a rate of 20.3% (n=19,248). In our study, the positivity rate of ANA tests evaluated by the indirect immunofluorescence antibody (IFA) method was found as 23.1% (n=4,446). The number of reported parameters of specific autoantibody tests (second group), which include many different tests (IFA, ELISA, and immunoblot based), was 67,976, and the overall positivity was 2.96%, varies between 0.8% and 12.7%, depending on the antibody type. In the ELISA-based brucella and antiviral (herpes simplex virus 1 and 2, varicella virus, measles virus, mumps virus, parvovirus B19) IgM and IgG antibody tests in the third group, the highest positivity rate was observed according to the number of tests requested (30.1%, 2,324/7,730). In ANA-positive patients, the most frequently detected ANA-related autoantibodies were anti-dsDNA (9.2%) and anti-SS-A (8.2%). In ANA-negative patients, in simultaneously ordered tests, anti-dsDNA positivity was found to be 3.3%, while positivity rates for other ANA-related specific autoantibodies were in the range of 0.0-0.31%. ANA tests were most frequently ordered from the rheumatology department (34.2%), and also the highest ANA positivity rate (28%) was observed in this unit. The most notable reason for unnecessary test ordering was the test requests by different physicians for the same patient. We consider that evaluation of ANA tests at a dilution of 1:100 may lead to unnecessary second-step testing (specific autoantibodies) due to the low positive results, and that narrow-scope second-step autoantibody test panels will have negative effects on laboratory efficiency.
免疫学实验室中的明智选择:将抗核抗体 (ANA) 检测申请和结果与其他检测一起审核
本研究旨在考察一家三级教研医院医学免疫学实验室报告的检验项目的分布情况和阳性率,并根据疾病诊断/初步诊断和临床科室确定占工作量很大一部分的抗核抗体(ANA)检验申请的分布情况,考察错误-不适当检验单的可能原因和成本,并考虑有效和适用的解决建议。研究中,对自2016年9月起的三年内报告的所有免疫血清学检验数据(n=94954个单项参数)进行了回顾性回顾。如果将检测分为三大类,在所有检测参数中,ANA 检测以 20.3% 的比率(n=19248)位居第一。在我们的研究中,通过间接免疫荧光抗体(IFA)法评估的 ANA 检测阳性率为 23.1%(n=4 446)。特异性自身抗体检测(第二组)包括多种不同的检测方法(IFA、ELISA 和免疫印迹法),报告的参数数量为 67 976 个,总体阳性率为 2.96%,根据抗体类型的不同,阳性率在 0.8% 到 12.7% 之间。在第三组基于 ELISA 的布鲁氏菌和抗病毒(单纯疱疹病毒 1 和 2、水痘病毒、麻疹病毒、腮腺炎病毒、B19 副病毒)IgM 和 IgG 抗体检测中,根据申请检测的次数,阳性率最高(30.1%,2,324/7,730)。在 ANA 阳性患者中,最常检测到的 ANA 相关自身抗体是抗dsDNA(9.2%)和抗 SS-A(8.2%)。在 ANA 阴性患者中,在同时进行的检测中,抗dsDNA 阳性率为 3.3%,而其他 ANA 相关特异性自身抗体的阳性率在 0.0-0.31% 之间。风湿病科最常要求进行 ANA 检测(34.2%),该科室的 ANA 阳性率也最高(28%)。不必要的化验单最显著的原因是不同医生对同一患者提出的化验要求。我们认为,对稀释度为 1:100 的 ANA 检测进行评估可能会因阳性结果较低而导致不必要的第二步检测(特异性自身抗体),而且范围较窄的第二步自身抗体检测板将对实验室效率产生负面影响。
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