重复抗核抗体检测的效用：一项回顾性数据库研究。

Utility of repeated antinuclear antibody tests: a retrospective database study.

作者信息

Yeo Ai Li, Le Suong, Ong Jason, Connelly Kathryn, Ojaimi Samar, Nim Hieu, Morand Eric F, Leech Michelle

机构信息

Centre for Inflammatory Diseases, Monash University, Clayton, VIC, Australia; Department of Rheumatology, Monash Health, Clayton, VIC, Australia.

Centre for Inflammatory Diseases, Monash University, Clayton, VIC, Australia.

出版信息

Lancet Rheumatol. 2020 Jul;2(7):e412-e417. doi: 10.1016/S2665-9913(20)30084-9. Epub 2020 May 20.

DOI:10.1016/S2665-9913(20)30084-9

PMID:38273605

Abstract

BACKGROUND

Anti-nuclear antibody (ANA) testing is frequently used as a diagnostic or screening test in patients with inflammatory or musculoskeletal symptoms. The value of repeat testing is unclear. We sought to evaluate the frequency, utility, and cost of repeat ANA testing. The main objective was to assess the positive predictive value of a repeat ANA test for the diagnosis of rheumatological conditions associated with ANA.

METHODS

In this retrospective cohort study, we analysed data from a single, multisite tertiary health network in Australia across a 7-year period. ANA and other autoimmune test results were obtained from the hospital pathology system with a positive ANA titre cutoff set at 1:160. Clinical information was sourced from clinical information systems on any patient who had a change in ANA result from negative to positive on repeat testing. The cost of repeated ANA testing was calculated using the Australian Government Medicare Benefits Schedule.

FINDINGS

From March 19, 2011, to July 23, 2018, a total of 36 715 ANA tests were done in 28 840 patients at a total cost of US$675 029 (2018 equivalent). 14 058 (38·3%) of these ANA tests were positive. 7875 (21·4%) of the ordered tests were repeats in 4887 (16·9%) of the patients, among whom 2683 (54·9%) had initially negative tests, and 2204 (45·1%) had initially positive tests. 511 (19·0%) of the 2683 patients with initially negative tests had a positive result on at least one repeat test, with a median time to first positive result of 1·74 years (IQR 0·54-3·60). A change from negative to positive ANA was associated with a new diagnosis in only five (1·1%) of the 451 patients with clinical information available and no previous diagnosis of an ANA-associated rheumatological condition, yielding a positive predictive value of 1·1% (95% CI 0·4-2·7).

INTERPRETATION

Repeat ANA testing after a negative result has low utility and results in high cost.

FUNDING

Monash Health.

摘要

背景

抗核抗体（ANA）检测常用于有炎症或肌肉骨骼症状患者的诊断或筛查。重复检测的价值尚不清楚。我们旨在评估重复ANA检测的频率、效用及成本。主要目的是评估重复ANA检测对诊断与ANA相关的风湿性疾病的阳性预测值。

方法

在这项回顾性队列研究中，我们分析了澳大利亚一个单一的多中心三级医疗网络7年间的数据。ANA及其他自身免疫检测结果来自医院病理系统，ANA滴度阳性临界值设定为1:160。临床信息来自临床信息系统，针对重复检测ANA结果由阴性转为阳性的任何患者。重复ANA检测的成本根据澳大利亚政府医疗保险福利计划计算。

结果

从2011年3月19日至2018年7月23日，28840例患者共进行了36715次ANA检测，总成本为675029美元（按2018年等价物计算）。其中14058次（38.3%）ANA检测呈阳性。所开检测中有7875次（21.4%）为重复检测，涉及4887例（16.9%）患者，其中2683例（54.9%）最初检测为阴性，2204例（45.1%）最初检测为阳性。2683例最初检测为阴性的患者中，511例（19.0%）至少有一次重复检测呈阳性，首次阳性结果的中位时间为1.74年（IQR 0.54 - 3.60）。在451例有临床信息且既往未诊断为ANA相关风湿性疾病的患者中，ANA从阴性转为阳性仅与5例（1.1%）新诊断相关，阳性预测值为1.1%（95% CI 0.4 - 2.7）。