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The universe of ANA testing: a case for point-of-care ANA testing

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      Abstract

      Testing for total antinuclear antibodies (ANA) is a critical tool for diagnosis and management of autoimmune diseases at both the primary care and subspecialty settings. Repurposing of ANA from a test for lupus to a test for any autoimmune condition has driven the increase in ANA requests. Changes in ANA referral patterns include early or subclinical autoimmune disease detection in patients with low pre-test probability and use of negative ANA results to rule out underlying autoimmune disease. A positive result can lead to further diagnostic considerations. Currently, ANA tests are performed in centralized laboratories; an alternative would be ANA testing at the clinical point-of-care (POC). By virtue of its near real-time data collection capability, low cost, and ease of use, we believe the POC ANA has the potential to enable a new paradigm shift in autoimmune serology testing.

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      International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies.

      Anti-nuclear antibodies (ANA) are fundamental for the diagnosis of autoimmune diseases, and have been determined by indirect immunofluorescence assay (IIFA) for decades. As the demand for ANA testing increased, alternative techniques were developed challenging the classic IIFA. These alternative platforms differ in their antigen profiles, sensitivity and specificity, raising uncertainties regarding standardisation and interpretation of incongruent results. Therefore, an international group of experts has created recommendations for ANA testing by different methods. Two groups of experts participated in this initiative. The European autoimmunity standardization initiative representing 15 European countries and the International Union of Immunologic Societies/World Health Organization/Arthritis Foundation/Centers for Disease Control and Prevention autoantibody standardising committee. A three-step process followed by a Delphi exercise with closed voting was applied. Twenty-five recommendations for determining ANA (1-13), anti-double stranded DNA antibodies (14-18), specific antibodies (19-23) and validation of methods (24-25) were created. Significant differences between experts were observed regarding recommendations 24-25 (p<0.03). Here, we formulated recommendations for the assessment and interpretation of ANA and associated antibodies. Notably, the roles of IIFA as a reference method, and the importance of defining nuclear and cytoplasmic staining, were emphasised, while the need to incorporate alternative automated methods was acknowledged. Various approaches to overcome discrepancies between methods were suggested of which an improved bench-to-bedside communication is of the utmost importance. These recommendations are based on current knowledge and can enable harmonisation of local algorithms for testing and evaluation of ANA and related autoantibodies. Last but not least, new more appropriate terminologies have been suggested.
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        Primary care physician specialty referral decision making: patient, physician, and health care system determinants.

        To examine the effects of patient, physician, and health care system characteristics on primary care physicians' (PCPs') specialty referral decision making. Physicians (n=142) and their practices (n=83) located in 30 states completed background questionnaires and collected survey data for all patient visits (n=34,069) made during 15 consecutive workdays. The authors modeled the occurrence of any specialty referral, which occurred during 5.2% of visits, as a function of patient, physician, and health care system structural characteristics. A subanalysis was done to examine determinants of referrals made for discretionary indications (17% of referrals), operationalized as problems commonly managed by PCPs, high level of diagnostic and therapeutic certainty, low urgency for specialist involvement, and cognitive assistance only requested from the specialist. Patient characteristics had the largest effects in the any-referral model. Other variables associated with an increased risk of referral included PCPs with less tolerance of uncertainty, larger practice size, health plans with gate-keeping arrangements, and practices with high levels of managed care. The risk of a referral being made for discretionary reasons was increased by capitated primary care payment, internal medicine specialty of the PCP, high concentration of specialists in the community, and higher levels of managed care in the practice. PCPs' referral decisions are influenced by a complex mix of patient, physician, and health care system structural characteristics. Factors associated with more discretionary referrals may lower PCPs' thresholds for referring problems that could have been managed in their entirety within primary care settings.
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          "I wish I had seen this test result earlier!": Dissatisfaction with test result management systems in primary care.

          Failure to review and follow up on outpatient test results in a timely manner represents a patient safety and malpractice concern. Therefore, we sought to identify problems in current test result management systems and possible ways to improve these systems. We surveyed 262 physicians working in 15 internal medicine practices affiliated with 2 large urban teaching hospitals (response rate, 64%). We asked physicians about systems they used and the amount of time they spent managing test results. We asked them to report delays in reviewing test results and their overall satisfaction with their management of test results. We also asked physicians to rate features they would find useful in a new test result management system. Overall, 83% of respondents reported at least 1 delay in reviewing test results during the previous 2 months. Despite reporting that they spent on average 74 minutes per clinical day managing test results, only 41% of physicians reported being satisfied with how they managed test results. Satisfaction was associated with fewer self-reported delays in reviewing test results. Physicians who actively tracked their test orders to completion were also more likely to be satisfied. The most highly desired features of a test result management system were tools to help physicians generate result letters to patients, prioritize their workflow, and track test orders to completion. Delays in test result review are common, and many physicians are not satisfied with how they manage test results. Tools to improve test result management in office practices need to improve workflow efficiency and track test orders to completion.
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            Author and article information

            Affiliations
            [1 ]ISNI 0000 0001 2188 8502, GRID grid.266832.b, Division of Rheumatology/Department of Internal Medicine, , University of New Mexico Health Sciences Center, 1 University of New Mexico, ; Mail Stop MSC10-5550, Albuquerque, NM 87131 USA
            [2 ]ISNI 0000 0000 9831 362X, GRID grid.413580.b, Rheumatology Section, , Raymond G. Murphy VA Medical Center, ; 1501 San Pedro SE, Albuquerque, NM 87108 USA
            [3 ]ISNI 0000 0001 2188 8502, GRID grid.266832.b, Department of Molecular Genetics and Microbiology, , University of New Mexico Health Sciences Center, 1 University of New Mexico, ; Albuquerque, NM 87131 USA
            Contributors
            kkonstantinov@salud.unm.edu
            rlrubin@salud.unm.edu
            Journal
            Auto Immun Highlights
            Auto Immun Highlights
            Auto-Immunity Highlights
            Springer International Publishing (Cham )
            2038-0305
            2038-3274
            21 March 2017
            21 March 2017
            December 2017
            : 8
            : 1
            28324325
            5360668
            93
            10.1007/s13317-017-0093-6
            © The Author(s) 2017

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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            Review Article
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            © The Author(s) 2017

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