Guidelines for immunologic laboratory testing in the rheumatic diseases: Anti‐DNA antibody tests

Abstract

This paper is part of a series on immunologic testing guidelines. The series introduction (1) outlines the full methodology for obtaining data, grading the literature, combining the information from multiple sources, and developing recommendations. Briefly, MEDLINE and Healthstar were searched using a variety of search terms, and all relevant available literature was reviewed. All papers were critically reviewed using published standards for studies of diagnostic tests. Test use was categorized as primarily diagnostic or prognostic (which also included monitoring). Information was extracted from each paper to allow for calculation of a weighted average for sensitivity and specificity; likelihood ratios (LRs) were then derived from these values (positive LR ϭ sensitivity/[1 Ϫ specificity]; negative LR ϭ [1 Ϫ sensitivity]/specificity). Recommendations for use of tests were based on the LRs, where a test was considered to be "very useful" for a given disease if the weighted average positive LR was Ͼ5 or negative LR was Ͻ0.2. A test was considered "useful" if the weighted average positive LR was Ͼ2 and Յ5 or negative LR was Ͼ0.2 and Յ0.5. A test was considered "not useful" if the positive LR was Յ2 or the negative LR was Ͼ0.5.Antibodies capable of binding double-stranded DNA (dsDNA), single-stranded DNA (ssDNA), Z-DNA, and various other proteins associated with DNA (e.g., histones) can be detected in the serum of patients with systemic lupus erythematosus (SLE). In this analysis, the term anti-DNA antibody will refer only to antibodies specific for dsDNA (also referred to as native DNA). A number of studies have shown that antibodies to ssDNA (also referred to as denatured DNA) are less specific for the diagnosis of SLE than anti-dsDNA antibodies. While anti-ssDNA antibodies may be a useful research tool, they are an infrequently used clinical test, and will not be addressed further in this analysis.

Relationship between Anti-Ds-DNA Antibodies and Abnormal Kidney Function Tests in Patients with Lupus Nephritis

“…Detection of this type of antinuclear antibodies is highly suggestive of SLE disease, but a negative result of these antibodies in patient's specimen does not exclude the presence of such a disease (Habash-Bseiso et al, 2005). Possible occurrence of anti-dsDNA antibody in asymptomatic lupus patients should pay attention that this test should not be relied upon as a definite parameter to follow up disease activity (Kavanaugh and Solomon, 2002 Table 4 shows sensitivity and specificity of antidsDNA test in lupus nephritis patients using ELISA test. It was clearly demonstrated that sensitivity and specificity of the test were 74 and 100%, respectively.…”

Laboratory diagnosis of rheumatic diseases

“…Антитела к ДНК являются серологическим маркером СКВ. Антитела к дсДНК более специфич-ны для диагностики СКВ, чем антитела к осДНК, которые присутствуют в сыворотках больных при других РЗ и не имеют существенного диагностиче-ского значения (А) [4,12].…”

“…При поло-жительных результатах ИФА антител к дсДНК ре-комендуется проведение подтверждающих тестов, 6. Положительные результаты обнаружения ан-тител к дсДНК не позволяют достоверно прогнози-ровать обострения СКВ (А) [12].…”

“…При других РЗ тестирование антител к дсДНК бесполезно, так как они выявляются очень редко (≤5% случаев) и в низких титрах (А) [12].…”

Biomarkers and mediators in systemic lupus erythematosus : IFNα versus the CRP response, and evaluation of suPAR and anti-dsDNA antibody assays

“…These autoantibodies were later found to be valuable for the diagnosis of SLE as they are rarely found in sera of healthy controls or patients with other autoimmune diseases (apart from autoimmune hepatitis), but are found in many SLE patients at least sometime during their disease course [132,133]. However, the reported frequencies of anti-dsDNA positive SLE patients is highly varying and seems dependent on method of anti-dsDNA assessment and the disease severity of the patients [133].…”