The measurement of anti-double-stranded DNA (anti-dsDNA) antibodies is a useful tool for the diagnosis and the follow-up of systemic lupus erythematosus (SLE). Anti-dsDNA antibodies are involved in the pathogenesis of lupus nephritis and they are, specially the high-avidity antibodies, the most specific antibodies associated with SLE nephritis and active SLE. The aim of the present study was to assess the clinical utility of an enzyme-linked immunosorbent assay (EUSA) that utilizes a circular double-stranded plasmid DNA as a nucleic acid source, adapted to an automated fluorescence immunoassay (EliA dsDNA, Pharmacia, Freiburg, Germany). Also, we compared this method with other immunoassays used in clinical laboratories. We have measured anti-dsDNA antibodies in the serum of 179 patients with a positive result for antinuclear antibodies (ANA). Seventy six sera were from SLE patients (14 men and 62 women), and the other 103 sera (from 20 men and 83 women) constituted the control group. This latter group includes nine Sjogren's syndrome patients, six patients with rheumatoid arthritis and 88 with various other diseases, including connective tissue diseases (n=34), hepatopathies (n= 17; 11 primary biliary cirrhosis and 6 autoimmune hepatitis), and 37 patients with nonautoimmune diseases (viral hepatitis, renal disease, diabetes, exanthema and hypertension). Methods used were "EliA dsDNA" (Pharmacia, Germany), "Varelisa dsDNA" (Pharmacia, Germany), Farr (Amersham, UK) and Chritidia luciliae immunofluorescence test (Vitro-Immun, Germany). We assessed sensitivity, specificity, positive predictive value and negative predictive value in the clinical study, and kappa index and scatter plots in the comparative study. The results show a low concordance between methods (kappa < 0.6). The evaluated EliA method shows a very good specificity for SLE (93.2%) and a good sensitivity for active SLE (70.8%).
The biological variation of anti-TPO and anti-Tg autoantibodies was studied in 17 clinically and biochemically stable female patients with autoimmune thyroid disease (AITD), at regular monthly intervals over a period of 6 consecutive months. The mean and standard deviation (SD), within-subject coefficient of variation (CV), between-subject CV, index of individuality, reliability coefficient, and critical differences were as follows: for anti-TPO 238 (197) U/ml, 9.2%, 81.4%, 0.11, 0.96, and 27.6%; and for anti-Tg 1,785 (3,170) U/ml, 6.9%, 174%, 0.04, 0.99, and 22.3%. The data indicate a low within-subject CV, and a high between-subject CV that is particularly pronounced for anti-Tg. The high individuality of both autoantibodies indicates that an isolated result compared to conventional population-based reference intervals is of very little value for diagnosis. Furthermore, the near to 1 reliability coefficient for both autoantibodies correctly classifies the patient with respect to his or her homeostatic mean antibody concentration in a 6-month period of clinical and biochemical stability of thyroid disease. Imprecision goals for anti-TPO and anti-Tg antibodies are attainable with current methodology.
BackgroundThe retinal pathologies, main causes of blindness, produce a negative impact on patients’ vision-related quality of life (vrQoL).PurposeTo describe the baseline vrQoL in patients diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME) or branch/central retinal vein occlusion (B/CRVO).Material and methodsObservational, prospective study, from February 2014 to December 2016.Patients diagnosed with nAMD, DME or B/CRVO, who began with intravitreal ranibizumab and no treatment before, were included.The study was approved by the local Ethics Committee.The National Eye Institute Visual Function Questionnaire (NEIVFQ-25)1 was obtained by interviewer-administered format by previous informed consent for each patient.The NEIVFQ-25 is a 25-question instrument with 12 subscales: general health, general vision, near vision, distance vision, driving, peripheral vision, colour vision, ocular pain, role limitations, dependency, social function and mental health. The answer to each question is converted to a 100-point scale, where 0 represents the worst score and 100 the maximum. Items are averaged together to produce the scale score.Collected data were sex, age, retinal pathology, affected eye, baseline best-corrected visual acuity (BCVA), other ocular and systemic pathologies and glycated haemoglobin (HbA1c) level in diabetic patients.The statistical analysis was performed using SPSS versión 20.0.ResultsNinety-three patients were recruited (59% females, 41% males). The mean age was 74.1±11.1 years and the mean BCVA in the best eye was 0.8±0.7 logMAR.Baseline characteristics: Retinal pathology: nAMD 67% (63/93); DME 21.3% (20/93), BRVO 8 5% (8/93); CRVO 3.2% (3/93).Affected eye: right eye 43% (40/93), left eye 31.2% (29/93), bilateral 25.8% (24/93).Ocular pathologies: without cataract 48.4% (45/93); cataract without surgery 18.3% (17/93); with surgery (pseudoaphakia) 33.3% (31/93). glaucoma 7.5% (7/93), vitrectomy 3.2% (3/93).Systemic comorbidities: cardiovascular disease 31.2% (29/93); hypertension 66 7% (62/93), diabetes mellitus 32.3% (30/93); hypercholesterolaemia 14% (13/93); previous stroke 1.1% (1/93).Mean HbA1c: 7.9%±1.4.The baseline NEIVFQ-25 outcomes were:Overall composite score: 73.57±16.33.General health: 39.52±20.30.General vision: 56.88±15.03.Near vision: 63.80±22.61.Distance vision: 71.44±22.55.Driving: 68.18±39.55.Peripheral vision: 76.61±26.27.Colour vision: 94.23±13.98.Ocular pain: 78.09±24.98.Role limitations: 64.92±29.96.Dependency: 83.87±23.60.Social function: 85.05±20.27.Mental health: 66.33±21.43.ConclusionGeneral health, general vision, near vision, mental health and role limitations are several areas affected in patients with retinal pathologies, however, social function and dependency are the lowest affected.Reference and/or Acknowledgements1. Mangione CM. The National Eye Institute 25-Item Visual Function Questionnarie (NEIVFQ-25) scoring algorithm –August 2000.No conflict of interest
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