Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Clinical Chemistry |
| Vol/bind | 50 |
| Udgave nummer | 11 |
| Sider (fra-til) | 2141-7 |
| Antal sider | 6 |
| ISSN | 0009-9147 |
| DOI | |
| Status | Udgivet - 2004 |
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Detection of antinuclear antibodies by solid-phase immunoassays and immunofluorescence analysis. / Fenger, Mogens; Wiik, Allan; Høier-Madsen, Mimi; Lykkegaard, Jens J; Rozenfeld, Teresa; Hansen, Michael S; Samsoe, Bente Danneskjold; Jacobsen, Søren; Lykkegaard, Jens Jørgen; Rozenfeld, Teresa.
I: Clinical Chemistry, Bind 50, Nr. 11, 2004, s. 2141-7.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Detection of antinuclear antibodies by solid-phase immunoassays and immunofluorescence analysis
AU - Fenger, Mogens
AU - Wiik, Allan
AU - Høier-Madsen, Mimi
AU - Lykkegaard, Jens J
AU - Rozenfeld, Teresa
AU - Hansen, Michael S
AU - Samsoe, Bente Danneskjold
AU - Jacobsen, Søren
AU - Lykkegaard, Jens Jørgen
AU - Rozenfeld, Teresa
PY - 2004
Y1 - 2004
N2 - BACKGROUND: Antinuclear antibodies (ANAs) are associated with several inflammatory rheumatic diseases. The aim of the present work was to evaluate enzyme immunoassays (EIAs) and compare them with classic immunofluorescent analysis (IFA) for the detection of ANA. METHODS: Seven enzyme immunoassays were used in this study. All assays were applied as described by the manufacturers. Three populations were included in the study: (a) a population of patients with well-established autoimmune inflammatory disease (n = 102); (b) a population in which a rheumatic disease was diagnosed up to 5 years after an IFA was performed (n = 164); and (c) a population of consecutive outpatients suspected to have a rheumatic disease (n = 101). The current clinical diagnoses of the patients served as the standard against which performance of the assays was evaluated. RESULTS: In patients with well-established rheumatic disorders, the newly developed EIA in which HEp-2 extracts were included had sensitivities and specificities comparable to or in some instances better than the IFA. The assays without HEp-2 extracts included had significantly lower sensitivities and specificities. In the outpatient population, up to 51% of patients had positive ANA tests that did not correspond to classic ANA-associated disease. However, in the assays in which the HEp-2 extracts were not included, the false-positive rate was <10%. The false-negative rate judged against IFA differed from assay to assay and disease to disease and was mostly <10%. CONCLUSIONS: In this study, the sensitivities of EIAs and IFA were largely comparable. However, EIAs without HEp-2 extracts included had a low sensitivity but a high specificity, particularly in nonselected populations. The choice of test is highly dependent on the clinical setting in which the ANA test is to be used and on laboratory policy.
AB - BACKGROUND: Antinuclear antibodies (ANAs) are associated with several inflammatory rheumatic diseases. The aim of the present work was to evaluate enzyme immunoassays (EIAs) and compare them with classic immunofluorescent analysis (IFA) for the detection of ANA. METHODS: Seven enzyme immunoassays were used in this study. All assays were applied as described by the manufacturers. Three populations were included in the study: (a) a population of patients with well-established autoimmune inflammatory disease (n = 102); (b) a population in which a rheumatic disease was diagnosed up to 5 years after an IFA was performed (n = 164); and (c) a population of consecutive outpatients suspected to have a rheumatic disease (n = 101). The current clinical diagnoses of the patients served as the standard against which performance of the assays was evaluated. RESULTS: In patients with well-established rheumatic disorders, the newly developed EIA in which HEp-2 extracts were included had sensitivities and specificities comparable to or in some instances better than the IFA. The assays without HEp-2 extracts included had significantly lower sensitivities and specificities. In the outpatient population, up to 51% of patients had positive ANA tests that did not correspond to classic ANA-associated disease. However, in the assays in which the HEp-2 extracts were not included, the false-positive rate was <10%. The false-negative rate judged against IFA differed from assay to assay and disease to disease and was mostly <10%. CONCLUSIONS: In this study, the sensitivities of EIAs and IFA were largely comparable. However, EIAs without HEp-2 extracts included had a low sensitivity but a high specificity, particularly in nonselected populations. The choice of test is highly dependent on the clinical setting in which the ANA test is to be used and on laboratory policy.
U2 - http://dx.doi.org/10.1373/clinchem.2004.038422
DO - http://dx.doi.org/10.1373/clinchem.2004.038422
M3 - Journal article
VL - 50
SP - 2141
EP - 2147
JO - Clinical Chemistry
JF - Clinical Chemistry
SN - 0009-9147
IS - 11
ER -