Assay variation in the detection of antinuclear antibodies in the sera of patients with established SLE.

Abstract:

OBJECTIVE:The expression of antinuclear antibodies (ANA) is considered almost constant in systemic lupus erythematosus (SLE), although recent experience has suggested that many subjects with SLE considered for clinical trials are ANA negative at screening. The objective of this study is to determine whether assay variation can influence ANA detection in patients with established SLE. METHODS:Sera from 103 patients with established SLE were tested using three different immunofluorescence assays (IFA) for ANA determination. ANA determinations were also performed by an ELISA and bead-based multiplex assay. RESULTS:With IFA kits, the frequency of ANA negativity varied from 5 to 23 of 103 samples (4.9%-22.3%). The ELISA and multiplex assays showed that 12 (11.7%) and 14 (13.6%) samples were negative, respectively. Samples positive in all assays differed from those with discordant assay results in the frequency of historical anti-double-stranded DNA positivity and low complement levels at the time of blood sampling. DISCUSSION:These findings indicate that ANA negativity occurs in patients with established SLE although the frequency varies depending on the assay kit. Given the range of negativity with well-validated assays, these findings raise questions about whether ANA positivity should be employed to determine eligibility for clinical trials.

journal_name

Ann Rheum Dis

authors

Pisetsky DS,Spencer DM,Lipsky PE,Rovin BH

doi

10.1136/annrheumdis-2017-212599

subject

Has Abstract

pub_date

2018-06-01 00:00:00

pages

911-913

issue

6

eissn

0003-4967

issn

1468-2060

pii

annrheumdis-2017-212599

journal_volume

77

pub_type

杂志文章
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    doi:10.1136/ard.49.5.308

    authors: Castellanos J,Axelrod D

    更新日期:1990-05-01 00:00:00

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    journal_title:Annals of the rheumatic diseases

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    doi:10.1136/ard.47.5.359

    authors: Brown KA,McCarthy D,Perry JD,Dumonde DC

    更新日期:1988-05-01 00:00:00

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    doi:10.1136/ard.56.6.386

    authors: Batlle-Gualda E,Martínez AC,Guerra RA,Pascual E

    更新日期:1997-06-01 00:00:00

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    authors: Jacobi AM,Goldenberg DM,Hiepe F,Radbruch A,Burmester GR,Dörner T

    更新日期:2008-04-01 00:00:00

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    authors: Laragione T,Brenner M,Lahiri A,Gao E,Harris C,Gulko PS

    更新日期:2018-11-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1136/ard.34.6.529

    authors: Rebut-Bonneton C,Roucayrol JC,Delbarre F

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    doi:10.1136/ard.61.7.644

    authors: Baumgartner E,Finckh A,Cedraschi C,Vischer TL

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    pub_type: 杂志文章

    doi:10.1136/ard.2006.064741

    authors: Hammer HB,Odegard S,Fagerhol MK,Landewé R,van der Heijde D,Uhlig T,Mowinckel P,Kvien TK

    更新日期:2007-08-01 00:00:00

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    doi:10.1136/ard.2004.033688

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    doi:10.1136/ard.49.12.980

    authors: Hazes JM,Dijkmans BA,Vandenbroucke JP,de Vries RR,Cats A

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    doi:10.1136/ard.35.3.206

    authors: Roberts ME,Wright V,Hill AG,Mehra AC

    更新日期:1976-06-01 00:00:00

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    doi:10.1136/ard.48.12.998

    authors: Fry HJ,Rowley GL

    更新日期:1989-12-01 00:00:00

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    pub_type: 杂志文章,多中心研究

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    更新日期:2008-09-01 00:00:00

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    更新日期:1983-06-01 00:00:00

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