Diagnostic performance of a commercial immunoblot assay for myositis antibody testing.

Abstract:

:The objective of this study was to establish a population based reference range for a commercial immunoblot assay detecting myositis specific autoantibodies (MSAs) and myositis associated autoantibodies (MAAs), and to assess the diagnostic performance of this reference range against the manufacturer's recommended ranges in a myositis patient cohort. A total of 124 patients from a myositis cohort and 197 healthy controls were serologically assessed using a commercial immunoblot containing eleven autoantigens (Jo-1, EJ, OJ, PL7, PL12, Mi-2, SRP, Ku, PMScl75, PMScl100 and Ro52) according to the manufacturer's instructions. Use of the manufacturer's reference ranges resulted in detection of MSAs in 19.4% of myositis patients and 9.1% of controls; MAAs were detected in 41.1% of myositis patients and 14.2% of controls. Reference values derived from the healthy control population resulted in significant differences in cut-off values for some autoantibodies, particularly Ro52 and PMScl75. Use of local reference ranges reduced detection of MSAs to 16.9% of myositis patients and 3% of healthy controls, with MAAs 23.4% of patients and 2% of healthy controls. Application of population based reference ranges resulted in significant differences in detection of MSAs and MAAs compared to the manufacturer's recommended ranges. Cut-off levels should be assessed to ensure suitability for the population tested.

journal_name

Pathology

journal_title

Pathology

authors

Bundell C,Rojana-Udomsart A,Mastaglia F,Hollingsworth P,McLean-Tooke A

doi

10.1016/j.pathol.2016.03.012

subject

Has Abstract

pub_date

2016-06-01 00:00:00

pages

363-6

issue

4

eissn

0031-3025

issn

1465-3931

pii

S0031-3025(16)40084-X

journal_volume

48

pub_type

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