TY  - BOOK
AU  - Loupasakis, Konstantinos
TI  - Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE
SN  - 2053-8790
PY  - 2019///
KW  - IN PROCESS -- NOT YET INDEXED
KW  - MedStar Washington Hospital Center
KW  - Medicine/Rheumatology
KW  - Journal Article
N2  - Conclusion: Our data suggest that MAP/CB-CAPs testing has clinical utility in facilitating SLE diagnosis and treatment decisions. Copyright (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ; Methods: Patients (n=145) with a history of positive antinuclear antibody status were evaluated clinically by rheumatologists and randomised to SDLT arm (tests ordered at the discretion of the rheumatologists) or to MAP/CB-CAPs testing arm. The primary endpoint was based on the change in the physician likelihood of SLE on a five-point Likert scale collected before and after testing. Changes in pharmacological treatment based on laboratory results were assessed in both arms. Statistical analysis consisted of Wilcoxon and Fisher's exact tests; Objective: We compared the physician-assessed diagnostic likelihood of SLE resulting from standard diagnosis laboratory testing (SDLT) to that resulting from multianalyte assay panel (MAP) with cell-bound complement activation products (MAP/CB-CAPs), which reports a two-tiered index test result having 80% sensitivity and 86% specificity for SLE; Results: At enrolment, patients randomised to SDLT (n=73, age=48+/-2 years, 94% females) and MAP/CB-CAPs testing arms (n=72, 50+/-2 years, 93% females) presented with similar pretest likelihood of SLE (1.42+/-0.06 vs 1.46+/-0.06 points, respectively; p=0.68). Post-test likelihood of SLE resulting from randomisation in the MAP/CB-CAPs testing arm was significantly lower than that resulting from randomisation to SDLT arm on review of test results (-0.44+/-0.10 points vs -0.19+/-0.07 points) and at the 12-week follow-up visit (-0.61+/-0.10 points vs -0.31+/-0.10 points) (p<0.05). Among patients randomised to the MAP/CB-CAPs testing arm, two-tiered positive test results associated significantly with initiation of prednisone (p=0.034)
UR  - https://dx.doi.org/10.1136/lupus-2019-000349
ER  -