TY - JOUR T1 - Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE JF - Lupus Science & Medicine JO - Lupus Sci Med Lupus Sci Med DO - 10.1136/lupus-2019-000349 VL - 6 IS - 1 SP - e000349 AU - Daniel J Wallace AU - Roberta Vezza Alexander AU - Tyler O'Malley AU - Arezou Khosroshahi AU - Mehrnaz Hojjati AU - Konstantinos Loupasakis AU - Jeffrey Alper AU - Yvonne Sherrer AU - Maria Fondal AU - Rajesh Kataria AU - Tami Powell AU - Claudia Ibarra AU - Sonali Narain AU - Elena Massarotti AU - Arthur Weinstein AU - Thierry Dervieux Y1 - 2019/09/01 UR - http://lupus.bmj.com/content/6/1/e000349.abstract N2 - 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.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.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).Conclusion Our data suggest that MAP/CB-CAPs testing has clinical utility in facilitating SLE diagnosis and treatment decisions. ER -