Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE
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 havin...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-12-01
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| Series: | Lupus Science and Medicine |
| Online Access: | https://lupus.bmj.com/content/6/1/e000349.full |
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| author | Daniel J Wallace Thierry Dervieux Arezou Khosroshahi Claudia Ibarra Tyler O'Malley Elena Massarotti Roberta Vezza Alexander Mehrnaz Hojjati Konstantinos Loupasakis Jeffrey Alper Yvonne Sherrer Maria Fondal Rajesh Kataria Tami Powell Sonali Narain Arthur Weinstein |
| author_facet | Daniel J Wallace Thierry Dervieux Arezou Khosroshahi Claudia Ibarra Tyler O'Malley Elena Massarotti Roberta Vezza Alexander Mehrnaz Hojjati Konstantinos Loupasakis Jeffrey Alper Yvonne Sherrer Maria Fondal Rajesh Kataria Tami Powell Sonali Narain Arthur Weinstein |
| author_sort | Daniel J Wallace |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e8603567b6e942a28008ffadbe58890d |
| institution | OA Journals |
| issn | 2053-8790 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Lupus Science and Medicine |
| spelling | doaj-art-e8603567b6e942a28008ffadbe58890d2025-08-20T01:56:45ZengBMJ Publishing GroupLupus Science and Medicine2053-87902019-12-016110.1136/lupus-2019-000349Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLEDaniel J Wallace0Thierry Dervieux1Arezou Khosroshahi2Claudia Ibarra3Tyler O'Malley4Elena Massarotti5Roberta Vezza Alexander6Mehrnaz Hojjati7Konstantinos Loupasakis8Jeffrey Alper9Yvonne Sherrer10Maria Fondal11Rajesh Kataria12Tami Powell13Sonali Narain14Arthur Weinstein155Cedars-Sinai Medical Center/University California at Los Angeles, Los AngelesExagen, Vista, Caifornia, USA7Emory University, Atlanta, United States of AmericaExagen, Vista, Caifornia, USAExagen, Vista, California, USA5Brigham and Women’s Hospital, Boston, MA, United States of AmericaExagen Inc, Vista, California, USALoma Linda University, Loma Linda, California, USA1MedStar Washington Hospital Center, Rheumatology, Washington, United States of AmericaBendcare, Naples, Florida, USABendcare, Naples, Florida, USABendcare, Naples, Florida, USASouthern Ohio Rheumatology, Wheelersburg, Ohio, USAExagen, Vista, Caifornia, USANorthwell Health, Great Neck, New York, USA5Georgetown University, Washington D.C., United States of AmericaObjective 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.https://lupus.bmj.com/content/6/1/e000349.full |
| spellingShingle | Daniel J Wallace Thierry Dervieux Arezou Khosroshahi Claudia Ibarra Tyler O'Malley Elena Massarotti Roberta Vezza Alexander Mehrnaz Hojjati Konstantinos Loupasakis Jeffrey Alper Yvonne Sherrer Maria Fondal Rajesh Kataria Tami Powell Sonali Narain Arthur Weinstein Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE Lupus Science and Medicine |
| title | Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE |
| title_full | Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE |
| title_fullStr | Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE |
| title_full_unstemmed | Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE |
| title_short | Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE |
| title_sort | randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of sle |
| url | https://lupus.bmj.com/content/6/1/e000349.full |
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