CELL-BOUND COMPLEMENT ACTIVATION PRODUCTS AS DIAGNOSTIC BIOMARKERS FOR PRE-LUPUS

摘要

Cell-bound complement activation product (CB-CAP) profiling and scoring serve as diagnostic biomarkers for patients to determine whether a patient who has not met at least four American College of Rheumatology (or similar e.g. SLICC) criteria for a definite Lupus diagnosis should be classified as exhibiting a pre-existing condition that this document refers to as pre-Lupus. This document also describes methods for determining whether a patient who has been determined to exhibit pre-Lupus has progressed to exhibiting definite Lupus.

主权项

1. A method of determining whether to classify a patient as exhibiting pre-Lupus, comprising:
receiving a blood sample for a patient who is determined to meet fewer than four classification criteria for Lupus; performing a panel of cell-bound complement activation product (CB-CAP) assays on the blood sample to generate a set of blood sampling data for the patient, wherein the set of blood sampling data comprises levels of at least two the following CB-CAPs for the patient: E-C4d, R-C4d, P-C4d, T-C4d, B-C4d, M-C4d, or G-C4d; comparing the CB-CAP levels for the patient with a set of control levels to determine a number of the CB-CAPs for which the patient's CB-CAP levels are elevated as compared to the control levels; generating a score based upon the number of the CB-CAPs for which the patient's CB-CAP levels exceed a threshold; determining whether the score is greater than an average score for other patients; and if the score is determined to be greater than an average score for the other patients, classifying the patient as not having Lupus but exhibiting an increased risk of developing Lupus, otherwise classifying the patient as neither having Lupus nor having the increased risk of developing Lupus.