Noninvasive Score in Classification Diagnosis of Sjögren's Syndrome

Jinquan Yu

doi:10.2174/1874312901913010039

Abstract

Background: To develop simple, practical classification criteria for Sjögren's Syndrome (SS) without Labial Salivary Gland Biopsy (LSGB). Methods: In the new criteria (noninvasive score, NIS) set, classification as “definite SS” is based on the ocular and oral symptoms and signs, autoantibodies and the existence of autoimmune thyroid disease, which were calculated. Patients with a score ≥5 were classified as having definite SS and patients with a score <4 were supposed to be excluded from SS. For the patients with a score of 4, LSGB was suggested. Result: 76 patients with suspected SS were recruited between April 2013 and September 2014, 42 of which were definitive diagnosis of SS and 34 were excluded from SS. Sensitivity and specificity for the NIS criteria in the diagnosis of SS were 97.6% and 94.1%, respectively. The Negative Predictive Value (NPV) and Positive Predictive Value (PPV) to detect SS were 97.0% and 95.3% respectively, and the diagnostic accuracy was 96.1%. The area under the ROC curves (AUC; 95% CI) for NIS criteria was 0.959 (0.905-1.000), which performed better than the American-European Consensus Group’s (AECG) criteria and LSGB in the diagnosis of SS (P < 0.05). Conclusion: The NIS criteria are an alternative to the AECG criteria in classification diagnosis of SS, which are with high diagnostic efficiency. We recommend using a score <4 and ≥5 to rule out or to diagnose SS respectively. For the patients with a score of 4, LSGB is necessary and able to diagnose SS.

Highlights

Sjögren's Syndrome (SS) is a systemic chronic inflammatory disease characterized by lymphocytic infiltrates in exocrine organs
The NIS criteria are an alternative to the American-European Consensus Group (AECG) criteria in classification diagnosis of SS, which are with high diagnostic efficiency
The American-European Consensus Group’s (AECG) criteria for the classification of SS were proposed in 2002 and were the most commonly used criteria for the diagnosis of SS in the past, which were with high sensitivity of 97.2% but low specificity of 48.6% in the diagnosis of primary SS (PSS), and with high specificity of 97.2% but low sensitivity of 64.7% in the diagnosis of secondary SS (SSS) [3 - 5]

Summary

Introduction

Sjögren's Syndrome (SS) is a systemic chronic inflammatory disease characterized by lymphocytic infiltrates in exocrine organs. There are many other diseases that can cause sicca symptoms [2], and there are no specific examinations for SS, for example the lack of specific autoantibodies and even Labial Salivary Gland Biopsy (LSGB) cannot be used as a single gold standard. A new set of classification criteria has been developed by the Sjögren's Syndrome International Collaborative Clinical Alliance (SICCA) and accepted as a provisional criteria set by the American College of Rheumatology (ACR) in 2012 in order to improve the efficiency of diagnosis. Practical classification criteria for Sjögren's Syndrome (SS) without Labial Salivary Gland Biopsy (LSGB)

Results

Discussion

Conclusion