Do Labial Minor Salivary Gland Biopsies Maintain Diagnostic Sensitivity and Specificity for Sjögren's Disease - An Institutional Study.

Background: Current American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) guidelines indicate a positive biopsy with a score of ≥1 using focus scores (FS) to quantify lymphocytic foci presence. Accurate labial minor salivary gland biopsy (LMSGB) diagnosis depends on proper biopsy sampling, observer interpretation, and FS. There are fewer studies that evaluate the sensitivity and specificity of histology and serological testing. There was a substantial association between FS and the serological test, according to one study, but not in another. Aim: To determine the diagnostic sensitivity and specificity of LMSGB following the current ACR/EULAR diagnostic recommendations used for patients with suspected Sjögren's disease (SjD). Materials and Methods: Patients who had the symptoms of either dry mouth/eyes or both or suspected SjD with extraglandular symptoms and underwent minor salivary gland biopsies were included in this study. The study analyzed the variables of adequate amount of biopsy samples, focal scores, interpretations among pathologists with demographical data, and biochemical analysis for SjD diagnosis. Results: The positive predictive and negative predictive values were low, indicating limited effectiveness in predicting biopsy results. The overall accuracy was 40.54%, indicating ineffectiveness in distinguishing between those with and without the condition. Conclusion: The present study highlights the diagnostic limitations of minor salivary gland biopsy, indicating that a negative result does not rule out SjD but can rule out other infiltrative causes of xerostomia.