Abstract Background/Aims To assess the diagnostic utility of major salivary gland ultrasonography (SGUS) in patients with clinically suspected Sjögren’s disease by correlating findings with MSGB results. Methods 52 patients suspected to have Sjögren’s disease by physician and who were negative for anti SSA and SSB were included in the study. All patients underwent major salivary gland ultrasonography scored using both the OMERACT and Hocevar systems, alongside evaluation for sicca features (Schirmer’s test, unstimulated salivary flow rate), and MSGB. Demographic, clinical, and laboratory data were collected and analyzed for correlation with SGUS and biopsy results, focus score ≥1 was considered positive for Sjogrens. Statistical analysis included correlation coefficients, logistic regression, and comparison of diagnostic metrics such as sensitivity, specificity, and predictive values. Results A total of 52 patients with clinically suspected primary Sjögren’s disease were included in the study. Of these, 16 patients had MSGB positivity qualifying them to be seronegative Sjögren’s disease. The mean age of 16 seronegative SjD was 48.43 ±9.90 years and all were females. Only 25 % of patients reported sicca symptoms at presentation, but over the course of disease, 62.5 % developed sicca symptoms & objective evidence of sicca. Schirmer was positive in 68.75 % and unstimulated salivary flow rate (USFR) was reduced in 62.5 %. Chronic pain and fatigue were the predominant symptoms (93.75%), while musculoskeletal complaints and sicca symptoms were reported in 62.5 % of patients each. The OMERACT ultrasonography score demonstrated high sensitivity (81.2%) but low specificity (8.3%), a modest positive predictive value (PPV) of 28.3% and NPV of 50 %. In contrast, the Hocevar score exhibited high specificity (86.1%) and a better negative predictive value (NPV) of 67.4%, but very low sensitivity (6.2%) and PPV (16.7%). Neither SGUS score showed a statistically significant association with MSGB positivity. No significant correlation was observed between either SGUS score and Schirmer’s test, ocular staining score (OSS), USFR, ESSDAI, or subjective symptom scores (ESSPRI). A borderline association was found between USFW and biopsy positivity (OR = 3.61, p = 0.05), indicating its potential as a non-invasive functional marker in seronegative patients. These findings indicate that salivary gland ultrasonography (SGUS) has limited diagnostic utility in the seronegative population. Minor salivary gland biopsy (MSGB) continues to be the gold standard for diagnosis in this subgroup. Conclusion This study highlights the limited utility of major salivary gland ultrasonography (SGUS) in diagnosing seronegative primary Sjögren’s disease (SjD). SGUS findings poorly correlated with histopathology and functional tests, emphasizing the diagnostic complexity in this subgroup and the necessity to keep low threshold for doing MSGB in suspected cases of SjD. The study also suggests that seronegative SjD may represent a distinct phenotype, warranting novel diagnostic strategies with further multicenter validation. Disclosure M. Sunny: None.
Maria Sunny (2026) studied this question.