Objectives. The objective of this study was to examine the diagnostic value of cutting labial salivary gland (LSG) biopsies at 2 levels in the histological evaluation for Sjogren's syndrome (SS).

Study Design. This retrospective study included LSG biopsy specimens from 112 consecutive patients evaluated for SS from 2007 to 2019. Three observers, blinded with regard to patient data, independently scored the degree of focal lymphocytic infiltration (foci) and calculated the focus score in specimens cut at 2 levels 60 mu m apart.

Results. Unblinded analysis revealed that the LSG specimens derived from 107 women and 5 men, aged 49.2 +/- 22.3 years. Seventy-six patients had SS (70 primary SS and 6 secondary SS) according to the American-European Consensus Group and American College of Rheumatology/European League Against Rheumatism criteria. The average number of LSGs was 5.0 +/- 1.4 and the focus scoring area was 16.1 +/- 7.6 mm(2). Compared to baseline, the average number of foci (4.4 vs 5.1, P <.001), focus score (1.7 vs 1.9, P = .01), and cases with focus score >1.0 (61 vs 74%; P = .03) were higher in the second level. Subsequently, an additional 11 cases of SS were confirmed (14%), and 8 non-SS cases were reclassified as SS (22%).

Conclusions. Histological assessment of an additional section level improves the diagnostic accuracy of the labial salivary gland biopsy to detect histopathological changes consistent with the diagnosis of SS.