Results of the 3-phase assessment.
| Test | Primary SS, n = 50 | RA, n = 100 | SLE, n = 100 | Scleroderma, n = 100 |
|---|---|---|---|---|
| Screening phase | ||||
| Questionnaire, n (%) | ||||
| Ocular section | 49 (98) | 41 (41) | 31 (31) | 40 (40) |
| Oral section | 49 (98) | 26 (26) | 31 (31) | 37 (37) |
| Schirmer-I test | 45 (90) | 53 (53) | 33 (33) | 59 (59) |
| Wafer test | 47 (94) | 70 (70) | 55 (55) | 76 (76) |
| Positive screening* | 50 (100) | 89 (89) | 70 (70) | 91 (91) |
| Confirmatory phase, n (%) | ||||
| Low NSWSF | 48 (96) | 52 (58) | 48 (68) | 68 (74) |
| Fluorescein stain** | 26 (52) | 38 (43) | 26 (29) | 42 (50) |
| Anti-Ro/La antibodies | 41 (82) | 11 (12) | 23 (32) | 33 (36) |
| Lip biopsy, n (%) | ||||
| Lip biopsy indicated†, n | 50 | 66 | 55 | 80 |
| Lip biopsy performed | 25 (50) | 28 (42) | 23 (41) | 31 (38) |
| Focal lymphocytic infiltration†† | 18 (75) | 16 (61) | 8 (36) | 20 (64) |
| Nonfocal lymphocytic infiltration†† | 6 (25) | 10 (35) | 14 (63) | 9 (29) |
| Normal biopsy | 0 | 0 | 0 | 2 (6) |
↵* At least one affirmative response to the screening questionnaire (oral or ocular), Schirmer-I test ≤ 5 mm in 5 minutes, or wafer test > 4 minutes.
↵** Fluorescein stain test in 50 patients with primary SS, 87 with RA, 68 with SLE, and 83 with scleroderma.
↵† Indicated if ≥ 2 of the following results: (1) at least one affirmative answer to the oral component of the screening questionnaire; (2) wafer test > 4 min; (3) presence of keratitis by the fluorescein stain test; (4) nonstimulated whole salivary flow rate (NSWSF) < 0.3 ml/min; and (5) positive anti-Ro and/or anti-La antibodies.
↵†† Percentages of focal and nonfocal lymphocytic infiltration are calculated based on number of biopsies performed minus biopsies discarded in each group: 1 in primary SS, 2 in RA, and 1 in SLE.