Table 4 Data of index test methods and reference methods in the studies included in the review

Al-Hashimi 1998 [31]

3 different gel electrophoresis systems

European Community criteria for the diagnosis of Sjögren’s syndrome [42]

Salivary electrophoresis is a potentially useful test for the diagnosing of Sjögren’s syndrome

▪SDS-PAGE

▪anionic-PAGE

▪immobilized pH gradient (IPG)

Almståhl 2003 [32]

Sialochemistry

The Copenhagen criteria for Sjögren’s syndrome [47]

The concentrations of electrolytes in stimulated whole saliva, in individuals with hyposalivation, seem to be more related to the reason for the hyposalivation than to the salivary secretion rate.

El-Miedany 1999 [33]

Salivary smears

Criteria of Fox et al. for Sjögren’s syndrome [48]

The saliva ferning test is a useful diagnostic aid in autoimmune xerostomia, approx equivalent to Shrimer’s test in xeropthalmia

Håkansson 1994 [34]

^99mTc-scintigraphy

▪Copenhagen criteria for pSS [47]

Salivary gland scintigraphy is a sensitive and valid method to measure salivary gland function and abnormalities

▪Shrimer-1 test

▪van Bijsterveld score

▪Tear-film break-up time

Hay 1998 [35]

Questionnaire

▪Sialometry [42–44]

Only weak associations were found between self-reported symptoms of dry eyes and dry mouth and objective measures said to define Sjögren’s syndrome in the general population

▪Shrimer-1 test

▪Measurement of antibodies (ELISA, indirect immunofluorescence, Latex test)

Kalk 2001 [36]

▪Sialometry

Revised European classification criteria for SS [43–45]

Glandular sialometry and sialochemistry are not useful tools for differentiating SS from other salivary gland disease.

▪Sialochemistry

Parotid sialography was used to fulfill the criteria on the oral component.

Kalk 2002 [37]

▪Sialometry

Revised European classification criteria for SS [43–45]

Gland-specific sialometry and sialochemistry may eventually replace other, more invasive, diagnostic techniques for diagnosing SS.

▪Sialochemistry

Parotid sialography was used to fulfill the criteria on the oral component.

Kanehira 2009 [38]

Filter paper comprising 3 spots containing 30 μg starch and 49.6 μg potassium iodide per spot.

Sialometry (unstimulated whole saliva < 0.1 ml/min)^a

This screening technique might be effective for estimation of salivary flow.

Kohn 1992 [39]

^99mTc-scintigraphy

Sialometry (Unstimulated parotid and SM/SL < 0.1 ml/min Stimulated parotid and SM/SL < 0.6 ml/min)*

Salivary gland scintigraphy is a useful method in assessing salivary gland flow rates

Lee 2002 [40]

▪Oral mucosal wetness

Sialometry (unstimulated whole saliva <0.15 ml/min) ^a

Measurements of oral mucosal wetness could be thought of as one of the diagnostic methods for assessing dry mouth.

▪Sialochemistry

(Sialopaper^TM Periotron 8000®)

López-Jornet 2006 [41]

Oral Schirmer’s test

Revised European classification criteria for SS [46]

Oral Shrimer’s test can be used as a simple, objective test to diagnose salivary gland hypofunction.

Navazesh 1992 [42]

▪Lip dryness

Sialometry (unstimulated whole saliva ≤0.20 ml/min) ^a

Four clinical measures that together predict the presence of or absence of salivary gland hypofunction were identified: dryness of lips, dryness of buccal mucosa, absence of saliva produced by gland palpation, and total DMFT.

▪Buccal mucosal dryness

▪Salivary pool

▪Major salivary gland palpation

▪Tongue mucosa

▪Periodontium

▪Total DMFT

Pedersen 1999 [43]

▪Sialometry

European classification for pSS [42]

Rating of oral dryness by visual analogue scales or categorised questionnaires are valuable for the evaluation of oral involvement in pSS.

▪Labial salivary gland biopsy

▪Serological examination

▪Interview

▪Categorised questionnaire

▪VAS

Pennec 1993 [44]

▪Sialometry

European classification for pSS [42]

The most efficient combination of tests for the oral component of SS appears to be salivary gland scintigraphy plus saliva flow rate or salivary lactoferrin.

▪Salivary lysozyme

▪Salivary lactofferin

▪Parotic sialography

▪Salivary gland scintigraphy (^99mTc)

▪Labial salivary gland biopsy

Sánchez-Guerrero 2002 [45]

Wafer test

For the oral component parotid secretion rate according to Fox et al. [48]

The wafer test is valid and reliable for identifying subjects with xerostomia

▪European questionnaire for sicca syndrome

▪Schirmer-1 test

Sreebny 1988 [4]

Questionnaire

Sialometry (unstimulated whole saliva ≤ 0.1 ml/min) ^a

Dry mouth and several other symptoms are common in an outpatient population and they are a valid indicator of salivary gland hypofunction

Wolff 1998 [46]

Oral mucosal wetness(Sialopaper^TM Periotron 6000®)

Sialometry (unstimulated whole saliva ≤ 0.1 ml/min) ^a Salivary pH

Measurement of palatal mucosal wetness might be useful in assessing medication compliance and may serve as a guide to medication administration.

Wolff 2002 [47]

3-g-all-sucrose candy

Sialometry (unstimulated SM/SL < 0.1 ml/min + either stimulated parotid <0.25 ml/min or stimulated SM/SL < 0.15 ml/min) ^a

The candy weight-loss test is a measure of salivary hypofunction, which correlates with saliva output and reports of subjective dry mouth