Neuhaus 2011.

Study characteristics
Patient Sampling	Method of sampling: selected Included conditions: unclear Teeth: primary molars (first and second) Sealants: unclear Surface: occlusal
Patient characteristics and setting	Age: not reported Sex: not reported Ethnicity: not reported Country: Switzerland Setting: extracted teeth Number of participants/teeth/sites: 37 teeth/37 sites Prevalence: enamel 0.73, dentine 0.24
Index tests	Category of test: DIAGNOdent and DIAGNOdent pen Sequence of test(s): index tests (visual, DIAGNOdent devices then radiograph) then reference standard Examiner training and calibration: experienced examiners Teeth cleaning prior to examination: 3 in 1 syringe Tooth drying prior to examination: not reported Threshold applied: "D1 and D3 were determined according to se and sp" DIAGNOdent: 0‐9 sound, 10‐11 enamel, 17+ dentine DIAGNOdent pen: 0‐13 sound, 14‐30 enamel, 31+ dentine Device specifics: DIAGNOdent ‐ tip A; DIAGNOdent pen ‐ cylindrical sapphire fibre tip
Target condition and reference standard(s)	Category: histology Sequence of index test and reference standard: index test then reference standard Training of examiner: not reported Blinding to index test: not reported Multiple tests: no Site selection: unclear Target condition: sound, outer half of enamel, inner half of enamel, outer half of dentine, deep dentine
Flow and timing	Participants with index test but no reference standard: 0 Participants with reference standard but no index test: 0 Time interval between tests: minimal Participants receiving both tests but excluded from results: 0
Comparative
Notes
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	No
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Unclear
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (All)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	No
If multiple tests were applied were different examiners used for each (in vivo)?	Unclear
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 2: Index Test (Green fluorescence)
DOMAIN 2: Index Test (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	No
If multiple tests were applied were different examiners used for each (in vivo)?	Unclear
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Low risk