Souza 2013.

Study characteristics
Patient Sampling	Method of sampling: unclear Included conditions: "occlusal surfaces varying from sound to having different stages of carious lesions" Teeth: primary molars Sealants: no Surface: occlusal
Patient characteristics and setting	Age: not reported Sex: not reported Ethnicity: not reported Country: Brazil Setting: extracted teeth Number of participants/teeth/sites: 79 teeth (42 first molars and 37 second molars) Prevalence: enamel 0.76, dentine 0.35
Index tests	Category of test: DIAGNOdent, DIAGNOdent pen, and VistaProof Sequence of test(s): visual, radiograph, DIAGNOdent, DIAGNOdent pen, and VistaProof, then reference standard; "teeth were mounted individually on a dental model" Examiner training and calibration: "Two experienced examiners independently assessed the teeth" Teeth cleaning prior to examination: yes, with sodium bicarbonate and water‐powder blasting device for 10 seconds Tooth drying prior to examination: not reported Threshold applied: thresholds calculated within study: DIAGNOdent: 0‐15 sound, 16‐20 outer enamel, 21‐30 inner enamel, > 30 dentine DIAGNOdent pen: 0‐19 sound, 20‐23 outer enamel, 24‐35 inner enamel, > 3 dentine VistaProof: 0‐1.1 sound, 1.2‐1.4 outer enamel, 1.5‐1.6 inner enamel, > 1.6 dentine Device specifics: tip A for the DIAGNOdent and the cylindrical sapphire fibre tip for DIAGNOdent pen. VistaProof: "The software (DBSWIN, Dürr Dental) digitised the video signal to create the occlusal surface images of 720×576 pixels with 3×8 bit intensities of RGB channels and resolution of 72 pixels/in"
Target condition and reference standard(s)	Category: histology Sequence of index test and reference standard: index test before reference standard Training of examiner: "experienced senior researcher, who did not take part in the examination" Blinding to index test: not reported Multiple tests: no Site selection: sectioned teeth Target condition: enamel or 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)?	No
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)
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)?	No
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 (Red fluorescence)
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?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low 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