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Background   In vivo  reflectance confocal microscopy ( RCM ) is a promising non‐invasive skin imaging technique that could facilitate early diagnosis of basal cell carcinoma ( BCC ) instead of routine punch biopsies. However, the clinical value and utility of  RCM  vs. a punch biopsy in diagnosing and subtyping  BCC  is unknown.    Objective  To assess diagnostic accuracy of  RCM  vs. punch biopsy for diagnosing and subtyping clinically suspected primary  BCC .    Methods  A prospective, consecutive cohort of 100 patients with clinically suspected  BCC  were included at two tertiary hospitals in Amsterdam, the Netherlands, between 3 February 2015 and 2 October 2015. Patients were randomized between two test‐treatment pathways: diagnosing and subtyping using  RCM  imaging followed by direct surgical excision ( RCM  one‐stop‐shop) or planned excision based upon the histological diagnosis and subtype of punch biopsy (standard care). The primary outcome was the agreement between the index tests ( RCM  vs. punch biopsy) and reference standard (excision specimen) in correctly diagnosing  BCC . The secondary outcome was the agreement between the index tests and reference standard in correctly identifying the most aggressive  BCC  subtypes.    Results  Sensitivity to detect  BCC  was similar for  RCM  and punch biopsy (100% vs. 93.94%), but a punch biopsy was more specific than  RCM  (79% vs. 38%).  RCM  expert evaluation for diagnosing  BCC  had a sensitivity of 100% and a specificity of 75%. The agreement between  RCM  and excision specimen in identifying the most aggressive  BCC  subtype ranged from 50% to 85% vs. 77% by a punch biopsy.    Conclusion  Reflectance confocal microscopy and punch biopsy have comparable diagnostic accuracy to diagnose and subtype  BCC  depending on  RCM  experience. Although experienced  RCM  users could accurately diagnose  BCC  at a distance, we found an important difference in subtyping  BCC . Future  RCM  studies need to focus on diagnostic accuracy, reliability and specific criteria to improve  BCC  subtype differentiation.

Diagnostic accuracy of confocal microscopy imaging vs. punch biopsy for diagnosing and subtyping basal cell carcinoma