Implementation of the International System for Reporting Serous Fluid Cytopathology (ISRSFC): Diagnostic Concordance Analysis between Liquid-based Cytology Preparation Methods
Abstract
Objective: To evaluate the diagnostic concordance between EasyPrep and ThinPrep liquid-based cytology systems using the International System for Reporting Serous Fluid Cytopathology (ISRSFC).
Material and Methods: This prospective study analyzed 555 serous effusion specimens (316 pleural, 218 peritoneal, 21 pericardial) processed in parallel using both LBC methods. Two cytopathologists independently categorized cases according to ISRSFC: nondiagnostic (ND), negative for malignancy (NFM), atypia of undetermined significance (AUS), suspicious for malignancy (SFM), and malignant (MAL). Diagnostic concordance, risk of malignancy (ROM), and performance parameters were calculated with histopathological correlation.
Results: Overall diagnostic concordance was 94.4% with a weighted kappa of 0.912 (95% CI: 0.887-0.937). Distribution for ThinPrep vs EasyPrep: ND 2.5% vs 2.9%, NFM 71.0% vs 70.1%, AUS 2.2% vs 2.7%, SFM 2.3% vs 2.0%, MAL 22.0% vs 22.3%. ROM showed no significant differences between methods: NFM 7.8% vs 8.2%, AUS 60.0% vs 58.3%, SFM 81.8% vs 80.0%, MAL 98.3% vs 97.5%. Both methods demonstrated comparable diagnostic performance: sensitivity 89.5% vs 90.1%, specificity 96.8% vs 96.3%, accuracy 93.6% vs 93.7% (all p-value>0.05). Inter-observer agreement was substantial (κ=0.782-0.798). Minor cytomorphological differences did not impact diagnostic interpretation.
Conclusion: EasyPrep and ThinPrep systems show excellent diagnostic concordance for ISRSFC implementation. Both methods provide equivalent ROM assessment and diagnostic accuracy, supporting laboratory flexibility in LBC platform selection while maintaining standardized reporting quality.
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