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||Cervical histopathology variability among laboratories: a population-based statewide investigation.
||Gage JC, Schiffman M, Hunt WC, Joste N, Ghosh A, Wentzensen N, Wheeler CM, New Mexico HPV Pap Registry Steering Committee, Joste NE, Kinney W, Wheeler CM, Hunt WC, Thompson D, Baum S, Gorgos L, Waxman A, Espey D, McGrath J, Jenison S, Schiffman M, Castle P, Benard V, Saslow D, Kim JJ, Stoler MH, Cuzick J, Pressley GR, English K
||Am J Clin Pathol
||To inform the proposed systematic adjudicative staining of cervical intraepithelial neoplasia grade 2 (CIN2) and equivocal diagnoses, we characterized diagnostic heterogeneity across 15 laboratories. Laboratory-specific distributions of 37,486 biopsy specimen diagnoses were compared after adjusting for preceding cytology. In a subset of preceding cytology specimens, HPV16 genotyping was considered an indicator of lesion severity. Distributions of normal and CIN1 diagnoses varied widely, with laboratories favoring either normal (5.5%-57.7%) or CIN1 diagnoses (23.3%-86.7%; P < .001 for normal:CIN1 variability). Excluding extreme values, 6.2% to 14.4% of diagnoses were CIN2 (P < .001). For CIN2 diagnoses, HPV16 positivity in the preceding cytology varied between 39.0% in the largest laboratory and 57.4% in others (P < .001), suggesting differential interpretation, not population differences, as a cause of variability. In conclusion, the frequency of diagnoses requiring special staining (p16(INK4a) immunostaining) to adjudicate equivocal CIN2 will be sizable and vary between laboratories, especially if extended to a fraction of CIN1 lesions.