Human Papilloma Virus Testing and p16 Immunohistochemistry as Ancillary/Reflex Tests in ASC-H Cervical-Vaginal Cytology
Sreeharsha N Masineni, Muhammad Zulfiqar, Tatyana Kalinicheva, Tamar Giorgadze, Sudeshna Bandyopadhyay, Hui Guan, Paul Tranchida, Dongping Shi, Shashi Madan, Vinod B Shidham. Wayne State University School of Medicine and Detroit Medical Center, Detroit, MI
Background: 'Atypical squamous cells – cannot exclude HSIL' (ASC-H) category in The 2001 Bethesda Terminology System continues to be a challenging area. The current ASCCP (American Society of Colposcopy and Cervical Pathology) guidelines recommend a colposcopic biopsy evaluation for ASC-H. As a part of IRB approved study at our tertiary care institution with extensive outreach component during the period of Jan 2010 to Aug 2011, we analyzed ASC-H interpretations in ThinPrep cervical cytology (TP) in relation to surgical pathology findings and results of Digene Hybrid Capture 2 High-Risk HPV DNA Test (HPVT).
Design: The database was searched for availability of surgical pathology (including p16 immunostaining) and HPVT for all ASC-H cases during this period. Positive predictive value (PPV) and negative predictive value (NPV) were calculated for HPVT & p16 with reference to surgical pathology results in ASC-H cases.
Results: We studied 754 TP with ASC-H from 722 patients with a mean age of 35.3 years. HPVT was available in 300 cases (115 with biopsy & 185 without biopsy). The results of surgical pathology including p16 and HPVT were analyzed (Table 1).
|Total cases: 132446 (Over 20 months - Jan 2010 to Aug 2011) in TP|
|ASC-H Cases: 754|
|Biopsy (276 cases)||HPVT with biopsy (115)||p16 IHC with HPVT (28)||p16 IHC without HPVT (35)|
|P/N||p16 - P; HPV - P||p16 - P; HPV - N||p16 - N; HPV - P||p16 - N; HPV - N||P/N|
|No Dysplasia - 142 cases (51%)||11/50||0||0||1||6||0/12|
|CIN-1 - 58 cases (21%)||13/14||3||5||1||1||10/0|
|≥CIN-2 - 76 cases* (28%)||23/4||11||4||0||0||11/2*|