A human papillomavirus testing system in women with abnormal Pap results: a comparison study with follow-up biopsies.
OBJECTIVE
To evaluate the efficacy of INFORM HPV using the SurePath collection method in women whose Pap tests indicated abnormal results.


METHODS
Ninety-two women from the gynecology clinics at The University of Texas M.D. Anderson Cancer Center who had Pap tests and underwent follow-up biopsies were selected for the study. This included 51 women with atypical squamous cells of undetermined significance (ASCUS), 23 women with low-grade squamous intraepithelial lesion (LSIL), 15 women with high-grade squamous intraepithelial lesion (HSIL) and 3 women with negative Pap results. The INFORM HPV, an in situ hybridization assay, testing for oncogenic types of HPV was performed, and the results were compared with follow-up biopsies.


RESULTS
The positive rate of the INFORM HPV increased with higher grades of cytology diagnoses. The sensitivity of the INFORM HPV testing for predicting high-grade cervical intraepithelial neoplasia (CIN 2/3) also increased with higher grades of cytology diagnoses. A negative predictive value (NPV) of 94.9% and a specificity of 80.4% for predicting CIN 2/3 were observed in the ASCUS group.


CONCLUSIONS
Using SurePath Pap specimens, the INFORM HPV lacks sufficient sensitivity and NPV for predicting CIN 2/3 in women with ASCUS. Therefore, use of the test as a triage tool is limited.
Guo
Ming
M
Departments of Pathology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030-4009, USA.
Patel
Shobha J
SJ
Chovanec
Marilyn
M
Jan
Yee Jee
YJ
Tarco
Emily
E
Bevers
Therese B
TB
Anderson
Keith
K
Sneige
Nour
N
D000328:Adult; D000368:Aged; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D001706:Biopsy; D015344:DNA Probes, HPV; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017403:In Situ Hybridization; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000473:pathology* / Q000821:virology*
D015344:DNA Probes, HPV; D004279:DNA, Viral