ABSTRACT
INTRODUCTION: HPV is known to have a predilection for infecting the transformation zone (TZ). Endocervical cells (EC) on a Pap test (PT) indicate that the cervical TZ has been sampled. Earlier repeat testing of women lacking EC is of little value in further detecting disease, thus a sample without EC is not necessarily inadequate. Both HPV testing and PT can be performed using a single sample; however, few studies have investigated the relationship between HPV results and TZ sampling. MATERIALS AND METHODS: Specimens were collected following the ThinPrep(®) liquid-based PT protocol. The Roche Cobas(®) HPV test was performed on post-aliquot samples. Data was collected retrospectively on 500 patients: 250 consecutive cases of EC- and 250 of EC+ on PT. To maintain uniformity, we included only cases diagnosed as negative (NILM). We compared HPV test results within each category. As a positive control, five consecutive cases each of LSIL and HSIL were also reviewed. RESULTS: Of NILM cases, 11 of 250 EC+ cases and 14 of 250 EC- cases were positive for hrHPV. HPV 16 was present in 5 of 11 EC + cases and in 1 of 14 EC- cases. Of LSIL cases, 1 of 5 EC+ cases was positive for hrHPV, and 2 of 5 EC- cases were positive for hrHPV. Of HSIL cases, 5 of 5 EC+ cases were hrHPV+. In the time period studied, only one case of EC- HSIL was found, which was positive for hrHPV. DISCUSSION: Although our study did not prove a significant correlation between HPV testing results and EC on PT, more EC+ PTs were positive for HPV16 compared to EC- PTs. The absence of EC on PT does not appear to warrant re-testing for HPV infection, though larger studies are required to determine the significance of low HPV 16 in PT without EC. Diagn. Cytopathol. 2016;44:280-282. © 2016 Wiley Periodicals, Inc.
Subject(s)
Biological Assay , DNA, Viral/genetics , Human papillomavirus 16/genetics , Papillomavirus Infections/diagnosis , Uterine Cervical Dysplasia/diagnosis , Uterine Cervical Neoplasms/diagnosis , Adolescent , Adult , Cervix Uteri/pathology , Cervix Uteri/virology , DNA, Viral/isolation & purification , Female , Human papillomavirus 16/isolation & purification , Humans , Middle Aged , Papanicolaou Test , Papillomavirus Infections/pathology , Papillomavirus Infections/virology , Pilot Projects , Retrospective Studies , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/virology , Vaginal Smears , Uterine Cervical Dysplasia/pathology , Uterine Cervical Dysplasia/virologyABSTRACT
Recent reports show that the sensitivity of endometrial carcinoma detection on liquid-based Papanicolaou (Pap) tests (88%) is considerably higher than that reported on conventional Pap smears (20%-30%), although few laboratories have corroborated these results. We performed a 5-year retrospective review of all liquid-based Pap tests (n = 69) in women who later were given a diagnosis of endometrial carcinoma, performed error root cause analysis, and developed quality improvement initiatives as a means of error reduction. The original and rescreened Pap test sensitivity rates for endometrial carcinoma were 31.9% and 59.3%, respectively. Root cause analysis showed that poor specimen quality and cognitive failures contributed to a false-negative error in 67% (18/27) and 59% (16/27), respectively, of all cases. System analysis showed that latent factors contributing to error included lack of redundant and educational systems. We conclude that system redesign of liquid-based Pap test screening processes has the potential to improve sensitivity in endometrial carcinoma diagnosis.
Subject(s)
Adenocarcinoma/diagnosis , Diagnostic Errors/prevention & control , Endometrial Neoplasms/diagnosis , Papanicolaou Test , Quality Improvement , Vaginal Smears/methods , Adult , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Predictive Value of Tests , Retrospective Studies , Specimen Handling , Vaginal Smears/standardsABSTRACT
Although rapid prescreening (RPS) has been shown to be an effective quality control procedure for detecting false-negative conventional Papanicolaou (Pap) tests, RPS has not been widely implemented in the United States. In our laboratory, cytotechnologists performed RPS in 3,567 liquid-based Pap tests: 1,911 SurePath (BD Diagnostics-TriPath, Burlington, NC) preparations that were manually screened and 1,656 ThinPrep Pap tests (Hologic, Bedford, MA) that were imaged using the ThinPrep Imaging System (Hologic). We compared the sensitivity of RPS, 10% rescreening (R-10%), and routine screening (RS). In contrast with previously published findings, we found that RS + RPS did not improve screening sensitivity compared with RS + R-10%. These results support the following hypotheses: (1) Higher baseline RS sensitivity as a result of Pap test diagnoses standardization implemented for quality improvement purposes decreases the performance impact of RPS. (2) R-10% and RPS quality assurance methods detect diagnostic failures caused by different types of cognitive errors.
