CINtec PLUS and cobas HPV testing for triaging Canadian women referred to colposcopy with a history of low-grade squamous intraepithelial lesion: Baseline findings

Abstract Context.—Oncogenic, high-risk human papillomavirus (HR-HPV) testing is used to evaluate women who are older than 20 years with atypical squamous cells of undetermined significance (ASC-US) and in conjunction with a screening Papanicolaou test in women older than 30 years. Objectives.—To evaluate the 2006 laboratory practice data from laboratories incorporating human papillomavirus (HPV) testing with the Papanicolaou test. Design.—To use the College of American Pathologists (CAP) Supplemental Questionnaire Survey for 2006 to determine laboratory practices of participants in the CAP Interlaboratory Comparison Program in Cervicovaginal Cytology. Results.—A total of 679 laboratories responded to the questionnaire. Most (73%) refer HPV testing to reference laboratories. Nine percent perform HPV testing in cytology. Forty-five percent offer low-risk HPV (LR-HPV) testing. The most common reflex is ASC-US, although HR-HPV is also offered with low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), or any other Papanicolaou test result. Digene Hybrid Capture II is the most common method. Human papilloma virus median test volumes are 55 monthly. Frequency distributions of HPV test volumes are significantly different from those found in 2003. Laboratories performing in-house testing reported significantly higher monthly HPV volumes (P < .001). Median rates for HR-HPV positivity are 36.6% for ASC-US, 50.0% for atypical squamous cells, cannot exclude HSIL (ASC-H), and 4% for women 30 years of age and older in conjunction with a screening Papanicolaou test. Conclusions.—Reference HPV testing remains the most common pattern. The most common reflex indication is for ASC-US, but HPV testing is modified locally to include a variety of scenarios. LR-HPV testing is commonly offered despite its lack of clinical significance. These data form a baseline for ongoing monitoring of HPV testing practice trends.

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Bethesda 2014 Implementation and Human Papillomavirus Primary Screening: Practices of Laboratories Participating in the College of American Pathologists PAP Education Program

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2018-0603-cp ◽

2019 ◽

Vol 143 (10) ◽

pp. 1196-1202 ◽

Cited By ~ 7

Author(s):

Diane Davis Davey ◽

Rhona J. Souers ◽

Kelly Goodrich ◽

Dina R. Mody ◽

Sana O. Tabbara ◽

...

Keyword(s):

Human Papillomavirus ◽

Education Program ◽

Cervical Cytology ◽

Current Status ◽

Low Grade ◽

Hpv Testing ◽

Squamous Intraepithelial Lesion ◽

Primary Screening ◽

Intraepithelial Lesion ◽

Bethesda System

Context.— Cervical cancer screening laboratory practices may evolve with new terminology and technologies. Objective.— To investigate changes in cervical cytopathology practice resulting from the 2014 Bethesda System updates and screening technologies. Design.— Questionnaires accompanied 2016 and 2017 mailings of the College of American Pathologists PAP Education program. Results.— In 2016, most laboratories surveyed had adopted or were planning to adopt 2014 Bethesda System updates, and the majority (53%; 365 of 689) used an age cutoff of 45 for reporting benign-appearing endometrial cells. However, 51.3% (354 of 690) of laboratories used the term low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion, for cases with indeterminate features, and 44.9% (298 of 664) of laboratories used a 5000-cell cutoff for minimum squamous cellularity for posthysterectomy and posttherapy specimens. Reporting rates for cervical cytology metrics changed very little from 2013 to 2016, and the median ratio of atypical squamous cells to squamous intraepithelial lesion cases was 1.9 for ThinPrep and 1.8 for SurePath preparations. Most laboratories (59.4%; 389 of 655) did not offer stand-alone primary human papillomavirus (HPV) testing in 2017, and primary HPV testing accounted for a low proportion of HPV testing volumes. The Roche Cobas method was the most common platform for HPV primary screening. Conclusions.— These questionnaire surveys provide data about the current status of cervical cytology screening, including changes related to the 2014 Bethesda System updates and the adoption of HPV primary screening techniques.

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HPV Testing in Patient Management: Atypical Squamous Cells of Undetermined Significance and Low- Grade Squamous Intraepithelial Lesion

Emerging Issues on HPV Infections ◽

10.1159/000092742 ◽

2006 ◽

pp. 120-139 ◽

Cited By ~ 1

Author(s):

J. Thomas Cox

Keyword(s):

Patient Management ◽

Low Grade ◽

Hpv Testing ◽

Squamous Intraepithelial Lesion ◽

Squamous Cells ◽

Intraepithelial Lesion ◽

Undetermined Significance

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Adjunctive Human Papillomavirus Testing in the 2-Year Follow-up of Women With Low-Grade Cervical Cytologic Abnormalities: A Randomized Trial and Economic Evaluation

Archives of Pathology & Laboratory Medicine ◽

10.5858/2003-127-1169-ahptit ◽

2003 ◽

Vol 127 (9) ◽

pp. 1169-1175 ◽

Cited By ~ 2

Author(s):

Alice Lytwyn ◽

John W. Sellors ◽

James B. Mahony ◽

Dean Daya ◽

William Chapman ◽

...

Keyword(s):

Human Papillomavirus ◽

Cervical Intraepithelial Neoplasia ◽

Pap Test ◽

Intraepithelial Neoplasia ◽

Low Grade ◽

High Grade ◽

Hpv Testing ◽

Squamous Intraepithelial Lesion ◽

Intraepithelial Lesion

Abstract Context.—Although human papillomavirus (HPV) testing may aid in managing low-grade abnormality on screening cervical cytology, patient compliance with repeat testing programs requires consideration. Objectives.—To determine effectiveness and costs of repeated Papanicolaou (Pap) test and oncogenic HPV testing for detecting cervical intraepithelial neoplasia 2 or 3. Design.—We conducted a randomized controlled trial of combined Pap test and cervical HPV testing by Hybrid Capture 1 test compared with Pap test alone; tests were performed every 6 months for up to 2 years. The study end point was colposcopic examination performed on all women at 2 years, or earlier if an HPV test was positive or if a Pap test showed high-grade squamous intraepithelial lesion. Setting.—Sixty-six community family practices. Participants.—Two hundred fifty-seven women with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion on screening cervical cytology. Main Outcome Measures.—Detection of histologically confirmed cervical intraepithelial neoplasia 2 or 3, fully allocated costs, and loss to follow-up. Results.—Combined Pap test and HPV testing detected 11 (100%) of 11 cases of cervical intraepithelial neoplasia 2/3, whereas Pap test alone detected 7 (63.6%) of these 11 cases (P = .14); corresponding specificities were 39 (46.4%) of 84 and 45 (71.4%) of 63 (P = .005). The cost-effectiveness ratio was Can $4456 per additional case of high-grade cervical intraepithelial neoplasia. Sixty-nine (26.8%) of the 257 women (24.6% combined group vs 29.1% Pap test only group, P = .41) defaulted from testing or from colposcopy when referred with an abnormal result. Conclusions.—Combined testing was more costly but may detect more cases of cervical intraepithelial neoplasia 2/3 than Pap test alone. However, poor adherence limits usefulness of a management strategy that requires repeated follow-up.

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Correlation of Histopathologic Follow-up Findings With Vaginal Human Papillomavirus and Low-Grade Squamous Intraepithelial Lesion Papanicolaou Test Results

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2010-0658-oa ◽

2011 ◽

Vol 135 (12) ◽

pp. 1545-1549 ◽

Cited By ~ 11

Author(s):

Mona Bansal ◽

R Marshall Austin ◽

Chengquan Zhao

Keyword(s):

Human Papillomavirus ◽

Low Grade ◽

Hpv Testing ◽

Test Results ◽

Squamous Intraepithelial Lesion ◽

Papanicolaou Test ◽

Dna Test ◽

Correlation Data ◽

Intraepithelial Lesion

Context.—Data on high-risk human papillomavirus (hrHPV) DNA test results in vaginal, liquid-based cytology (LBC) specimens and corresponding cytologic and histopathologic correlation data are limited. Objective.—To analyze follow-up correlation data associated with vaginal (after hysterectomy) low-grade squamous intraepithelial lesion (LSIL) LBC and hrHPV test results. Design.—Hospital records were searched for vaginal LSIL LBC and hrHPV results between July 1, 2005, and July 30, 2009. Histopathologic and Papanicolaou test follow-up correlation data were analyzed. Results.—During the study period, 2892 patients with test results from both posthysterectomy vaginal LBC and hrHPV were identified: 148 (5.1%) of the patients had vaginal Papanicolaou test results reported as LSIL, with hrHPV detected in 113 of the 148 patients (76.4%). Of 148 patients, 59 of those with vaginal LSIL including 48 (81.4%) with positive HPV testing and 11 (18.6%) with negative HPV testing results had a follow-up vaginal biopsy. Histopathologic vaginal intraepithelial neoplasia (VAIN) 2/3 was diagnosed in 7 of 59 patients (11.9%) with biopsies. In all 7 patients who were diagnosed with VAIN 2/3, hrHPV was detected in the LBC vial. No VAIN 2/3 diagnoses were documented in the biopsy specimens from the 11 patients with hrHPV− LSIL Papanicolaou test results. Histopathologic VAIN 2/3 was diagnosed from vaginal biopsies in 7 of the 48 patients (14.6%) with vaginal hrHPV+ LSIL test results. Conclusions.—Sensitivity and specificity of hrHPV test results associated with histopathologic follow-up diagnoses of VAIN 2/3 in patients with vaginal LSIL results were 100% and 21.2%, respectively. The positive predictive value of a vaginal hrHPV+ LSIL result for a subsequent histopathologic VAIN 2/3 diagnosis was 14.6%. No cases of VAIN 2/3 were diagnosed in the 11 patients with vaginal hrHPV− LSIL results. Correlations of vaginal cytologic, histopathologic, and human papillomavirus findings were quite similar to correlation findings previously reported in older women with cervical LSIL test results.

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Natural History of Low-Grade Squamous Intraepithelial Lesion

Journal of Lower Genital Tract Disease ◽

10.1097/00128360-200107000-00006 ◽

2001 ◽

Vol 5 (3) ◽

pp. 153-158

Author(s):

Ho-Suk Saw ◽

Jae-Kwan Lee ◽

Hwa-Lynn Lee ◽

Hyun-Jun Jee ◽

Jong-Jin Hyun

Keyword(s):

Natural History ◽

Low Grade ◽

Squamous Intraepithelial Lesion ◽

History Of ◽

Intraepithelial Lesion

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Natural History of Low-Grade Squamous Intraepithelial Lesion

Obstetrical & Gynecological Survey ◽

10.1097/00006254-200203000-00012 ◽

2002 ◽

Vol 57 (3) ◽

pp. 153-154

Author(s):

Ho-Suk Saw ◽

Jai-Kwan Lee ◽

Hwa-Lynn Lee ◽

Hyun-Jun Jee ◽

Jong-Jin Hyun

Keyword(s):

Natural History ◽

Low Grade ◽

Squamous Intraepithelial Lesion ◽

History Of ◽

Intraepithelial Lesion

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ATL

International Journal of Gynecological Cancer ◽

10.1097/igc.0b013e31828f39a0 ◽

2013 ◽

Vol 23 (5) ◽

pp. 785-790 ◽

Cited By ~ 5

Author(s):

Xiuhui Zheng ◽

Peihe Liang ◽

Yingru Zheng ◽

Ping Yi ◽

Qiang Liu ◽

...

Keyword(s):

In Situ Hybridization ◽

Gene Amplification ◽

Predictive Value ◽

Low Grade ◽

Hpv Testing ◽

Squamous Intraepithelial Lesion ◽

Cervical Lesions ◽

Cin Iii ◽

Intraepithelial Lesion

ObjectiveTo investigate the clinical significance of abnormal human telomerase RNA gene component (hTERC) gene amplification tested by fluorescence in situ hybridization in cervical lesions.MethodsIn 373 patients with cytologic abnormalities, high-risk human papilomavirus (HR-HPV) was detected by the hybrid capture II method, and abnormal amplification of the hTERC gene in exfoliated cells was detected by fluorescence in situ hybridization.ResultsCell smear findings suggested atypical squamous cells in 148 patients, low-grade squamous intraepithelial lesion in 62 patients, and high-grade squamous intraepithelial lesion in 107 patients, squamous cell carcinoma in 56 patients, and cervical biopsy-revealed inflammation in 89 patients, cervical intraepithelial neoplasia (CIN) I in 36 patients, CIN II in 43 patients, CIN III in 129 patients, and infiltrating carcinoma in 76 patients. In the inflammation, CIN I, CIN II, CIN III, and infiltrating carcinoma groups, the infection rates of HR-HPV were 29.21%, 52.78%, 74.42%, 92.25%, and 93.42% (P < 0.01), respectively; the positive rates of hTERC gene amplification were 0.00%, 13.89%, 41.86%, 78.29%, and 89.47% (P < 0.01), respectively. With respect to advanced cervical lesions (≥CIN II), cytology (≥ low-grade squamous intraepithelial lesion), HR-HPV testing, and hTERC testing differed insignificantly in the negative predictive value (P > 0.05), but they differed significantly in the sensitivity, specificity, and positive predictive value (P < 0.01). Among the 3 methods, hTERC testing showed the highest specificity and positive predictive value, and HR-HPV testing showed the highest sensitivity. In 41 patients with untreated CIN I and CIN II, the sensitivity of detection of hTERC gene amplification to predict lesion progression was 88.89%, and the specificity was 93.75%.ConclusionDetection of abnormal amplification of the hTERC gene can assist in screening cervical lesions and identifying CIN I/II patients with a high progression risk.

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