Reflex high-risk human papillomavirus DNA testing (Hybrid Capture 2) of bloody ThinPrep specimens with atypical squamous cells of undetermined significance interpretation

Feng, Jining; Husain, Mujtaba

doi:10.1002/cncr.21349

Cited by 14 publications

(24 citation statements)

References 21 publications

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“…These findings would seem to indicate low cellular yields on specimen collection; in particular, peri/postmenopausal patients and those who had received radiation/chemotherapy. The issue of a glacial acetic acid wash and its effect on HPV analysis has been addressed in the literature with some reporting no effect and others false‐positive HPV results. This issue requires further study and is not in the scope of the current study.…”

Section: Discussionmentioning

confidence: 99%

Factors contributing to high ThinPrep® Pap test unsatisfactory rates in an academic medical center laboratory

Selvaggi

2013

Diagnostic Cytopathology

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Specimen adequacy is a key component in the cytologic evaluation of cervical Pap tests. At our institution, yearly unsatisfactory rates continue to be high, placing our laboratory in the 95th percentile for CAP benchmark data for unsatisfactory Pap test rates. Using the 2001 Bethesda System criteria, unsatisfactory Pap test rates were calculated over a ten year period (January 2002 to December 2011) and contributing factors were analyzed. Of the 124,457 ThinPrep Pap tests performed, 4,163 (3.3%) were unsatisfactory for evaluation, the majority (90%) due to too few squamous epithelial cells. Peri/postmenopausal women and those who had received radiation/chemotherapy had the highest unsatisfactory rates; 55% and 25%, respectively. Higher unsatisfactory Pap test rates are related to the patient population served. Defined, reproducible adequacy criteria need to be defined for Pap tests from patients in certain clinical conditions.

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Section: Discussionmentioning

confidence: 99%

Factors contributing to high ThinPrep® Pap test unsatisfactory rates in an academic medical center laboratory

Selvaggi

2013

Diagnostic Cytopathology

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“…In addition, specimen carryover (potentiated by either form of automation) may be of concern to both laboratorians and cytopathologists. Moreover, previous data (8)(9)(10) suggest that performance characteristics of DNA-based HPV modalities may be affected by glacial acetic acid (GAA) treatment of liquid-based cytology collections. The purpose of this investigation was to assess such preanalytical concerns inherent to the performance of the Aptima HPV.…”

Section: Etection Of High-risk Human Papillomavirus (Hpv) E6/e7mentioning

confidence: 99%

Effect of Preanalytical Processing of ThinPrep Specimens on Detection of High-Risk Human Papillomavirus by the Aptima HPV Assay

et al. 2014

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c Two important preanalytical protocols performed on liquid-based cytological specimens, namely, automated cytology processing and glacial acetic acid (GAA) treatment, may occur prior to the arrival of specimens in a molecular diagnostics laboratory. Ninety-two ThinPrep vials previously positive for high-risk human papillomavirus (HPV) via the Cervista HPV HR test were preselected and alternated with 92 previously negative ThinPrep vials. The specimen set was processed in a consecutive fashion by an automated cytology processor without fastidious decontamination precautions. Carryover potential was subsequently assessed by performance of the Aptima HPV assay on aliquots from reprocessed ThinPrep vials. All previously negative ThinPrep vials yielded a negative result following routine automated cytology processing, despite close proximity to known-positive ThinPrep vials. In separate experiments, aliquots from 236 ThinPrep vials were forwarded for tandem analysis with and without GAA treatment. Data from GAA-and mock-treated specimens generated by Aptima HPV were compared to correlate data generated by Cervista. A 99.2% concordance of Aptima HPV results from GAA-treated and mock-treated specimens was noted. This result differed from the concordance result derived from Cervista (91.5%; P < 0.0002). Of the initially positive Cervista results, 21.9% reverted to negative following GAA treatment; the correlate value was 2.7% for Aptima HPV (P ‫؍‬ 0.01). While deleterious effects of GAA treatment on genomic DNA were noted with Cervista (P ‫؍‬ 0.0015), GAA treatment had no significant effects on Aptima HPV specimen signal/cutoff ratios or amplification of internal control RNA (P > 0.07). The validity of an Aptima HPV result is independent of GAA treatment and routine automated cytology processing. D etection of high-risk human papillomavirus (HPV) E6/E7transcripts is a recent diagnostic advancement in the context of cervical cancer triage. Transcription-mediated amplification (TMA) of these targets (Aptima HPV; Hologic/Gen-Probe, San Diego, CA) performs in an equivalent fashion to high-risk HPV DNA hybridization assays, such as the Digene HC2 high-risk HPV DNA test (Qiagen, Gaithersburg, MD) (1-4) and the Cervista HPV HR (Cervista; Hologic, Madison, WI) (5), for the detection of indolent cervical intraepithelial neoplasia (CIN) 2ϩ. The aforementioned studies also document improved specificity of Aptima HPV over that of DNA hybridization in the context of atypical squamous cells of undetermined significance (ASC-US) or nonsignificant cytology diagnoses and in cases of non-CIN 2ϩ biopsy results.Aptima HPV is an FDA-cleared assay for the analysis of liquidbased cytology collections (ThinPrep; Hologic, Marlborough, MA) on high-throughput instrumentation such as the Tigris DTS system (6). Past package insert guidelines have referred to meticulous and costly cross-contamination mitigation steps required when the ThinPrep vials are subjected to automated cytology processing prior to HPV detection (7). In addition, specimen car...

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“…A few studies, typically focused on hybrid capture technology (H c 2; Qiagen/Digene, Gaithersburg, MD), have been conflicting on the potential effect of GAA on HPV DNA detection (1,6). In addition to oligonucleotide probes specific for 14 high-risk HPV types (provided in three reagent mixtures), the Cervista HPV HR (Hologic/Third Wave Technologies, Madison, WI) possesses an oligonucleotide probe to assess relative DNA content.…”

mentioning

confidence: 99%

“…While this paradigm has procured a high percentage of newly satisfactory Pap smear analyses and has increased detection of significant gynecological lesions (1,2,6,11), recent data have revealed that GAA treatment increases false-positive diagnoses of atypical endocervical cells (3). A few studies, typically focused on hybrid capture technology (H c 2; Qiagen/Digene, Gaithersburg, MD), have been conflicting on the potential effect of GAA on HPV DNA detection (1,6).…”

mentioning

confidence: 99%

Effect of Glacial Acetic Acid Treatment of Liquid-Based Cytology Collections on Performance of Cervista HPV HR for Detection of High-Risk Human Papillomavirus

Munson

Chateau²,

Nelson

et al. 2012

J Clin Microbiol

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cInadequate cervical cytological analysis can be facilitated by glacial acetic acid (GAA) treatment of primary liquid-based collections to remove mucus, erythrocytes, inflammatory cells, and cellular debris. In the context of a commercial human papillomavirus (HPV) hybridization assay performed on 465 tandem specimens with and without GAA treatment, we show that GAA treatment significantly reduces genomic DNA content (P < 0.0001) and creates an increased potential for indeterminate and falsenegative results. In the context of cytological workflow, laboratories should consider providing a specimen aliquot for HPV DNA detection prior to GAA treatment. Molecular diagnostic assays specific for human papillomavirus (HPV) play a significant role in cervical cancer triage (15). Such assays, shown to have Ն98.9% negative predictive value for the underlying presence of cervical intraepithelial neoplasia 2ϩ (5, 13), can be performed on endocervical scrapings preserved in liquid transport medium. This collection, also forwarded for cytological analysis, has the potential to possess insufficient squamous cellularity, as well as abundant erythrocytes, mucus, acute inflammatory cells, and cytological debris (11). In particular, the latter factors may compromise Papanicolaou (Pap) smear analyses that are reliant on filter-based processing protocols (e.g., ThinPrep; Hologic, Marlborough, MA). As a result, glacial acetic acid (GAA)-based protocols have been developed to augment diagnostic yield, with some receiving U.S. Food and Drug Administration approval (4).While this paradigm has procured a high percentage of newly satisfactory Pap smear analyses and has increased detection of significant gynecological lesions (1, 2, 6, 11), recent data have revealed that GAA treatment increases false-positive diagnoses of atypical endocervical cells (3). A few studies, typically focused on hybrid capture technology (H c 2; Qiagen/Digene, Gaithersburg, MD), have been conflicting on the potential effect of GAA on HPV DNA detection (1, 6). In addition to oligonucleotide probes specific for 14 high-risk HPV types (provided in three reagent mixtures), the Cervista HPV HR (Hologic/Third Wave Technologies, Madison, WI) possesses an oligonucleotide probe to assess relative DNA content. The presented study utilizes this internal control as one means of assessing interference potential of GAA treatment on assay performance.In an institutional review board-approved protocol, 465 ThinPrep specimens were collected by two laboratories. These specimens were initially defined as unsatisfactory on the basis of the 2001 Bethesda system guidelines (12) for assessing quality of Pap smears. Laboratory A subjected unsatisfactory ThinPrep specimens to a manufacturer-advocated protocol in which unsatisfactory specimens were initially treated with a titration of GAA and CytoLyt solution (Hologic) (2, 4). In contrast, laboratory B validated a protocol derived from the reports of Iverson and Armour (8) and Agoff et al. (1) in which concentrated GAA was added to spec...

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Reflex high-risk human papillomavirus DNA testing (Hybrid Capture 2) of bloody ThinPrep specimens with atypical squamous cells of undetermined significance interpretation

Abstract: The pretreatment of bloody specimens with GAA did not appear to significantly affect high-risk HPV DNA testing in specimens with an ASCUS interpretation.

Cited by 14 publications

References 21 publications

Factors contributing to high ThinPrep® Pap test unsatisfactory rates in an academic medical center laboratory

Factors contributing to high ThinPrep® Pap test unsatisfactory rates in an academic medical center laboratory

Effect of Preanalytical Processing of ThinPrep Specimens on Detection of High-Risk Human Papillomavirus by the Aptima HPV Assay

Effect of Glacial Acetic Acid Treatment of Liquid-Based Cytology Collections on Performance of Cervista HPV HR for Detection of High-Risk Human Papillomavirus

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