Clinical laboratory evaluation of Invader® chemistry and hybrid capture for detection of high-risk human papillomavirus in liquid-based cytology specimens

Munson, Erik; Chateau, Brian K. Du; Bellerose, Bronya; Czarnecka, Jolanta; Griep, Judy

doi:10.1016/j.diagmicrobio.2011.07.004

Cited by 8 publications

(10 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Other studies published from a laboratory (2)(3)(4)(5)(6) or clinical (7) perspective do not reflect this opinion. In this letter, we compare a large data set generated from consecutive 9-month intervals of HC2 and Cervista screening, stratified by age and cytological classification.…”

mentioning

confidence: 94%

See 1 more Smart Citation

Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data

2013

Self Cite

View full text Add to dashboard Cite

mentioning

confidence: 94%

“…Beginning in July 2009, highrisk HPV detection was performed by Wheaton Franciscan Laboratory utilizing Cervista according to the package insert protocol (6,8). In an institutional review board-approved protocol, an 18-month review of all HPV screenings was executed (October 2008 through March 2010).…”

mentioning

confidence: 99%

Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data

2013

Self Cite

View full text Add to dashboard Cite

“…Two-milliliter ThinPrep aliquots were subjected to a previously described paramagnetic-based DNA extraction and HPV-specific Invader-based hybridization (14). In brief, luminescence-labeled oligonucleotides specific for DNA of high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 were incubated with DNA extracts for 4 h at 62°C.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2014

Self Cite

View full text Add to dashboard Cite

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...

show abstract

“…Performance of the Cervista HPV HR has been shown to be largely equivalent to that of H c 2, both from laboratory (7,9,10,14) and clinical (5) perspectives. However, few studies have analyzed the performance of these assays on ThinPrep collections treated with GAA.…”

mentioning

confidence: 99%

“…Assay performance, including manual Agencourt-based paramagnetic extraction (10), and results interpretation were executed per the package insert. Relative genomic DNA content (gDNA), as determined by human-histone-specific oligonucleotide hybridization, was required to equal or exceed a 1.5 fluorescence ratio to background for valid analysis.…”

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

Self Cite

View full text Add to dashboard Cite

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...

show abstract

Clinical laboratory evaluation of Invader® chemistry and hybrid capture for detection of high-risk human papillomavirus in liquid-based cytology specimens

Cited by 8 publications

References 23 publications

Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data

Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data

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

Contact Info

Product

Resources

About