Stability of Cervical Specimens in SurePath Medium for Human Papillomavirus Testing with the Roche cobas 4800 Assay

Gilbert, Laura; Oates, Elizabeth; Ratnam, Samuel

doi:10.1128/jcm.01391-13

Cited by 11 publications

(12 citation statements)

References 14 publications

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“…Except for Clart, the rest of the assays have been FDA-approved for screening as reliable and high throughput solutions [19,21,22]. It is important to note that the preservative fluid, storage time, and additional long-term preservatives have an impact on the reliability of the results [20]. In our opinion, performing p16/Ki-67 dual staining tests is useful, even crucial, for the correct categorization of hrHPV-positive patients with unequivocal cytological report, especially LSIL, ASC-US, or ASC-H. Barron et al published a paper devoted to triaging LSIL-H (ASC-H) using hrHPV typing.…”

Section: Discussionmentioning

confidence: 99%

“…To reach high detection rate of HSIL, in many papers, a lot of effort has been devoted to quality control and reproducibility of molecular solutions used for HPV typing. Conclusions were mostly similar: keeping full validation from the stage of sampling through storage, adequate equipment, and analysis are crucial [19][20][21][22]. However, the relatively high-cost of testing (roughly 40 USD per singular DNA-HPV or singular p16/Ki-67 test) was pointed out and a national screening provider should face new reality by employing such modern techniques.…”

Section: Introductionmentioning

confidence: 98%

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HPV genotyping and p16/Ki-67 test significantly improve detection rate of high-grade cervical squamous intraepithelial lesion

Lewitowicz¹,

Nasierowska‐Guttmejer²,

Rokitaⴕ³

et al. 2020

aoms

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Introduction: Liquid-based cytology allows to apply modern and specific analyses of hrHPV genotyping in p16/Ki-67 test. All of these together could raise accuracy ratio for high-grade squamous intraepithelial lesion above 90%. The purpose of this study was to evaluate the diagnostic accuracy of LBC, hrHPV testing, and p16/Ki-67 testing in diagnosis of high-grade cervical intraepithelial lesions. Material and methods: The study consisted of 176 women, out of which 50 presented with HSIL (CIN2) SCC (cervical intraepithelial lesion grade 2 squamous cell carcinoma). 126 women with a negative Pap test were pooled into the second group of the study. All patients were resampled for LBC, HPV genotyping, and for the p16/Ki-67 test. The research was carried out between May and December 2017, and second sampling were taken from 1 to 4 months. Results: We reported a strong correlation between positive Pap test and hrHPV (p < 0.05) that met accuracy close to 90%. We noted correlations between a positive p16/Ki-67 with a positive Pap test: p

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

HPV genotyping and p16/Ki-67 test significantly improve detection rate of high-grade cervical squamous intraepithelial lesion

Lewitowicz¹,

Nasierowska‐Guttmejer²,

Rokitaⴕ³

et al. 2020

aoms

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“…Since we used Surepath which includes a small amount of formalin for preservation [31]. Limited availability of RNAs from residual LBC samples is most likely due to a chemical linkage between proteins and RNAs generated by formalin [3233]. …”

Section: Discussionmentioning

confidence: 99%

Molecular Diagnosis Using Residual Liquid-Based Cytology Materials for Patients with Nondiagnostic or Indeterminate Thyroid Nodules

et al. 2016

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BackgroundMolecular analysis for common somatic mutations in thyroid cancer can improve diagnostic accuracy of fine-needle aspiration cytology (FNAC) in the nondiagnostic or indeterminate category of thyroid nodules. In this study, we evaluated the feasibility of molecular diagnosis from residual liquid-based cytology (LBC) material after cytological diagnosis.MethodsThis prospective study enrolled 53 patients with thyroid nodules diagnosed as nondiagnostic, atypia of undetermined significance (AUS), or follicular lesion of undetermined significance (FLUS) after FNAC. DNAs and RNAs were isolated from residual LBC materials. BRAFV600E and RAS point mutations, PAX8/peroxisome proliferator-activated receptor γ (PPARγ), RET/PTC1, and RET/PTC3 rearrangements were evaluated by real-time polymerase chain reaction and pyrosequencing.ResultsAll DNAs from 53 residual LBC samples could be analysed and point mutations were detected in 10 samples (19%). In 17 AUS nodules, seven samples (41%) had point mutations including BRAF (n=4), NRAS (n=2), and KRAS (n=1). In 20 FLUS nodules, three samples (15%) had NRAS point mutations. RNA from only one FLUS nodule could be analysed for rearrangements and there was no abnormality.ConclusionMolecular analysis for BRAF and RAS mutations was feasible in residual LBC materials and might be useful for diagnosis of indeterminate thyroid nodules.

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“…When the analysis was confined to samples with normal cytology and a presumed lower viral load, a higher concordance was seen in the SPPF samples refrigerated versus those held at ambient temperature. Likewise, Gilbert et al 15 compared cobas HPV test results in ambient versus refrigerated pooled samples collected in SPPF from a colposcopy referral population, and also treated a proportion of the ambient samples with the same preanalytic procedure reported herein. Overall, they saw high concordance of results across all groups.…”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Preanalytic Procedure for Performing the cobas HPV Test in SurePath Preservative Fluid

Krevolin

Hardy

Pane

et al. 2017

The Journal of Molecular Diagnostics

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The formation of chemical cross-links between nucleic acids and proteins in formalin-containing media presents challenges for human papillomavirus (HPV) testing of cervical samples collected in SurePath Preservative Fluid. A preanalytic process involving addition of a nucleophilic buffer and heating the sample to 120°C was developed to reverse the effects of cross-linking and improve nucleic acid accessibility for the cobas HPV Test in SurePath. Cycle threshold (C) values for cobas HPV detection were evaluated over time and various temperatures, and mean C differences between pretreated and both untreated SurePath samples and those collected in PreservCyt were assessed. Without pretreatment, low viral levels (1 × limit of detection) of HPV were no longer detectable by 7 days. For prospectively collected specimens, mean (95% CI) C differences between pretreated and untreated samples indicated enhanced HPV DNA recovery in all categories of treated samples: -2.58 (-3.16 to -2.01), -2.63 (-3.62 to -1.64), and -3.39 (-4.95 to -1.82), respectively, for other 12 high-risk HPV types, HPV16, and HPV18. Furthermore, mean (95% CI) C differences of pretreated SurePath samples were comparable to simultaneously collected PreservCyt samples: -0.48 (-0.98 to 0.02) and -0.23 (-0.93 to 0.46), respectively, for HPV16 and HPV18; a borderline significant difference [-0.35 (-0.57 to -0.13)] was observed for other 12 high-risk HPV types. This preanalytic procedure therefore ensures a validated, safe, and accurate method for cobas HPV testing in SurePath.

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Stability of Cervical Specimens in SurePath Medium for Human Papillomavirus Testing with the Roche cobas 4800 Assay

Cited by 11 publications

References 14 publications

HPV genotyping and p16/Ki-67 test significantly improve detection rate of high-grade cervical squamous intraepithelial lesion

HPV genotyping and p16/Ki-67 test significantly improve detection rate of high-grade cervical squamous intraepithelial lesion

Molecular Diagnosis Using Residual Liquid-Based Cytology Materials for Patients with Nondiagnostic or Indeterminate Thyroid Nodules

Development and Validation of a Preanalytic Procedure for Performing the cobas HPV Test in SurePath Preservative Fluid

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