Cervista HPV Research Articles

Evaluation of multiple screening methods for cervical cancers in rural areas of Xinjiang, China.

This study is to evaluate the screening methods of cervical cancers for rural females in Kash bachu, Xinjiang, China.A total number of 3000 married females were surveyed, and subjected to the gynecological examination. In these subjects, 1993 females received the careHPV (human papillomavirus) test, while 1007 females underwent the visual inspection with acetic acid (VIA) and visual inspection with Lugol's iodine (VILI). The subjects positive for careHPV detection were subjected to Cervista, Cobas 4800, and Aptima HPV detection, and Thinprep Cytologic Test (TCT). The subjects positive for 1 detection only received colposcopy cervical biopsy.A total of 569 subjects received the cervical biopsy, and the positive rate was 2.3% (69/3000), while the detection rate for CIN (cervical intraepithelial neoplasia) II and above levels was 1.13% (34/3000). Receiver operator characteristic (ROC) curve analysis showed that, the area under the curve (AUC) value for the careHPV test was 0.671, which was higher than the VIA/VILI (0.619), suggesting higher diagnostic value for the careHPV test. For the Cervista, Cobas 4800, Aptima HPV detection, and TCT methods, the highest AUC value was observed for the TCT method, indicating that the TCT method is the most valuable for the cervical cancer screening.The diagnostic value of careHPV test is superior to the VIA/VILA detection method. The TCT method has the greatest value for the cervical cancer screening. The Cervista HPV detection method should be considered where the conditions are limited.

Comparison of Cobas HPV with Cervista HPV Testing Assays to Detect High-risk HPV in Anal Pap Cytology Specimens

Comparison of Cobas HPV with Cervista HPV Testing Assays to Detect High-risk HPV in Anal Pap Cytology Specimens

Increased proportions of HIV-infected women met cervical cancer screening guideline in 2016

BackgroundHIV-infected women are five times more likely to develop invasive cervical cancer. Routine screening can detect early signs of cancer and provide an opportunity for treatment. However, suboptimal screening rates are reported in this population. This retrospective study examined the rates of cervical cancer screening in HIV-positive women, conducted according to the current guidelines, from 2014 to 2016 in an inner-city clinic.Materials and methodsWe implemented focused scheduling for eligible women by a designated medical assistant. Testing was conducted using Thin Prep™ and Cervista HPV HR™. Chi-square tests and logistic regression models were used to assess predictors of cervical cancer screening in 2016.ResultsA total of 360 adult HIV-infected women were active in medical care, as of December 31, 2016. Most were African American (77%) and aged 51–60 years (38%). In 2016, 75% of women met the guidelines for cervical cancer screening, compared to 48% in 2014. There was a significant association between receipt of cervical cancer screening in the prior 3 years and screening in 2016. In an adjusted model, those with a prior screening were 6.88 times (95% CI, 3.47–13.67) more likely to be screened in 2016, compared to those who were never previously screened.ConclusionFocused scheduling and implementation of the updated cervical cancer screening guideline extending the period of rescreening, after 3 yearly negative results or negative Papanicolaou/human papilloma virus testing, resulted in an increased proportion of women meeting the current guideline.

Cervista HPV 16/18 and HPV HR assays can be used in tissue specimens of oropharyngeal squamous carcinoma patients to determine high-risk HPV status

Cervista HPV 16/18 and HPV HR assays can be used in tissue specimens of oropharyngeal squamous carcinoma patients to determine high-risk HPV status

Maximizing the adequacy of Hologic(®) Cervista(®) HPV HR results on ThinPrep(®) Pap samples treated with glacial acetic acid.

Although glacial acetic acid (GAA) treatment of bloody cervical samples has reduced the rate of unsatisfactory Pap Tests, recent studies suggest that it may negatively impact high-risk (hr)-HPV test results. The objectives of this study were to compare the levels of genomic DNA between GAA treated and nontreated ThinPrep(®) samples using the Hologic(®) Cervista(®) HPV-HR assay and to compare the adequacy of the ThinPrep(®) Pap Test between aliquoted and nonaliquoted samples. Prior to GAA treatment, 2.5 ml of the cervical sample was prealiquoted from 102 bloody ThinPrep(®) vials. Both GAA treated and nontreated samples were analyzed for hr-HPV using the Cervista(®) HPV HR assay. The levels of genomic DNA were measured and compared between these samples. In addition, ThinPrep(®) Pap Test adequacy rates were calculated and compared on aliquoted and nonaliquoted cervical samples. Of the 102 cervical samples, 95 (93%) nontreated aliquots contained satisfactory levels of genomic DNA as compared to 36 (35%) GAA-treated samples (p < 0.00001). Ninety-nine (97%) aliquoted cervical samples were satisfactory for cytologic evaluation as compared to 1,326 (96%) GAA treated samples from 2013 (nonaliquoted); not statistically significant (p = 0.7968). The levels of genomic DNA were significantly decreased in GAA treated vs non-treated TP samples. Aliquoting from the TP sample prior to treatment with GAA enables accurate measurement of DNA without affecting the adequacy of the TP cytology slide.

Clinical Performance of Cervista HPV HR and HC2 Co-testing with SurePath Pap Cytology

Clinical Performance of Cervista HPV HR and HC2 Co-testing with SurePath Pap Cytology

Evaluation of The Cervista HPV A9 group In Screening Patients for Cervical Cancer.

To exploit the prevalence of HPV genotypes 52/58 in a Chinese population, we evaluated algorithms that the use the Cervista Assay A9 group for primary cervical cancer screening. The SHENCCAST II trial database was re-analyzed, focussing on the A9 pool of the Cervista HR-HPV Assay. Results for the detection CIN2+ and CIN3+ were correlated with a genotyping assay (MALDI-TOF) and cervical cytology to explore various screening algorithms. This analysis included 8,556 women with a mean age of 38.9. CIN 2+ rates were 2.7% (233/8556); CIN 3+ rates were 1.7% (141/8556). Overall HPV infection rates were 11.1% (950/8556) for Cervista, in which A5/A6, A7 and A9 groups were 26.5% (227/950), 22.9% (218/950) and 67.8% (644/950), respectively. The HPV A9 group is highly predictive of high-grade cervical lesions (CIN2+ OR = 103.61, CIN3+ OR = 128.059). Sensitivity and specificity for Cervista A9 group for CIN 2+ was 85.4% and 94.7%, and for CIN 3+ 89.4% and 93.8% respectively. Cervista A9 Assay followed by triage cytology for non-A9 positives has sensitivity and specificity for CIN2+ of 91.5% of 93.5%, and for CIN 3+ 94.3% and 92.6%. Using the Cervista A9 as the primary screen instead of the full Cervista assay, the percentage referred to colposcopy would decrease from 11.1% to 8.8% and percentage requiring cytology would decrease from 11.1% to 3.6%. Sensitivity of detecting CIN 2+(91.5%), CIN3+(94.3%) would remain similar to the complete Cervista HR-HPV assay for CIN 2+(93.1%), CIN3+(95.0%).

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off.

BackgroundHigh-risk human papillomavirus (HR HPV) testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.MethodsWe report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology (LBC) samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2) in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.ResultsThe overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8). Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia (CIN3+) were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.ConclusionsPerformance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0674-1) contains supplementary material, which is available to authorized users.

Analytical performance of cervista HPV 16/18 in SurePath pap specimens.

To evaluate the performance of Cervista HPV 16/18 in SurePath specimens, we compared the analytical sensitivity of Cervista HPV 16/18 with that of a previously validated PCR-based, commercially available HPV genotyping assay, EasyChip HPV Blot, in residual specimens collected after routine Pap tests at our cancer center. We retrospectively selected 79 consecutive Cervista HPV HR (high risk)-positive SurePath residual Pap specimens. The cytology results for these specimens comprised 42 negative, 22 ASC-US/ASC-H, 10 low-grade squamous intraepithelial lesions, and 5 high-grade squamous intraepithelial lesions. HPV 16/18 genotypes of the 79 specimens were analyzed by Cervista HPV 16/18 assay and EasyChip genotyping assay and compared with the patient's follow-up results. Of the 79 cases, 33 (42%) were positive for HPV16/18 by Cervista HPV 16/18 and 37 (47%) were positive by EasyChip. The overall agreement between the 2 assays, at 85% (67/79), was good (kappa = 0.698, 95% CI: 0.541-0.855). In the 65 patients with follow-up results, the sensitivity for predicting cervical intraepithelial neoplasia grade 2 or higher (CIN2+) was 77% for Cervista HPV 16/18 assay and 69% for EasyChip. The predictive values for CIN2+ in cases stratified by Pap results were highly consistent between the Cervista HPV16/18 and EasyChip assays; there was one false negative HPV16 result, in a specimen identified as NILM by EasyChip. Our findings support use of the Cervista HPV 16/18 assay for HPV16/18 genotyping in SurePath Pap specimens. However, further studies of larger cohorts with clinical follow-up data are required to verify the efficacy of Cervista HPV16/18 assay in SurePath Pap specimens.

Triage of Women With Negative Cytology and Positive High-Risk HPV

To determine a management strategy for women testing negative with cervical cytology and positive for high-risk human papillomavirus (HR-HPV). Using the data from the large population-based Shenzhen Cervical Cancer Screening Trials II and III (SHENCCAST II/III), we compared the risk for cervical intraepithelial neoplasia grade 3 or cancer (CIN 3+) in women with negative cytology but testing positive for HR-HPV DNA using Cervista HPV HR or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF), followed by secondary screening with type-specific Cervista HPV-16/18 or MALDI-TOF. The study aim was to seek the most sensitive and specific triage assay for referral for colposcopy. A total of 8,556 women had complete data. The proportion of women with negative cytology and positive HR-HPV by Cervista HR-HPV (5.30%, 453/8,556) was slightly lower than that of women with negative cytology and HR-HPV-positive tests by MALDI-TOF (5.82%, 499/8,556, p = .015). The proportion of women having negative cervical cytology and a positive HR-HPV by Cervista HR who have HPV-16 and/or -18 by Cervista HPV-16/18 (11.8%, 53/448) was less than that of women with a negative cervical cytology and positive HR-HPV by MALDI-TOF who have HPV-16 and/or -18 by MALDI-TOF (19.4%, 97/499, p = .001). The proportion of CIN 3+ within negative cervical cytology and positive HR-HPV that were HPV-16 and/or -18 for the Cervista 16/18 assay (61.5%, 8/13) was similar to that for the MALDI-TOF 16/18 assay (66.7%, 10/15, p = 0.8). In the cytology-negative HR-HPV-positive population, Cervista 16/18 as the HPV detection method would refer 11.8% of women for colposcopy and diagnose 61.5% of the CIN 3+, while MALDI-TOF16/18 would refer 19.4% and diagnose 66.7% of the CIN 3+. Cervista HPV-16/18 seems to be the superior triage test. However, in resource-limited settings, an assay that includes 16/18 genotyping in the primary result (rather than a second test) may be more cost efficient.

Comparison of Commercial Hybridization and Automated Transcription-Mediated Amplification Modalities for Detection of High-Risk Human Papillomavirus Nucleic Acid

Assessment of 4,056 cytology collections by Cervista HPV HR and APTIMA HPV yielded 88.7% concordance, with increased detection by Cervista in patients with atypical squamous cells of undetermined significance (ASC-US) and patients negative for intraepithelial lesions and malignancy (NILM) (P ≤ 0.02). Both assays detected ≥91.7% of cervical intraepithelial neoplasia grade 2+ (CIN2+) lesions. A total of 262 specimens demonstrated luminescence within all three Cervista oligonucleotide mixtures (triple positive). APTIMA HPV and PCR-based microarray confirmed triple-positive results at rates of 7.3% and 5.9%, respectively.

High-Risk Human Papillomavirus Detection in Women With Low-Grade Squamous Intraepithelial Lesions or Higher-Grade Cytology Using the Cervista HPV HR Test

High-risk human papillomavirus (HR-HPV) persistence is thought to be necessary for the development of cervical cancer. Because not all cases of low-grade squamous intraepithelial lesion (LSIL) or higher-grade squamous intraepithelial lesion are associated with HR-HPV, detection of HR-HPV in women with these cervical abnormalities may be clinically useful for management. The aim of this study was to detect HR-HPV in women with LSIL or higher-grade cytology. In a multicenter, prospective clinical study, residual liquid-based cytological specimens from 3,966 US women were analyzed. Women with LSIL or higher-grade cytology underwent colposcopy and cervical biopsy as clinically indicated. The test was used to detect HR-HPV in women with cytologically diagnosed LSIL or higher, with histological confirmation of cervical intraepithelial neoplasia 2 (CIN 2) or worse by a central review panel. Among subjects with LSIL or higher-grade cytology and complete data sets, 11.8% (41/347) were diagnosed with CIN 2 or worse; 82.1% (285/347) were HR-HPV positive. The prevalence of CIN 2 or worse and CIN 3 or worse was 14.4% (41/285) and 7.0% (20/285), respectively, among subjects who were HR-HPV positive. All subjects diagnosed with CIN 2 or worse (41/41) and CIN 3 or worse (20/20) tested positive for HR-HPV. Sensitivity and negative predictive value calculated for CIN 2 or worse were 100% (95% CI = 91.4%-100.0%) and 100% (95% CI = 94.2%-100.0%), respectively. Specificity and positive predictive value among these subjects were 20.3% (95% CI = 16.1%-25.1%) and 14.4% (95% CI = 10.8%-18.9%), respectively. Detection of HR-HPV in women with LSIL or higher-grade cytology using the HPV HR test may allow clinicians to further triage women for advanced clinical management.

Cervista HPV HR Test Kit in Cervical Cancer Screening

Wiwanitkit House, Bangkhae, Bangkok, Thailand Hainan Medical University, Haikou, China University of Nis, Nis, Serbia Joseph Ayobabalola University, Ikeji Arakeji, Osun State, Nigeria [email protected]

Validation of Cervista HPV HR and Cervista HPV16/18 Assays in Head and Neck FNA Specimens from Patients with Oropharyngeal Carcinoma

Validation of Cervista HPV HR and Cervista HPV16/18 Assays in Head and Neck FNA Specimens from Patients with Oropharyngeal Carcinoma

Cervista HPV HR and HPV16/18 Assays in Head and Neck FNA Specimens, a Valid Option of HPV Testing, Compared with HPV In Situ Hybridization/p16 Immunostaining Assays in Tissue Specimens from Patients with Oropharyngeal Carcinoma

Cervista HPV HR and HPV16/18 Assays in Head and Neck FNA Specimens, a Valid Option of HPV Testing, Compared with HPV In Situ Hybridization/p16 Immunostaining Assays in Tissue Specimens from Patients with Oropharyngeal Carcinoma

Clinical Experience with the Cervista HPV HR Assay: Correlation of Cytology and HPV Status from 56,501 Specimens

Clinical Experience with the Cervista HPV HR Assay: Correlation of Cytology and HPV Status from 56,501 Specimens

Patient Safety and the Next Generation of HPV DNA TestsThe Authors’ ReplyPostscript

The article by Kinney et al1 in the August 2010 issue of the Journal expressed concern about the approval by the US Food and Drug Administration (FDA) of the Cervista HPV HR (high-risk human papillomavirus) test (Third Wave Technologies, Madison, WI; now owned by Hologic, Bedford, MA) and questioned the safety of the device owing to the positivity rate seen in the study population for women 30 years and older with negative cytologic findings (NILM ≥30). The clinical cutoff for the Cervista HPV HR test was set in the same manner as for the only other FDA-approved HR-HPV test, Hybrid Capture 2 (HC2; Qiagen, Gaithersburg, MD), by evaluating clinical sensitivity and specificity in the population with atypical squamous cells of undetermined significance (ASC-US). The rationale for this approach is that the ASC-US population, as a population with equivocal cytologic findings, provides an informative profile of how an HPV test performs in an intended-use population in which disease prevalence is sufficient for characterizing a clinical cutoff and disease end points can be readily assessed. A head-to-head comparison against the HC2 test was performed during review of the Cervista HPV HR device. This evaluation revealed equivalent clinical specificity for cervical intraepithelial neoplasia (CIN) 2 or worse for the 2 tests in the Cervista ASC-US data set, and the Cervista HPV HR test detected 100% of cases of CIN 3 or worse. In determining whether an in vitro diagnostic device is safe and effective, the FDA must consider whether the probable benefits of using the device outweigh the probable risks when the device is used in accordance with its approved labeling. Per current screening guidelines,2 the predominant use of HPV testing in the NILM ≥30 population is to extend cervical cancer screening intervals in HPV– women. In a worst-case scenario in …

High-risk human papilloma virus DNA detection Kit(cervista HPV HR)should be highly validated clinically in cervical cancer screening programs

The aim of this study is to evaluate the clinical significance of High-risk Human Papilloma virus DNA Detection Kit (Cervista HPV HR) designed to the utilized in cervical cancer screening programs. The investigation for Cervista HPV HR test is designed to detect 437 residual liquid-based cytology specimens collected during routine liquid-based Pap tests at standard care vistis and to identify the presence of HR HPV. We compared Cervista HPV HR Test against standard PCR, in order to examine the performance of Cervista HPV HR Test in populations with cervical intraepithelial neoplasia grade 2+ (CIN 2, CIN 3 and Cancer, CIN 2+), and the capabilities of A5/A6, A7, A9 oligonucleotides of Cervista for predicting CIN2+. The accuracy of Cervista compared to PCR with bi-directional sequencing was 88.26%. The positive percent of Cervista HPV HR Test and PCR were 38.96% and 29.08%, respectively. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of Cervista HPV HR Test for the detection of CIN2+ were 98.46%, 58.49%, 99.54% and 29.68%, respectively. The A9 oligonucleotides positivity percent was significantly higher in CIN2 + (odds ratio: 24.037, 95% CI: 10.086 - 57.283). The Cervista HPV HR test can be clinically used for detecting HR HPV types during routine cervical cancer screening. A9 oligonucleotides were also strongly associated with CIN2+ diagnosis, which is improtant in cervical cancer screening for triage to colposcopy.

Use of Cervista HPV HR assay for detection of human papillomavirus in samples with hybrid capture borderline negative results

We have evaluated Cervista HPV HR for papillomavirus detection in 65 samples previously borderline negative by the hybrid capture method (Digene), using InnoLipa and sequencing as confirmatory techniques. Nine samples were found to be positive by Cervista HPV HR, of which five (7.6%) were confirmed by InnoLipa. Four samples (6.1%) were false positive, of which three samples were reactive for A9 probes. The Cervista HPV HR assay can detect HPV-positive samples from those with hybrid capture borderline results but can produce false-positive results when tested for reactivity with A9 probes.

Comparison of methods trial for high‐risk HPV

In efforts to improve service, we compared the performance of four methods of HPV detection: Invader HPV (Hologic), Hybrid Capture 2 (Qiagen), Inform HPV detection (Ventana), and standard PCR.Using blinded/de-identified cervical samples in Preservcyt (Hologic), we compared Ventana's Inform HPV Test, against Hologic's HPV Invader and PCR. In a separate evaluation, we compared Inform versus Invader versus hc2. Ventana employs in situ hybridization; Hologic's technology uses three specifically designed oligonucleotides and a fluorescent signal for detection. Qiagen's hc2 method incorporates enzyme-linked antibody detection of RNA-DNA hybrids. PCR testing was provided by Access Genetics (Minneapolis, MN). The United States Food and Drug Administration recently approved the Third Wave/Hologic Invader HPV high-risk test (rebranded as Cervista HPV HR Test).In this small study, involving a few hundred tests, Third Wave, Qiagen, and PCR tests were comparable. Kappa statistics comparing Third Wave to PCR and Third Wave to Qiagen were 0.88 and 0.74, respectively. Ventana's method did not correlate well with any of the other methods with Kappa's ranging from a low of 0.25 versus Qiagen to 0.31 versus PCR. Kappa statistics measure correlation and not accuracy of measurement.Although we felt that the specificity of our original HPV method, Ventana Inform was satisfactory and lowered our subsequent colposcopy rate, worries about its lower sensitivity caused us to look at other techniques. Other methods, PCR, hc2, and Invader, appeared comparable with one another in our series. We chose to implement the Third Wave test in our laboratory.