Comparison of the Hybrid Capture 2 and cobas 4800 Tests for Detection of High-Risk Human Papillomavirus in Specimens Collected in PreservCyt Medium

Wong, Anita; Fuller, Jeff; Pabbaraju, Kanti; Wong, Sallene; Zahariadis, George

doi:10.1128/jcm.05400-11

Cited by 41 publications

(37 citation statements)

References 31 publications

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“…Since HC2 is the most commonly used HPV test and recommended as a standard, we included this test at baseline with cobas 4800 HPV testing simply to obtain comparative data. The agreement of 85.1% that we observed, although at a lower range of reported agreements, was still consistent with the overall published data (11)(12)(13)(14)(15)(16). However, as the study utilized pooled samples, no cytology or histology results could be obtained to correlate with the above-described HPV testing results.…”

Section: Stability Of Cervical Specimenssupporting

confidence: 80%

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

Gilbert¹,

Oates²,

Ratnam

2013

J Clin Microbiol

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Section: Stability Of Cervical Specimenssupporting

confidence: 80%

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

Gilbert¹,

Oates²,

Ratnam

2013

J Clin Microbiol

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“…In addition, the Cobas HPV test demonstrated a sensitivity (91.7%) and specificity (97.0%) between those of the other two assays. In recently published studies, Cobas HPV also showed comparable performances to HC2, with kappa coefficients from 0.69 to 0.87, but there also were discrepant results between HC2 and Cobas HPV in approximately 6% to 15% of the samples (10,20,34). In another recent study, Cobas HPV showed a clinical sensitivity of 89.7% and a specificity of 66.7% for detecting cases with CIN2 or worse-grade CINs, whereas HC2 demonstrated a better clinical sensitivity of 93.1% and a specificity of 72.2% (18).…”

Section: Discussionmentioning

confidence: 99%

“…Among them, the Abbott RealTime HR HPV assay was introduced to clinical laboratories, demonstrating performances comparable with those of HC2 (4,16,24,33). In April 2011, the Roche Cobas HPV assay, which also utilizes the real-time PCR principle, was approved by the U.S. FDA for detecting HR HPVs, and a few studies compared the results obtained by Cobas HPV with those of HC2 (10,20,34). However, there are currently no published studies in the literature which concurrently evaluated HC2, RealTime HR, and Cobas HPV assays.…”

mentioning

confidence: 99%

Comparison of the Abbott RealTi m e High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 Assays to Direct Sequencing and Genotyping of HPV DNA

et al. 2012

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bInfection with high-risk (HR) human papillomavirus (HPV) genotypes is an important risk factor for cervical cancers. We evaluated the clinical performances of two new real-time PCR assays for detecting HR HPVs compared to that of the Hybrid Capture 2 test (HC2). A total of 356 cervical swab specimens, which had been examined for cervical cytology, were assayed by Abbott RealTime HR and Roche Cobas HPV as well as HC2. Sensitivities and specificities of these assays were determined based on the criteria that concordant results among the three assays were regarded as true-positive or -negative and that the results of genotyping and sequencing were considered true findings when the HPV assays presented discrepant results. The overall concordance rate among the results for the three assays was 82.6%, and RealTime HR and Cobas HPV assays agreed with HC2 in 86.1% and 89.9% of cases, respectively. The two real-time PCR assays agreed with each other for 89.6% of the samples, and the concordance rate between them was equal to or greater than 98.0% for detecting HPV type 16 or 18. HC2 demonstrated a sensitivity of 96.6% with a specificity of 89.1% for detecting HR HPVs, while RealTime HR presented a sensitivity of 78.3% with a specificity of 99.2%. The sensitivity and specificity of Cobas HPV for detecting HR HPVs were 91.7% and 97.0%. The new real-time PCR assays exhibited lower sensitivities for detecting HR HPVs than that of HC2. Nevertheless, the newly introduced assays have an advantage of simultaneously identifying HPV types 16 and 18 from clinical samples. P ersistent cervical infection of human papillomavirus (HPV) is a well-known risk factor for developing cervical cancer, which is the second most common malignancy in women, causing approximately 250,000 deaths each year worldwide (35, 36). More than 150 HPV genotypes have been identified, and approximately 50 of them are known to infect cervical epithelia. Recently, the International Agency for Research on Cancer (IARC) defined 12 high-risk (HR) HPV genotypes (HPV types 16,18,31,33,35, 39, 45, 51, 52, 56, 58, and 59) as group 1 carcinogens (3). In particular, HPV16 is known as the most common HPV type, contributing to approximately half of all invasive cervical cancer cases. This genotype is also known to demonstrate a biological advantage in transmission, persistence, and transformation (2). HPV18 has been reported as the second most common cause of HPV-associated invasive cervical cancers, and the proportion of cervical cancers related to HPV16 and/or HPV18 has been reported to be between 68% and 82% (19).Morphological examination of cervix cytology has been used as a screening test for the prevention and early detection of cervical cancers over the past 50 years (12, 13). A major target of the cervical screening is to detect cases of cervical intraepithelial neoplasia grade 3 (CIN3), which can be treated before it progresses to invasive cancer. However, cytology tests are limited in predicting HPV infections and cervical cancers. Abnormal findings in cervic...

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“…However, the cobas® Test also detects genotype 66 and indicates specifically whether the specimen is positive or negative for HPV-16 or HPV-18. 55 The strong association of cervical cancer with these two genotypes is the basis for a primary HPV screening strategy in which women who test positive for HPV-16/HPV-18+ genotypes are triaged directly for colposcopy. In ATHENA, genotyping for HPV-16/HPV-18 improved the sensitivity for CIN3+ and required far fewer cytology tests with only a marginal increase in colposcopies over co-testing.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

et al. 2016

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BACKGROUND: Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies. MAIN METHODS: Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had cotesting. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+). KEY RESULTS: The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected. CONCLUSIONS: Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

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Comparison of the Hybrid Capture 2 and cobas 4800 Tests for Detection of High-Risk Human Papillomavirus in Specimens Collected in PreservCyt Medium

Cited by 41 publications

References 31 publications

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

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

Comparison of the Abbott RealTi m e High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 Assays to Direct Sequencing and Genotyping of HPV DNA

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

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