Clinical performance of Abbott RealTime High Risk HPV test for detection of high-grade cervical intraepithelial neoplasia in women with abnormal cytology

Huang, Shihai; Erickson, Brian; Tang, Ning; Mak, Wai-Bing; Salituro, John; Robinson, John; Abravaya, Klara

doi:10.1016/s1386-6532(09)70004-6

Cited by 31 publications

(28 citation statements)

References 12 publications

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“…This assay also has been used as a reference test in many studies to evaluate newly developed HPV detection assays (11,21,(25)(26)(27)32). HPV detection assays utilizing the real-time PCR method have also been developed; these are able to produce results for HPV types 16 and 18 and other HR genotypes at once (5,15). Among them, the Abbott RealTime HR HPV assay was introduced to clinical laboratories, demonstrating performances comparable with those of HC2 (4,16,24,33).…”

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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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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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“…The clinical sensitivity and NPV of RealTime for CIN2+ lesions in all published studies were at least comparable with hc2, if not better. Clinical specificity and PPV for either CIN2+ or CIN3+ were similar between RealTime and hc2 in one study [70] and RealTime performed slightly better in another study [72]. To the authors' knowledge, more clinical specificity data on samples that originate from a population-based screening cohort are currently being generated; for example, data from a Slovenian national HPV prevalence study, which has already prospectively enrolled more than 4000 unselected women 20-64 years of age attending organized routine Pap screening, will be available in October 2010.…”

Section: Hr-hpv-dna-based Screening Assays With Concurrent Individualmentioning

confidence: 86%

“…In specimens obtained from women 30 years of age or older with normal cytology in a screening population, the HPV positivity rate was 6.5% (49 out of 757) [69]. In the second study, RealTime demonstrated similar clinical performance (sensitivity, specificity, PPV and NPV) for the detection of CIN2+ and CIN3+ when compared with hc2, in 702 patients with abnormal cytology referred to colposcopy [70]. The clinical sensitivity for detection of CIN2+ was shown to be 97.8% with RealTime and 95.6% with hc2, and for the detection of CIN3+ 100% with RealTime and 97% with hc2 [70].…”

Section: Hr-hpv-dna-based Screening Assays With Concurrent Individualmentioning

confidence: 87%

“…In the second study, RealTime demonstrated similar clinical performance (sensitivity, specificity, PPV and NPV) for the detection of CIN2+ and CIN3+ when compared with hc2, in 702 patients with abnormal cytology referred to colposcopy [70]. The clinical sensitivity for detection of CIN2+ was shown to be 97.8% with RealTime and 95.6% with hc2, and for the detection of CIN3+ 100% with RealTime and 97% with hc2 [70]. In the third study, our laboratory evaluated the clinical sensitivity of RealTime in comparison with hc2 on 95 and 267 archived routine cervical specimens collected in STM from women with histologically confirmed cervical carcinoma and CIN3 lesions, respectively [68].…”

Section: Hr-hpv-dna-based Screening Assays With Concurrent Individualmentioning

confidence: 89%

“…To the best of our knowledge, six studies have evaluated the clinical performance of RealTime on different patient populations to date [68][69][70][71][72][73]. In the first study, the clinical sensitivity of the RealTime test was evaluated in 593 archived cervical specimens from Amsterdam (The Netherlands) and the presence of hr-HPV was detected in 97.2% (246 out of 253) and 98.5% (335 out of 340) of CIN3 and cervical cancer specimens, respectively [69].…”

Section: Hr-hpv-dna-based Screening Assays With Concurrent Individualmentioning

confidence: 99%

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Clinical performance of Abbott RealTime High Risk HPV test for detection of high-grade cervical intraepithelial neoplasia in women with abnormal cytology

Cited by 31 publications

References 12 publications

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

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

Commercially available assays for multiplex detection of alpha human papillomaviruses

Human papillomavirus testing versus repeat cytology for triage of minor cytological cervical lesions

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