Comparison of Abbott RealTime High Risk HPV and Hybrid Capture 2 for the detection of high-risk HPV DNA in a referral population setting

Venturoli, Simona; Leo, Elisa; Nocera, Martina; Barbieri, Daniela; Cricca, Monica; Costa, Silvano; Santini, Donatella; Zerbini, Marialuisa

doi:10.1016/j.jcv.2011.10.016

Cited by 15 publications

(11 citation statements)

References 24 publications

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“…Manual preanalytical processing of LBC specimens is laborious, is time-consuming, and leaves room for labeling errors. We have evaluated a new worktable setup of the Tecan Freedom EVO system custom-configured to automate the preanalytic steps required to prepare cervical specimens collected in ThinPrep LBC vials for HR-HPV DNA testing with the Abbott RealTime High Risk HPV assay, which has been validated in both the triage of the referral population and primary cervical cancer screening [6][7][8] to assess the impact of automated versus manual preanalytics on assay performance and ease of use.…”

Section: Discussionmentioning

confidence: 99%

Improving Laboratory Efficiency by Automation of Preanalytic Processing of ThinPrep Specimens for Real-Time PCR High-Risk HPV Testing

Barbieri

Venturoli

Costa³

et al. 2016

SLAS Technology

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Cervical specimens collected in liquid-based cytology (LBC) media are the most common sample type used for high-risk human papillomavirus (HPV) testing. Since preanalytic steps such as vortexing and decapping vials, liquid transfer to a sample input tube with matching unique identifier, and recapping the original vials are required for processing LBC samples prior to running the Abbott RealTime High Risk HPV assay (Abbott, Wiesbaden, Germany), a full manual execution can be complicated, especially in high-throughput diagnostic contexts. Here, a custom-configured worktable setup for the Tecan Freedom EVO (Tecan, Männedorf, Switzerland) designed to automate and control preanalytic steps for ThinPrep (Hologic, Marlborough, MA) samples was used to evaluate the impact of automated versus manual preanalytics. Archival results for manual processing of 226 samples were compared with those obtained with the Tecan protocol, observing a very good overall concordance for final assay interpretation (95.6%). High overall agreement (100%) resulted also from retesting 99 samples by both the preanalytical protocols. High reproducibility was observed analyzing 23 randomly selected samples by automated preprocessing in triplicate. Hence, the new configuration of the Tecan platform translates the manual steps required to process ThinPrep specimens into automated operations, controls sample identification, and allows for saving hands-on time, while maintaining assay reproducibility and ensuring reliability of results, making it suitable for screening settings.

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Section: Discussionmentioning

confidence: 99%

Improving Laboratory Efficiency by Automation of Preanalytic Processing of ThinPrep Specimens for Real-Time PCR High-Risk HPV Testing

Barbieri

Venturoli

Costa³

et al. 2016

SLAS Technology

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“…The two real-time PCR assays are suggested by their respective manufacturers to be able to detect 14 HR HPV genotypes (HPV types 16,18,31,33,35,39,45, 51, 52, 56, 58, 59, 66, and 68). The results of the two assays are reported as either positive or negative for HPV types 16 and 18 and a pooled result for the remaining 12 HR genotypes.…”

Section: Methodsmentioning

confidence: 99%

“…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.…”

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confidence: 99%

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confidence: 99%

“…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). 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).…”

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confidence: 99%

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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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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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Human Papillomaviruses

Babady

2016

Manual of Commercial Methods in Clinical Microbiology

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Comparison of Abbott RealTime High Risk HPV and Hybrid Capture 2 for the detection of high-risk HPV DNA in a referral population setting

Cited by 15 publications

References 24 publications

Improving Laboratory Efficiency by Automation of Preanalytic Processing of ThinPrep Specimens for Real-Time PCR High-Risk HPV Testing

Improving Laboratory Efficiency by Automation of Preanalytic Processing of ThinPrep Specimens for Real-Time PCR High-Risk HPV Testing

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

Human Papillomaviruses

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