Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection

Halfon, Philippe; Benmoura, D.; Agostini, Aubert; Khiri, Hacène; Pénaranda, Guillaume; Martineau, Agnès; Blanc, B.

doi:10.1016/j.jcv.2010.05.008

Cited by 20 publications

(22 citation statements)

References 23 publications

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“…Overall, high agreement (96.5%) for HR HPV detection was observed between the two assays, as observed in previous studies (9,15). The agreement on misclassified cases indicates that HPV DNA-negative ՆCIN2 are not due simply to a technical malfunctioning of the test that randomly reduces analytical sensitivity but probably share characteristics reducing the probability of detecting DNA by any means.…”

Section: Discussionsupporting

confidence: 89%

Comparison of Clinical Performance of Abbott RealTi m e High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

et al. 2011

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The noninferiority score test revealed that the clinical sensitivity and specificity of the Abbott RealTime HR HPV test were not inferior (P ‫؍‬ 0.004 and 0.009, respectively) to those of HR HC2. Overall agreement between the two assays was 96.5%, with a k value of 0.86 (CI 95%, 0.82 to 0.91). We evaluated the intralaboratory reproducibility by retesting 521 samples at least 4 weeks after the first test; the crude agreement between the first and second test was 98.5%, with an overall k value of 0.97 (CI 95%, 0.95 to 0.99). This test fully satisfies the requirements of a primary cervical cancer screening test. This assay differentiates between HPV16, HPV18, and non-HPV16/18 types in every specimen, but how to use this information in a screening setting still is unclear.The etiologic link between persistent high-risk human papillomavirus (HR HPV) infections and cervical cancer and its immediate precancerous lesions has been widely demonstrated. A recent IARC classification reports solid evidence for a causal link to cervical cancer for only 12 HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59), which are defined as high-risk HPV (2).Large randomized trials produced sound evidence about the efficacy of screening with an HPV DNA test in reducing cervical cancer incidence (19) and mortality (20). According to trial results, an HPV test used as a cervical cancer screening test has three advantages: a higher long-term negative predictive value (NPV) that permits extending the screening interval without increasing the interval risk of cancer, a clinical sensitivity of 90 to 95% for cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) (1,3,6,7,13,17,18), and a marked reduction of CIN2/3 and cancer among test-negative women in the subsequent screening round (19).Several studies (12, 21) suggest that infections supported by HPV16 and HPV18 are associated with a higher risk for the progression of cervical cancer. Consequently, the genotyping of HPV16 and HPV18 has been proposed to guide the management of HPV-positive women throughout the follow-up procedures (12). Usually, viral tests are used to understand the etiology of symptomatic diseases. However, the HR HPV test in screening is aimed at preventing cervical cancer in an asymptomatic population, therefore it is useful only when it is able to detect clinically relevant infections. In other words, HPV testing for screening purposes needs optimal balance between clinical sensitivity and specificity. At present, the HPV assays considered clinically validated for screening purposes are the hybrid capture 2 HPV test (HC2) and the GP5ϩ/6ϩ-PCR enzyme immunoassay (EIA) (24). New candidate assays should prove their value in large prospective screening studies or should prove to be noninferior to a validated reference assay in clinical equivalence studies on specimens from a cervical screening cohort. An international consortium recently published guidelines (14) defining the appropriate study design and sample size to measure the sensitivity, specificity, and re...

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Section: Discussionsupporting

confidence: 89%

Comparison of Clinical Performance of Abbott RealTi m e High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

et al. 2011

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“…In previous evaluations, RealTime demonstrated analytical specificity superior to that of hc2 and analytical sensitivity similar to that of hc2 (23,39). The clinical sensitivity of RealTime for CIN2ϩ lesions in six published studies performed with different study populations was at least comparable to that of hc2 (14,20,22,25,39,47). The clinical specificity and PPVs of RealTime and hc2 for either CIN2ϩ or CIN3ϩ in a triage of women with abnormal cervical cytology smears were comparable in one study (22), while RealTime performed slightly better in another study (14).…”

mentioning

confidence: 78%

“…The RealTime assay was performed with the fully automated nucleic acid preparation instrument m2000sp and the real-time PCR instrument m2000rt (Abbott) by following the manufacturer's instructions as previously described (20,23). The assay uses four channels for the detection of fluorescent signals, one for the detection of an internal process control (136-bp region of human ␤-globin) for sample adequacy and DNA extraction and amplification, a second one for the detection of HPV16, a third for the detection of HPV18, and a fourth for the aggregate detection of the 12 HPV types, i.e., HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV66, and HPV68 (23).…”

Section: Methodsmentioning

confidence: 99%

Comparison of Clinical and Analytical Performance of the Abbott RealTime High Risk HPV Test to the Performance of Hybrid Capture 2 in Population-Based Cervical Cancer Screening

et al. 2011

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The clinical performance of the Abbott RealTime High Risk HPV (human papillomavirus) test (RealTime) and that of the Hybrid Capture 2 HPV DNA test (hc2) were prospectively compared in the population-based cervical cancer screening setting. In women >30 years old (n ‫؍‬ 3,129), the clinical sensitivity of RealTime for detection of cervical intraepithelial neoplasia of grade 2 (CIN2) or worse (38 cases) and its clinical specificity for lesions of less than CIN2 (3,091 controls) were 100% and 93.3%, respectively, and those of hc2 were 97.4% and 91.8%, respectively. A noninferiority score test showed that the clinical specificity (P < 0.0001) and clinical sensitivity (P ‫؍‬ 0.011) of RealTime were noninferior to those of hc2 at the recommended thresholds of 98% and 90%. In the total study population (women 20 to 64 years old; n ‫؍‬ 4,432; 57 cases, 4,375 controls), the clinical sensitivity and specificity of RealTime were 98.2% and 89.5%, and those of hc2 were 94.7% and 87.7%, respectively. The analytical sensitivity and analytical specificity of RealTime in detecting targeted HPV types evaluated with the largest sample collection to date (4,479 samples) were 94.8% and 99.8%, and those of hc2 were 93.4% and 97.8%, respectively. Excellent analytical agreement between the two assays was obtained (kappa value, 0.84), while the analytical accuracy of RealTime was significantly higher than that of hc2. RealTime demonstrated high intralaboratory reproducibility and interlaboratory agreement with 500 samples retested 61 to 226 days after initial testing in two different laboratories. RealTime can be considered to be a reliable and robust HPV assay clinically comparable to hc2 for the detection of CIN2؉ lesions in a populationbased cervical cancer screening setting.High-risk genotypes of human alpha papillomaviruses (hrHPV) are etiologically linked to virtually all cervical carcinomas and their immediate precursors-high-grade cervical intraepithelial neoplasia (CIN) lesions (49). HPV DNA testing has therefore become an important part of cervical carcinoma screening and management algorithms in several countries (reviewed in references 10 and 41). The four main clinical applications of HPV DNA testing at present are (i) triage of women with equivocal screening cytology results in order to determine which patients should be referred for colposcopy, (ii) follow-up of women with abnormal screening cytology results who are negative at initial colposcopy/biopsy, (iii) prediction of the therapeutic outcome after treatment of high-grade CIN lesion, and (iv) primary screening of women Ն30 years old in combination with the Pap smear to detect cervical cancer precursors (1, 3, 10-11, 13, 15).Several in-house and more than 35 commercial assays for the detection of hrHPV are currently available (reviewed in references 11, 40, and 44). These assays have significantly different clinical performance for high-grade CIN lesion detection and are not necessarily useful for primary screening (21, 40). The Hybrid Capture 2 HPV DNA Test (hc2; Qia...

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“…The results showed that the two assays produced comparable results but some analytical and clinical discrepancies were noted [71]. In the fifth study, performed on 143 samples collected from French women referred for colposcopy, the agreement between RealTime and hc2 was 93% (k value 0.85) [73]. Finally, in a study that compared the clinical sensitivity and specificity of seven HPV assays for the detection of high-grade CIN in a population of 858 women referred for colposcopy because of abnormal cytology, RealTime had a sensitivity of 98.9%, specificity of 31.5% and PPV of 27.8% for the detection of CIN2+ lesions [72].…”

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

confidence: 96%

“…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%

Commercially available assays for multiplex detection of alpha human papillomaviruses

Poljak

Kocjan

2010

Expert Review of Anti-infective Therapy

115

129

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Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection

Cited by 20 publications

References 23 publications

Comparison of Clinical Performance of Abbott RealTi m e High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

Comparison of Clinical Performance of Abbott RealTi m e High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

Comparison of Clinical and Analytical Performance of the Abbott RealTime High Risk HPV Test to the Performance of Hybrid Capture 2 in Population-Based Cervical Cancer Screening

Commercially available assays for multiplex detection of alpha human papillomaviruses

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