VALGENT: A protocol for clinical validation of human papillomavirus assays

Arbyn, Marc; Depuydt, Christophe; Benoy, Ina; Bogers, Johannes; Cuschieri, Kate; Schmitt, Markus; Pawlita, Michael; Geraets, D.T.; Heard, Isabelle; Gheit, Tarik; Tommasino, Massimo; Poljak, Mario; Bonde, Jesper; Quint, Wim

doi:10.1016/j.jcv.2015.09.014

Cited by 129 publications

(133 citation statements)

References 39 publications

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“…GP5ϩ/6ϩ primers have long been known to be deficient in detection of HPV53 (18,19), and a series of meta-analyses of global HPV type distribution (20)(21)(22) has always considered HPV53 to be undetectable by GP5ϩ/6ϩ PCR. Underdetection of HPV68 has been reported for GP5ϩ/6ϩ PCR in two independent comparisons against another HPV genotyping method, Papillocheck (23,24), and for a modified GP5ϩ/6ϩ PCR assay (25), which was thought to be related to a deficiency in detecting one of two HPV68 subtypes (23).…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, GP5ϩ/6ϩ-based PCR assays for 14 high-risk types have been widely validated against clinical outcomes in large population-based screening programs and show improved clinical performance in comparison to cytology (4,5) and similar (23,24) or better (26) clinical performance than other HPV tests. E7-MPG, on the other hand, has not been clinically evaluated and, indeed, was not originally designed for population-level screening.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Two Widely Used Human Papillomavirus Detection and Genotyping Methods, GP5+/6+-Based PCR Followed by Reverse Line Blot Hybridization and Multiplex Type-Specific E7-Based PCR

et al. 2016

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f GP5؉/6؉-based PCR followed by reverse line blot hybridization (GP5؉/6؉RLB) and multiplex type-specific PCR (E7-MPG) are two human papillomavirus (HPV) genotyping methodologies widely applied in epidemiological research. We investigated their relative analytical performance in 4,662 samples derived from five studies in Bhutan, Rwanda, and Mongolia coordinated by the International Agency for Research on Cancer (IARC). A total of 630 samples were positive by E7-MPG only (13.5%), 24 were positive by GP5؉/6؉RLB only (0.5%), and 1,014 were positive (21.8%) by both methods. Ratios of HPV type-specific positivity of the two tests (E7-MPG:GP5؉/6؉RLB ratio) were calculated among 1,668 samples that were HPV positive by one or both tests. E7-MPG:GP5؉/6؉RLB ratios were >1 for all types and highly reproducible across populations and sample types. E7-MPG:GP5؉/6؉RLB ratios were highest for HPV53 (7.5) and HPV68 (7.1). HPV16 (1.6) and HPV18 (1.7) had lower than average E7-MPG:GP5؉/6؉RLB ratios. Among E7-MPG positive infections, median mean fluorescence intensity (MFI; a semiquantitative measure of viral load) tended to be higher among samples positive for the same virus type by GP5؉/6؉RLB than for those negative for the same type by GP5؉/6؉RLB. Exceptions, however, included HPV53, -59, and -82, for which the chances of being undetected by GP5؉/6؉RLB appeared to be MFI independent. Furthermore, the probability of detecting an additional type by E7-MPG was higher when another type was already detected by GP5؉/6؉RLB, suggesting the existence of masking effects due to competition for GP5؉/6؉ PCR primers. In conclusion, this analysis is not an evaluation of clinical performance but may inform choices for HPV genotyping methods in epidemiological studies, when the relative merits and dangers of sensitivity versus specificity for individual types should be considered, as well as the potential to unmask nonvaccine types following HPV vaccination. Human papillomavirus (HPV) DNA detection and genotyping are central to molecular epidemiological studies of HPV natural history and carcinogenicity, as well as to evaluations of HPV vaccine efficacy and effectiveness. There are various PCR-based methods for HPV DNA detection and genotyping, of which one of the most commonly used in epidemiological studies is the GP5ϩ/6ϩ primer set targeting conserved sequences within the L1 gene, thus allowing detection of a broad range of mucosal HPV types in a single reaction. The HPV genotype can subsequently be identified by various methods, of which the most commonly used is hybridization with type-specific probes using a reverse line blot hybridization assay (henceforth referred to as GP5ϩ/6ϩRLB) (1). The GP5/6 primers were initially developed to maximize detection of HPV6, and were subsequently elongated at their 3= ends to generate the primers GP5ϩ and GP6ϩ to improve the detection of a broader range of HPV types (3). This methodology has been widely validated against clinical outcomes in large population-based screening programs and shows favorable c...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Comparison of Two Widely Used Human Papillomavirus Detection and Genotyping Methods, GP5+/6+-Based PCR Followed by Reverse Line Blot Hybridization and Multiplex Type-Specific E7-Based PCR

et al. 2016

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“…Larger studies in representative populations are warranted to confirm our observation that the Anyplex and the Euroarray have similar analytical performance for detecting HPV in cervical samples. Both assays will be assessed through VALGENT for clinical accuracy for cervical precancer in order to validate the performance in the context of primary cervical cancer screening (Arbyn et al, 2015a). Further work is also required to evaluate relative assay performance for archival formaldehyde fixed paraffin embedded tumour samples (Lillsunde Larsson et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Analytical performance evaluation of Anyplex II HPV28 and Euroarray HPV for genotyping of cervical samples

Latsuzbaia

Tapp

Nguyen

et al. 2016

Diagnostic Microbiology and Infectious Disease

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“…This diagnostic value of a cytological HSIL result (conventional or LBC) in the diagnosis of CIN2+ lesions is good, but a combination of tests, for example serial co-testing, could raise this value [36]. It can be concluded from this systematic review that adopting a policy of eradication of precancerous or cancerous lesions solely based on cytology will not reach its target.…”

Section: Discussion/conclusionmentioning

confidence: 99%

The Positive Predictive Value of High-Grade Squamous Intraepithelial Lesion on Cytology for the Histological Diagnosis of Cervical Intraepithelial Neoplasia 2 or Higher: A Systematic Review

et al. 2019

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Cervical cancer is a major worldwide health problem. Therefore, regular cervical screening in order to make an early diagnosis can help to prevent cervical cancer, through identifying and treating preinvasive cervical lesions. The aim of this review is to evaluate the correlation between the cytological screening result and the final gold standard histological outcome in the diagnosis of cervical lesions. More specifically, the correlation between high-grade intraepithelial lesion (HSIL) on cytology and histological cervical intraepithelial neoplasia grade 2 or higher (CIN2+) was intended, by calculating the positive predictive value (PPV). PPV is an important value from a clinical point of view. An electronic search was carried out in the electronic databases MEDLINE (through PubMed) and the Cochrane Library (last searched beginning of December 2017), supplemented with the related article feature in PubMed and snowballing. Article selection (predefined inclusion and exclusion criteria) and data extraction were evaluated by two independent reviewers (N.K. and A.V.L.). After identifying 1,146 articles, 27 articles were finally included in this systematic review, representing 28,783 cytological HSIL diagnoses in total. The PPV of HSIL was 77.5% (range: 45.4–95.2%) for the histological diagnosis of CIN2+ and 55.4% (range: 36.4–67.6%) for the diagnosis of CIN3+. In this systematic review, 77.5% of the HSIL-positive women eventually had a CIN2+ diagnosis. The diagnostic value of a cytological HSIL result (conventional or liquid-based cytology) in the diagnosis of CIN2+ lesions is good, but a combination of tests could raise this value.

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VALGENT: A protocol for clinical validation of human papillomavirus assays

Cited by 129 publications

References 39 publications

Comparison of Two Widely Used Human Papillomavirus Detection and Genotyping Methods, GP5+/6+-Based PCR Followed by Reverse Line Blot Hybridization and Multiplex Type-Specific E7-Based PCR

Comparison of Two Widely Used Human Papillomavirus Detection and Genotyping Methods, GP5+/6+-Based PCR Followed by Reverse Line Blot Hybridization and Multiplex Type-Specific E7-Based PCR

Analytical performance evaluation of Anyplex II HPV28 and Euroarray HPV for genotyping of cervical samples

The Positive Predictive Value of High-Grade Squamous Intraepithelial Lesion on Cytology for the Histological Diagnosis of Cervical Intraepithelial Neoplasia 2 or Higher: A Systematic Review

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