HPV genotype distribution according to severity of cervical neoplasia using the digene HPV genotyping LQ test

Halfon, Philippe; Lindemann, María Luisa Mateos; Raimondo, Audrey; Ravet, Sophie; Camus, Claire; Khiri, Hacène; Pénaranda, Guillaume; Sideri, Mario; Sandri, Maria Teresa

doi:10.1007/s00705-012-1584-4

Cited by 10 publications

(10 citation statements)

References 29 publications

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“…A second aliquot of GP5ϩ/6ϩ amplification product (4 l) was genotyped by the use of the commercially available LMNX Genotyping kit HPV GP HR (LMNX) (Diassay; previous version marketed as the digene HPV Genotyping LQ Test by Qiagen, Hilden, Germany) according to the manufacturer's instructions (20,(23)(24)(25)(26)(27).…”

Section: Methodsmentioning

confidence: 99%

“…Concurrent genotyping for HPV16 and HPV18 could be beneficial for the triage of hrHPV-positive women (15), as these HPV types have a higher risk of causing cervical cancer than the other hrHPVs (16-19). The value of genotyping of hrHPVs other than HPV16 and HPV18 (20, 21) is currently unknown, although genotyping can resolve type-specific persistence issues more accurately than repeated measurements with a consensus test, which may assist in risk stratification for women in screening populations and diagnostic settings (22).The LMNX Genotyping Kit GP HR (LMNX; Diassay BV, Rijswijk, the Netherlands; previous version marketed as the digene HPV Genotyping LQ Test by Qiagen, Hilden, Germany) (20,(23)(24)(25)(26)(27), based on the clinically validated GP5ϩ/6ϩ PCR assay (5-9), offers an alternative readout method for the EIA. LMNX provides high-throughput and full genotyping of the 14 high-risk (hr)HPV types described earlier and has recently been modified to incorporate an internal control for a human DNA target to minimize the chance of technical false-negative test results.…”

mentioning

confidence: 99%

“…The LMNX Genotyping Kit GP HR (LMNX; Diassay BV, Rijswijk, the Netherlands; previous version marketed as the digene HPV Genotyping LQ Test by Qiagen, Hilden, Germany) (20,(23)(24)(25)(26)(27), based on the clinically validated GP5ϩ/6ϩ PCR assay (5-9), offers an alternative readout method for the EIA. LMNX provides high-throughput and full genotyping of the 14 high-risk (hr)HPV types described earlier and has recently been modified to incorporate an internal control for a human DNA target to minimize the chance of technical false-negative test results.…”

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Clinical Evaluation of a GP5+/6+-Based Luminex Assay Having Full High-Risk Human Papillomavirus Genotyping Capability and an Internal Control

et al. 2014

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The LMNX genotyping kit HPV GP (LMNX) is based on the clinically validated GP5؉/6؉ PCR, with a genotyping readout as an alternative for the more established enzyme immunoassay (EIA) detection of 14 targeted high-risk human papillomavirus (HPV) types. LMNX is additionally provided with an internal control probe. Here, we present an analysis of the clinical performance of the LMNX using a sample panel and infrastructure provided by the international VALGENT (Validation of Genotyping Tests) project. This panel consisted of cervical specimens from approximately 1,000 women attending routine screening, "enriched" with 300 women with abnormal cytology. Cases were defined as women classified with cervical intraepithelial neoplasia (CIN) grade 2؉ (CIN2؉) (n ‫؍‬ 102) or CIN3؉ (n ‫؍‬ 55) within the previous 18 months. Controls were women who had normal cytology results over two subsequent screening rounds at a 3-year interval (n ‫؍‬ 746). The GP5؉/6؉-PCR EIA (EIA) was used as a comparator assay and showed sensitivities of 94.1% and 98.2% for CIN2؉ and CIN3؉, respectively, with a clinical specificity of 92.4% among women aged >30 years. The LMNX demonstrated clinical sensitivities of 96.1% for CIN2؉ and of 98.2% for CIN3؉ and a clinical specificity of 92.6% for women aged >30 years. The LMNX and EIA were in high agreement (Cohen's kappa ‫؍‬ 0.969) for the detection of 14 hrHPVs in aggregate, and no significant difference was observed (McNemar's P ‫؍‬ 0.629). The LMNX internal control detected 0.6% inadequate specimens. Based on our study results, we consider the LMNX, similarly to the EIA, useful for HPV-based cervical cancer screening.H uman papillomavirus (HPV) tests that have been validated for use in a clinical setting usually target 13 or 14 genotypes. These HPVs have been classified by the International Agency for Research on Cancer (IARC) as carcinogenic, i.e., HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, and HPV59 (class 1), probably carcinogenic, i.e., HPV68 (class 2A), or possibly carcinogenic, i.e., HPV66 (class 2B) (1). The Hybrid Capture 2 (HC2; Qiagen, Hilden, Germany) assay (2-4) and GP5ϩ/6ϩ PCR-based enzyme immunoassay (EIA) kit HPV GP HR (EIA; Diassay, Rijswijk, the Netherlands) (5-9) were the first HPV tests to be clinically validated for primary screening on the basis of longitudinal results from large screening studies (10). Testing for high-risk HPV (hrHPV) nucleic acids is also useful for triage of women with equivocal or mildly abnormal cytology for colposcopy and as a test of cure of treatment (10).Several novel HPV tests have been fully or partially validated by showing noninferiority to HC2 or EIA and high reproducibility (11), as has been extensively reviewed by Arbyn et al. (10) and reported in additional studies (12)(13)(14). These tests usually detect around 14 hrHPVs in aggregate, but some provide concurrent (partial) genotype-specific information. Concurrent genotyping for HPV16 and HPV18 could be beneficial for the triage of hrHPV-positive women (15), as the...

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Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

mentioning

confidence: 99%

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Clinical Evaluation of a GP5+/6+-Based Luminex Assay Having Full High-Risk Human Papillomavirus Genotyping Capability and an Internal Control

et al. 2014

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“…Hybrid Capture® 2 (HC2) allows the detection of at least one of the 13 types of HPV-HR (16,18,31,33,35,39,45,51,52, 56, 58, 59 and 68) and / or at least one of the 5 types of HPV-BR (6,11,42,43,44). It can detect about 1 µg of HPV genome per ml, or about 5000 copies / ml.…”

Section: Capture Hybridization: Hybrid Capture® 2 (Digen Hpv Hc2 Dna mentioning

confidence: 99%

Evaluation of the Performance of PCR and Hybrid Capture 2 in the Detection of Human Papillomavirus Associated with Cervical Cancer in Algeria

Mohamed¹

2018

CRJ

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To evaluate and compare the performance of PCR (polymerase chain reaction) and second-generation capture hybridization (HC2) in the detection of high-risk Human Papillomavirus (HPV-HR) and to estimate their prevalence among normal cervical, dysplastic and cervical cancer in the Algerian population. 264 women were subjected to cyto-histological and colposcopic diagnostics and to the HPV test by PCR and Hybrid capture 2. The search for HPV DNA by conventional PCR was carried out with MY09 / 11 consensus primers and the typing of HPV with the hybridization technique in solution, Digene Sharp Signal for PCR. Hybrid Capture® 2 was performed with the digene HPV HC2 DNA Test kit. The PCR and HC2 performance tests included sensitivity, specificity, positive and negative predictive values, Youden's index, and Yule's Q coefficient. HPV-HR research has shown that these viruses are associated with 100% high-grade lesions, 88.2% by PCR and 83.3% by HC2 (p = 0.8) with invasive cancer. The PCR and HC2 performance tests were in favor of HCV HPV testing which was more sensitive, more specific, more predictive and more effective. The results on the prevalence of HPV-HR associated with cervical lesions are comparable to those in the literature. In comparison with PCR, the capture hybridization technique 2 is recommended for HPV diagnosis because of its better performance and simplicity.

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Prevalence, genotypes and phylogenetic analysis of human papillomaviruses (HPV) in northeast Iran

Sabet

Mosavat

Ghezeldasht

et al. 2021

International Journal of Infectious Diseases

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Objectives: Human papillomaviruses (HPV) are the main etiology of invasive cervical cancer. Together HPV and viral hepatitis account for the cause of 25% of cancers in developing countries. To evaluate the association between population movements and the spread of HPV, this study looked at prevalence, genotypes, and phylogenetic assessment of HPV in Great Khorasan, a pilgrimage-tourism province in northeast Iran. Methods: From March 2013 to July 2018, 567 samples were collected from three groups in Khorasan: Razavi and North Khorasan provinces (highly mobile population); South Khorasan province (conservative and desert); and diverse group (tourists). Results: HPV prevalence was 48.4% in Razavi and North Khorasan (first group); 19.9% in South Khorasan (second group); and 33.6% in the diverse group. The four most common HPV genotypes were HPV-6, 11, 51 and 16, in the first group; HPV-6, 11, 16 and 58 in the second group; and HPV-6, 11, 16 and 53/89 in the diverse group. The most frequent genotypes that are known as high risk for cervical cancer were HPV-51 in the first group, HPV-16 in the second group and the diverse group. Among low-risk genotypes, HPV-6, and HPV-11 were more frequent in all groups. DNA sequencing and phylogenetic analysis of 20 HPVpositive samples showed that the distributions of the HPV genotypes were HPV-6 (50%), 11 (10%), 67 (5%), 16 (15%), 31 (10%), 54 (5%), and 89 (5%). Conclusions: The findings show that areas associated with population movement should be frequently monitored for infectious diseases, while conservative and less populated areas have less risk for virus spread and endemicity. Health authorities should focus more on the establishment of HPV diagnostic facilities, screening, vaccination, and enhancement of public knowledge in these regions.

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HPV genotype distribution according to severity of cervical neoplasia using the digene HPV genotyping LQ test

Cited by 10 publications

References 29 publications

Clinical Evaluation of a GP5+/6+-Based Luminex Assay Having Full High-Risk Human Papillomavirus Genotyping Capability and an Internal Control

Clinical Evaluation of a GP5+/6+-Based Luminex Assay Having Full High-Risk Human Papillomavirus Genotyping Capability and an Internal Control

Evaluation of the Performance of PCR and Hybrid Capture 2 in the Detection of Human Papillomavirus Associated with Cervical Cancer in Algeria

Prevalence, genotypes and phylogenetic analysis of human papillomaviruses (HPV) in northeast Iran

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