Performance of the digene LQ, RH and PS HPVs genotyping systems on clinical samples and comparison with HC2 and PCR-based Linear Array

Godínez, J.M.; Tous, Sara; Baixeras, Núria; Moreno-Crespi, Judith; Alejo, María; Lejeune, Marylène; Bravo, Ignacio G.; Bosch, F. Xavier; Sanjosé, Sílvia de

doi:10.1186/1750-9378-6-23

Cited by 9 publications

(15 citation statements)

References 35 publications

(40 reference statements)

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“…The RH test kit utilizes the HR-HPVGP5+/6+ consensus primer which targets the L1 region of the HPV genome. Using this technique, it has demonstrated high concordance with the previously established HR-hybrid HC2 system [13]. Therefore, this RH test offers the opportunity to detect HR-HPV genotypes in HNSCC and may identify similarities or differences in the HPV genotypes in both cervical cancer and HNSCC, given that HPV is sexually transmitted.…”

Section: Discussionmentioning

confidence: 85%

High-risk HPV genotypes and P16INK4a expression in a cohort of head and neck squamous cell carcinoma patients in Singapore

et al. 2016

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Human papillomavirus (HPV), especially HPV16 genotype, is associated with oropharyngeal squamous cell carcinoma (OPSCC). We aim to determine the prevalence and characterize the high-risk (HR)-HPV genotypes in head and neck SCC (HNSCC) in a South-East Asian multi-ethnic society in Singapore and examine its prognostic significance.159 HNSCC archival tissue samples were retrieved and tumour DNA was screened for 18 HR-HPV genotypes using a PCR-based assay (Qiagen, digene HPV genotyping RH test). P16 protein overexpression was identified using immunohistochemistry (IHC). Statistical correlation between clinical outcomes were performed between HPV-positive and negative HNSCC patients.Six HR-HPVs (HPV16, 18, 31, 45, 56, 68) were detected in 90.6% of HNSCC; and 79.9% had multiple HPV genotypes detected. HPV31 and HPV45 were the most prevalent (79.2% and 87.4%, respectively); and HPV16 was predominantly found in OPSCC (p < 0.001). HPV-DNA PCR assay yielded a high sensitivity (96%) but low specificity (11%) when compared to p16 immunohistochemistry as the reference standard.P16-positive HNSCC was predominantly observed in OPSCC (73.7%; p = 0.005); and p16-positive OPSCC exhibited improved overall survival compared to p16-negative OPSCC (p = 0.022). Similarly, smoking and alcohol consumption were poor prognostic factors of overall survival (p = 0.007; p = 0.01) in OPSCC patients.HR-HPVs were identified in 90.6% of HNSCC patients using the HPV-DNA PCR assay. This test had a poor specificity when compared to p16 IHC; making it an unreliable detection technique in selecting patients for radiation dose de-escalation treatment protocol. P16-positive tumor was predominantly found in the oropharynx these patients demonstrated better overall survival than those with p16-negative OPSCC.

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Section: Discussionmentioning

confidence: 85%

High-risk HPV genotypes and P16INK4a expression in a cohort of head and neck squamous cell carcinoma patients in Singapore

et al. 2016

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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)(6)(7)(8)(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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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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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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“…Godinez et al [22] recently performed clinical validation of QIAGEN LQ in women > 40 years old. However, no clinical validation has been performed in women aged > 18 years old.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2013

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A new genotyping-based DNA assay (Digene LQ®) was developed recently. The primary aim was to assess the distribution of HPV types using this new assay in atypical squamous cells of undeterminate significance (ASCUS). The secondary aim was to correlate the HPV types with the severity of the disease. The study population comprised 376 ASCUS women. The women were all Hybrid Capture II (HCII) positive and were admitted in three European referral gynecology clinics between 2007 and 2010. A colposcopy with histological examination was performed in all these patients. HPV 16 was typed in 40 % of patients, HPV 18 in 7 %, and HPV 31 in 17 %, and 18 % of patients had mixed genotypes. Patients aged over 30 more often had the HPV 16 genotype than patients aged under 30 (29 % vs. 11 %, chi-square test p < 0.001). The risk of cervical intra-epithelial neoplasia of grade 2 or more (CIN2 +) when HPV 18 positive is lower than the probability associated with HPV 16 or HPV 31: 28 % vs. 58 % and 52 %, respectively (chi-square test, p = 0.005 and p = 0.05, respectively). The Digene LQ®, a new sequence-specific hybrid capture sample preparation, is fast and efficient and allows high-throughput genotyping of 18 HR HPV types by PCR compared to traditional non-sequence-specific sample preparation methods.

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Performance of the digene LQ, RH and PS HPVs genotyping systems on clinical samples and comparison with HC2 and PCR-based Linear Array

Cited by 9 publications

References 35 publications

High-risk HPV genotypes and P16INK4a expression in a cohort of head and neck squamous cell carcinoma patients in Singapore

High-risk HPV genotypes and P16INK4a expression in a cohort of head and neck squamous cell carcinoma patients in Singapore

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

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

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