Validation of EUROArray HPV test using the VALGENT framework

Viti, Jessica; Poljak, Mario; Oštrbenk, Anja; Bhatia, Ramya; Boada, Elia Alcañiz; Cornall, Alyssa M.; Cuschieri, Kate; Garland, Suzanne M.; Xu, Lan; Arbyn, Marc

doi:10.1016/j.jcv.2018.09.005

Cited by 22 publications

(25 citation statements)

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“…The CLART® HPV4S (CLART4S) assay is a newly developed full-genotyping assay detecting 14 oncogenic (16,18,31,33,35,39,45,51,52,56,58,59,66,68) and two non-oncogenic HPV genotypes (6,11). It was evaluated using SurePath and ThinPrep screening samples collected from the Danish and Swedish cervical cancer screening programs, respectively.…”

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confidence: 99%

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Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

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“…CLART4S HPV, a sample was considered positive if at least one of the 14 genotypes(16,18,31,33,35,39,45, 51, 52, 56, 58, 59, 66, & 68) was detected. HPV6, and/or HPV11 present alone without any of the other 14 HPV genotypes were considered HPV screen negative.…”

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Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

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“…The CLART® HPV4S (CLART4S) microarray assay (GENOMICA SAU, Madrid, Spain) is intended as a primary HPV screening assay detecting individually 14 HPV genotypes (16,18,31,33,35,39,45,51,52, 56, 58, 59, 66 and 68). Additionally, the assay detects two non-oncogenic-HPV genotypes, HPV6 and 11.…”

Section: Introductionmentioning

confidence: 99%

Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

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Bhatia

et al. 2020

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Background To ensure the highest quality of human papillomavirus (HPV) testing in primary cervical cancer screening, novel HPV assays must be evaluated in accordance with the international guidelines. Furthermore, HPV assay with genotyping capabilities are becoming increasingly important in triage of HPV positive women in primary HPV screening. Here we evaluate a full genotyping HPV assay intended for primary screening.Methods The CLART® HPV4S (CLART4S) assay is a newly developed full-genotyping assay detecting 14 oncogenic (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and two non-oncogenic HPV genotypes (6, 11). It was evaluated using SurePath and ThinPrep screening samples collected from the Danish and Swedish cervical cancer screening programs, respectively. For calculation of sensitivity, 81 SurePath and 80 ThinPrep samples with confirmed ≥CIN2 were assessed. For clinical specificity analysis, 1,184 SurePath and 1,169 ThinPrep samples from women with <CIN2 histology were assessed. Sensitivity and specificity of the CLART4S assay was compared to an established reference test; the MGP-PCR (Modified General Primers GP5+/6+ with genotyping using Luminex). Inter and intra laboratory reproducibility of the assay was assessed using 540 SurePath and 520 ThinPrep samples, respectively. The genotype concordance between CLART4S and MGP-PCR was also assessed.Results In SurePath samples, the sensitivity of CLART4S was 0.90 (MGP-PCR =0.93) and the specificity was 0.91 (MGP-PCR=0.91); In ThinPrep samples the sensitivity of CLART4S was 0.98 (MGP-PCR=1.00) and specificity was 0.94 (MGP-PCR =0.87). The CLART4S was shown to be non-inferior to that of MGP-PCR for both sensitivity (p=0.002; p=0.01) and specificity (p=0.01; p=0.00) in SurePath and ThinPrep samples, respectively. Intra-laboratory reproducibility and inter-laboratory agreement was met for both media types. The individual genotype concordance between CLART4S and MGP-PCR was good agreement for almost all 14 HPV genotypes in both media types.Conclusions The CLART4S assay was proved non-inferior to the comparator assay MGP-PCR for both sensitivity and specificity using SurePath and ThinPrep cervical cancer screening samples from the Danish and Swedish screening programs, respectively. This is the first study to demonstrate clinical validation of a full-genotyping HPV assay conducted in parallel on both SurePath and ThinPrep collected samples.

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“…HPV assay development over the past decade has led to a host of PCR-based assays reporting high-risk HPV (hrHPV) findings with various degrees of data resolution. In this regard, HPV assays can be stratified into four categories: (i) consensus assays that report only positive or negative outcomes resulting from measurement of the presence of the 13 or 14 most common oncogenic HPV genotypes (genotypes 16,18,31,33,35,39,45,51,52,56,58,59, 68, and sometimes 66); (ii) consensus assays with limited genotype reporting, often for HPV16 and HPV18; (iii) HPV assays with extended genotyping, typically identifying HPV16 and -18 combined with more, but not all, of the oncogenic genotypes; and (iv) full genotyping assays with individual reporting of 14 oncogenic HPV genotypes. The Hybrid Capture 2 assay (HC2; Qiagen, Hilden, Germany) and GP5ϩ/6ϩ PCR-enzyme immunoassay (GP-EIA; DDL Diagnostic Laboratory, Rijswijk, The Netherlands) have been considered standard comparator assays, since both have demonstrated longitudinal evidence of protection against cervical precancer and cancer through randomized trials (5,6).…”

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“…To date, four VALGENT panels have been collected from the Belgian (VALGENT1) (9-11), Scottish (VALGENT2) (12)(13)(14)(15), Slovenian (VALGENT3) (16)(17)(18)(19)(20), and Danish (VAL-GENT4) (8) cervical cancer screening programs. VALGENT4 specifically comprises a panel of samples collected in SurePath medium; previously, the majority of clinically validated HPV assays for use in screening had been undertaken on samples collected with the ThinPrep system.…”

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Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

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The Validation of HPV Genotyping Tests (VALGENT) framework is an international cooperation designed to evaluate human papillomavirus (HPV) assays with genotyping capabilities. Here, we assessed the performance of the BD Onclarity assay using Danish SurePath cervical screening samples collected under the fourth VALGENT installment, consisting of 998 consecutive samples from a screening population and 297 enriched samples with abnormal cytology (100 with atypical squamous cells of undetermined significance [ASCUS], 100 with low-grade squamous intraepithelial lesions [LSIL], and 97 with high-grade squamous intraepithelial lesions [HSIL]). The Onclarity assay detects six HPV genotypes individually (genotypes 16, 18, 31, 45, 51, and 52) and eight genotypes in three bulks (genotypes 33 and 58; genotypes 56, 59, and 66; and genotypes 35, 39, and 68). The clinical performance of the Onclarity assay for the detection of cervical intraepithelial neoplasia of grade 2 or worse (≥CIN2) and of two consecutive cytology outcomes negative for intraepithelial lesion or malignancy (2×NILM) was assessed relative to that of the GP5+/6+ PCR-enzyme immunoassay (GP-EIA) by a noninferiority test. The relative sensitivity for ≥CIN2 was 1.00 (95% confidence interval [CI], 0.97 to 1.04), and the relative specificity for 2×NILM was 1.04 (95% CI, 1.02 to 1.06). The Onclarity assay was found to be noninferior to the GP-EIA in terms of both sensitivity (P = 0.0006) and specificity (P < 0.0001). The type-specific performance of the Onclarity assay was also assessed, using the GP5+/6+ PCR with Luminex genotyping (GP-LMNX) as the comparator. The Onclarity assay showed good concordance for almost all HPV genotype groups. A stability analysis of SurePath samples was also performed, where a SurePath aliquot was stored refrigerated for 7 months and the internal control of the Onclarity assay was used as a marker for cellularity. The threshold cycle (CT) value was the same (24.8) in the first and second Onclarity runs, showing that a SurePath sample can be stored refrigerated for 7 months and still remain a valid test specimen.

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Validation of EUROArray HPV test using the VALGENT framework

Abstract: At the predefined cut-off, EUROArray HPV was less sensitive than HC2 for the detection of CIN2+. However, when an optimised cut-off was applied, EUROArray HPV fulfilled international criteria for its use in cervical cancer screening.

Cited by 22 publications

References 28 publications

Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

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