Clinical validation of the Liferiver Harmonia HPV assay using the VALGENT-4 framework

Ramya Bhatia, Kate Cuschieri, Ditte Møller Ejegod, J.H. Bonde, Marc Arbyn

Research output: Contribution to conferenceAbstractpeer-review

Abstract / Description of output

Background / Objectives To evaluate the clinical performance of the Liferiver Harmonia HPV assay (Harmonia) using the international Validation of HPV Genotyping Tests (VALGENT-4) framework. Results The VALGENT-4 panel consisted 1,297 samples from women aged 30-59 years who participated in the Danish cervical cancer screening program (998 consecutive samples from routine screening enriched with 299 cytological abnormal samples (100 ASCUS, 100 HSIL and 99 HSIL). Harmonia identifies separately HPV16 and HPV18 and 12 other hrHPV types in aggregate. Disease was definedas histologically confirmed CIN2+ (n= 119 [denominator for sensitivity]), whereas two consecutive negative cytology results were accepted as proxy for non-disease (n=898 [denominator for specificity]). Performance relative to GP5+/6+-PCR-LMNX (standard comparator test) was assessed by a non-inferiority test. Intra/inter-laboratory reproducibility of Harmonia was performed in a subset of 500 randomly selected samples. The benchmarks for acceptable HPV DNA tests in cervical cancer screening are: 0.90, 0.98 and 0.87 for relative sensitivity, relative specificity and inter/intra-reproducibility, respectively. Conclusion The relative sensitivity and specificity of Harmonia vs GP5+/6+-PCR-LMNX was 1.06 (95% CI, 1.02-1.11; pn.inf < 0.001) and 0.97 (95% CI, 0.85-0.90; pn.inf = 1.000), respectively. Application of an optimised a-posteriori cut-off for HPV16, HPV18 and other hrHPV types in aggregate led to the relative values of 1.04 (95% CI, 0.99-1.08; 192/490pn.inf < 0.001) and 1.01 (95% CI, 0.99-1.03; pn.inf = 0.002), respectively. The assay showed good intra/inter-laboratory reproducibility (reproducibility ≥ 95%).
Original languageEnglish
DOIs
Publication statusPublished - Dec 2018
EventEUROGIN 2018 - From control to elimination of HPV induced cancers - Lisbon, Portugal
Duration: 2 Dec 20185 Dec 2018
https://www.eurogin.com/2018/

Conference

ConferenceEUROGIN 2018 - From control to elimination of HPV induced cancers
Abbreviated titleEurogin 2018
Country/TerritoryPortugal
CityLisbon
Period2/12/185/12/18
Internet address

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