Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening

dc.contributor.authorGustavsson, Inger
dc.contributor.authorAarnio, Riina
dc.contributor.authorMyrnäs, Mattias
dc.contributor.authorHedlund-Lindberg, Julia
dc.contributor.authorTaku, Ongeziwe
dc.contributor.authorMeiring, Tracy
dc.contributor.authorWikström, Ingrid
dc.contributor.authorEnroth, Stefan
dc.contributor.authorWilliamson, Anna-Lise
dc.contributor.authorOlovsson, Matts
dc.contributor.authorGyllensten, Ulf
dc.date.accessioned2019-12-10T09:22:32Z
dc.date.available2019-12-10T09:22:32Z
dc.date.issued2019-08-22
dc.date.updated2019-08-25T03:22:49Z
dc.description.abstractAbstract Background The indicating FTA card is a dry medium used for collection of cervical samples. HPVIR is a multiplex real-time PCR test that detects 12 high-risk human papillomavirus types (hrHPV) and provides single genotype information for HPV16, − 31, − 35, − 39, − 51, − 56, and − 59 and pooled type information for HPV18/45 and HPV33/52/58. The aim of this study was to evaluate whether a strategy with cervical samples collected on the FTA card and subsequently analysed with the HPVIR test complies with the criteria of the international guidelines for a clinically validated method for cervical screening. Methods We performed a non-inferiority test comparing the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a clinically validated reference test (Cobas® HPV test) based on liquid-based cytology (LBC) samples. Two clinical samples (LBC and FTA) were collected from 896 participants in population-based screening. For evaluation of the specificity we used 799 women without ≥ CIN2, and for clinical sensitivity we used 67 women with histologically confirmed ≥ CIN2. The reproducibility was studied by performing inter- and intra-laboratory tests of 558 additional clinical samples. Results The clinical sensitivity and specificity for samples collected on the FTA card and analysed using the HPVIR test were non-inferior to samples analysed with the Cobas® HPV test based on LBC samples (non-inferiority test score, p = 1.0 × 10− 2 and p = 1.89 × 10− 9, respectively). Adequate agreement of > 87% was seen in both the intra- and inter-laboratory comparisons. Conclusions Samples collected on the indicating FTA card and analysed with HPVIR test fulfil the requirements of the international guidelines and can therefore be used in primary cervical cancer screening.
dc.identifier.apacitationGustavsson, I., Aarnio, R., Myrnäs, M., Hedlund-Lindberg, J., Taku, O., Meiring, T., ... Gyllensten, U. (2019). Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening. http://hdl.handle.net/11427/30701en_ZA
dc.identifier.chicagocitationGustavsson, Inger, Riina Aarnio, Mattias Myrnäs, Julia Hedlund-Lindberg, Ongeziwe Taku, Tracy Meiring, Ingrid Wikström, et al "Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening." (2019) http://hdl.handle.net/11427/30701en_ZA
dc.identifier.citationVirology Journal. 2019 Aug 22;16(1):107
dc.identifier.ris TY - Journal Article AU - Gustavsson, Inger AU - Aarnio, Riina AU - Myrnäs, Mattias AU - Hedlund-Lindberg, Julia AU - Taku, Ongeziwe AU - Meiring, Tracy AU - Wikström, Ingrid AU - Enroth, Stefan AU - Williamson, Anna-Lise AU - Olovsson, Matts AU - Gyllensten, Ulf AB - Abstract Background The indicating FTA card is a dry medium used for collection of cervical samples. HPVIR is a multiplex real-time PCR test that detects 12 high-risk human papillomavirus types (hrHPV) and provides single genotype information for HPV16, − 31, − 35, − 39, − 51, − 56, and − 59 and pooled type information for HPV18/45 and HPV33/52/58. The aim of this study was to evaluate whether a strategy with cervical samples collected on the FTA card and subsequently analysed with the HPVIR test complies with the criteria of the international guidelines for a clinically validated method for cervical screening. Methods We performed a non-inferiority test comparing the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a clinically validated reference test (Cobas® HPV test) based on liquid-based cytology (LBC) samples. Two clinical samples (LBC and FTA) were collected from 896 participants in population-based screening. For evaluation of the specificity we used 799 women without ≥ CIN2, and for clinical sensitivity we used 67 women with histologically confirmed ≥ CIN2. The reproducibility was studied by performing inter- and intra-laboratory tests of 558 additional clinical samples. Results The clinical sensitivity and specificity for samples collected on the FTA card and analysed using the HPVIR test were non-inferior to samples analysed with the Cobas® HPV test based on LBC samples (non-inferiority test score, p = 1.0 × 10− 2 and p = 1.89 × 10− 9, respectively). Adequate agreement of > 87% was seen in both the intra- and inter-laboratory comparisons. Conclusions Samples collected on the indicating FTA card and analysed with HPVIR test fulfil the requirements of the international guidelines and can therefore be used in primary cervical cancer screening. DA - 2019-08-22 DB - OpenUCT DP - University of Cape Town KW - HPV KW - DNA testing KW - Primary cervical cancer screening KW - International guidelines LK - https://open.uct.ac.za PY - 2019 T1 - Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening TI - Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening UR - http://hdl.handle.net/11427/30701 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12985-019-1216-7
dc.identifier.urihttp://hdl.handle.net/11427/30701
dc.identifier.vancouvercitationGustavsson I, Aarnio R, Myrnäs M, Hedlund-Lindberg J, Taku O, Meiring T, et al. Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening. 2019; http://hdl.handle.net/11427/30701.en_ZA
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.subjectHPV
dc.subjectDNA testing
dc.subjectPrimary cervical cancer screening
dc.subjectInternational guidelines
dc.titleClinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening
dc.typeJournal Article
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