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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005120naa a2200493 4500
001oai:DiVA.org:uu-394268
003SwePub
008191009s2019 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3942682 URI
0247 a https://doi.org/10.1186/s12985-019-1216-72 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Gustavsson, Inger M.u Uppsala universitet,Science for Life Laboratory, SciLifeLab,Medicinsk genetik och genomik4 aut0 (Swepub:uu)ingergus
2451 0a 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
264 c 2019-08-22
264 1b Springer Science and Business Media LLC,c 2019
338 a electronic2 rdacarrier
520 a BackgroundThe 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.MethodsWe 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.ResultsThe 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.ConclusionsSamples 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Mikrobiologi inom det medicinska området0 (SwePub)301092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Microbiology in the medical area0 (SwePub)301092 hsv//eng
653 a HPV
653 a DNA testing
653 a Primary cervical cancer screening
653 a International guidelines
7001 a Aarnio, Riina,d 1971-u Uppsala universitet,Reproduktionsbiologi4 aut0 (Swepub:uu)riiaa788
7001 a Myrnäs, Mattiasu Uppsala universitet,Reproduktionsbiologi,Uppsala Univ, Dept Womens & Childrens Hlth, SE-75185 Uppsala, Sweden4 aut
7001 a Lindberg, Julia Hedlundu Uppsala universitet,Science for Life Laboratory, SciLifeLab,Medicinsk genetik och genomik4 aut0 (Swepub:uu)julin226
7001 a Taku, Ongeziweu Univ Cape Town, Fac Hlth Sci, Div Med Virol, Anzio Rd, ZA-7925 Cape Town, South Africa4 aut
7001 a Meiring, Tracyu Univ Cape Town, Fac Hlth Sci, Div Med Virol, Anzio Rd, ZA-7925 Cape Town, South Africa4 aut
7001 a Wikström, Ingrid,d 1949-u Uppsala universitet,Reproduktionsbiologi4 aut0 (Swepub:uu)ingrwiks
7001 a Enroth, Stefan,d 1976-u Uppsala universitet,Science for Life Laboratory, SciLifeLab,Medicinsk genetik och genomik4 aut0 (Swepub:uu)stenr451
7001 a Williamson, Anna-Liseu Univ Cape Town, Fac Hlth Sci, Div Med Virol, Anzio Rd, ZA-7925 Cape Town, South Africa4 aut
7001 a Olovsson, Matts,d 1958-u Uppsala universitet,Reproduktionsbiologi4 aut0 (Swepub:uu)mattolov
7001 a Gyllensten, Ulf B.u Uppsala universitet,Science for Life Laboratory, SciLifeLab,Medicinsk genetik och genomik4 aut0 (Swepub:uu)ulfgyll
7102 a Uppsala universitetb Science for Life Laboratory, SciLifeLab4 org
7730 t Virology Journald : Springer Science and Business Media LLCg 16:1q 16:1x 1743-422X
8564 u https://doi.org/10.1186/s12985-019-1216-7y Fulltext
8564 u https://uu.diva-portal.org/smash/get/diva2:1359407/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 u https://virologyj.biomedcentral.com/track/pdf/10.1186/s12985-019-1216-7
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-394268
8564 8u https://doi.org/10.1186/s12985-019-1216-7

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