Ulf Gyllensten (Sweden)
Uppsala University Department of Immunology, Genetics, and PathologyPresenter of 2 Presentations
CERVICAL SAMPLES APPLIED TO FTA CARD ANALYSED WITH HPVIR TEST COMPLIES WITH THE INTERNATIONAL GUIDELINES FOR HPV TEST TO BE USED IN CERVICAL CANCER SCREENING (ID 309)
- Inger Gustavsson (Sweden)
- Riina Aarnio Aarnio (Sweden)
- Mattias Myrnäs (Sweden)
- Julia Hedlund-Lindberg (Sweden)
- Ongeziwe Taku (South Africa)
- Meiring L. Tracy (South Africa)
- Ingrid Wikström (Sweden)
- Stefan Enroth (Sweden)
- Anna-Lise Williamson (South Africa)
- Matts Olovsson (Sweden)
- Ulf Gyllensten (Sweden)
Abstract
Introduction
The collection of the cervix is mainly based on cells suspended in liquid-based media (LBC). In several studies, it has been proven that LBC analysed with Cobas® HPV test meets the criteria of the international guidelines for clinical validation. The indicating FTA card is a dry medium in which applied cervical cells are kept stable at room temperature. HPVIR is a multiplex real-time PCR test that detects and quantifies 12 high-risk HPV. The purpose of this study was to evaluate whether a strategy with cervical specimens collected on the FTA card and subsequently analysed with HPVIR test meets the criteria of the international guidelines for a clinically validated method of cervical cancer screening.
Methods
A non-inferiority test was used to compare the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a reference test (Cobas® HPV test) based on LBC samples. Two clinical samples (LBC and FTA) were collected from 896 participants in population-based screening. We evaluated the clinical specificity in 799 women without ≥ CIN2, and the clinical sensitivity in 67 women with histologically confirmed ≥ CIN2. The reproducibility was studied by performing inter- and intra-laboratory tests of 558 additional clinical samples of which 51% previously tested HPV positive.
Results
The clinical sensitivity and specificity for samples collected on the FTA card and analysed with HPVIR test were non-inferior to the reference test (non-inferiority test score, p = 1.0 x 10-2 and p = 1.89 x 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.