Concordant testing results between various human papillomavirus assays in primary cervical cancer screening: systematic review.

OBJECTIVES: Human papillomavirus (HPV) assays are increasingly used for primary cervical screening and HPV-vaccination-effect monitoring. We undertook a systematic literature review to determine the concordance in positive test results (i.e. detection of HPV infections) between Hybrid Capture 2 (HC2) and other assays. METHODS: We searched PubMed, Embase and Scopus for studies of primary screening with HC2 and one or more assays, with cross-tabulated testing results for the assays. Two authors applied inclusion criteria and three authors extracted data from included studies. For each inter-assay comparison, we calculated the concordance by comparing the number of concordant samples with the number of samples that tested positive on at least one assay. RESULTS: Sixteen studies fulfilled inclusion criteria, comparing nine assays to HC2, and including 392 to 9451 patients each. The calculated concordance varied between 48% and 69% for HC2 and APTIMA, Cobas, Abbott RealTime, Cervista, GP5+/6+, CLART, BD HPV test, Amplicor and Linear Array, i.e. 31%-52% of all positive tests on any pair of compared assays were discordant. Although modest variation in the degree of concordance with HC2 was suggested for particular assays, the numbers of studies per assay were generally low. No pronounced systematic patterns were observed by study (e.g. liquid medium) or population characteristics. CONCLUSIONS: The ten commercially available assays do not detect the same HPV infections. Even in the most favourable case, the two assays provided discordant test results in 31% of all detected infections.

High-grade cervical intraepithelial neoplasia in human papillomavirus self-sampling of screening non-attenders.

BACKGROUND: Self-sampling for human papillomavirus (HPV) offered to women who do not participate in cervical cancer screening is an increasingly popular method to increase screening coverage. The rationale behind self-sampling is that unscreened women harbour a high proportion of undetected precancer lesions. Here, we compare the cervical intraepithelial neoplasia grade 2 or worse (⩾CIN2) detection rate between non-attenders who participated in self-sampling and women attending routine screening. METHODS: A total of 23 632 women who were qualified as non-attenders in the Copenhagen Region were invited for HPV-based self-sampling. Of these, 4824 women returned a self-sample, and HPV-positive women were referred for cytology and HPV co-testing as follow-up. The entire cohort and a reference cohort (3347 routinely screened women) were followed for histopathology confirmed ⩾CIN2. Odds ratio (OR) and the relative positive predictive value of ⩾CIN2 detection between the two populations were estimated. RESULTS: Women participating in self-sampling had a higher ⩾CIN2 detection than women undergoing routine cytology-based screening (OR=1.83, 95% CI: 1.21-2.77) and a similar detection as routinely screened women tested with cytology and HPV testing (OR=1.03, 95% CI: 0.75-1.40). The positive predictive value for ⩾CIN2 was higher in screening non-attenders than in routinely HPV- and cytology-screened screened women (36.5% vs 25.6%, respectively). CONCLUSIONS: Self-sampling offered to non-attenders showed higher detection rates for ⩾CIN2 than routine cytology-based screening, and similar detection rates as HPV and cytology co-testing. This reinforces the importance of self-sampling for screening non-attenders in organised cervical cancer screening.

Prevalence of Human Papillomavirus in Self-Taken Samples from Screening Nonattenders.

The Copenhagen Self-Sampling Initiative (CSi) has shown how human papillomavirus (HPV)-based self-sampling can be used to increase screening participation among 23,632 nonattenders in the Capital Region of Denmark. In this study, we describe HPV prevalence and genotype frequency in 4,824 self-samples as determined by three HPV assays (the CLART, Onclarity, and Hybrid Capture 2 [HC2] assays) and compare the results with those for physician-taken follow-up samples. The HPV self-sample findings were also compared to the findings for a reference population of 3,347 routinely screened women from the Horizon study, which had been undertaken in the same screening laboratory. Nonattenders had an HPV prevalence of 11.3% as determined by the CLART assay, which was lower than that for women from the Horizon study (18.5%). One-third of the CSi women who tested HPV positive by self-sampling tested HPV negative on the physician-taken follow-up sample. The CLART and Onclarity assays agreed on 64% (95% confidence interval [CI], 60 to 68%) of the HPV-positive self-taken samples. When the HC2 assay results were added into a three-way comparison, the level of agreement decreased to 27% (95% CI, 24 to 29%). Our findings suggest that further validation of HPV assays on self-taken samples is needed for optimal HPV detection and correct clinical management of HPV-positive women.