A comparison of ThinPrep against four non-volatile transport media for HPV testing at or near the point of care.

The Xpert HPV Test is used at point of care for cervical screening in a number of low and middle income countries (LMIC). It is validated for use with ThinPrep-PreservCyt transport medium which has a high methanol content and is therefore classified as a dangerous good for shipping, making cost, transportation and use challenging within LMIC. We compared the performance of ThinPrep against four non-volatile commercially available media for human papillomavirus (HPV) point of care testing. Ten-fold serial dilutions were prepared using three HPV cell lines each positive for 16, 18 or 31 and with each suspended in five different media types. The media types consisted of Phosphate Buffered Saline (ThermoFisher Scientific, USA), Sigma Virocult (Medical Wire and Equipment, UK), MSwab (Copan, Italy) Xpert Transport Media (Cepheid, USA) and ThinPrep-PreservCyt (Hologic, USA). A total of 105 Xpert HPV tests were conducted in a laboratory setting, with seven 10-fold dilutions of each of the three HPV genotypes tested in all five media types. The lowest HPV 10-fold dilution detected for any media, or cell line was the fifth dilution. MSwab was the only medium to detect HPV to the fifth dilution across all three cell types. MSwab transport media may be a suitable alternative to ThinPrep for Xpert HPV point of care testing. A field based, head to head comparison of both media types using the Xpert HPV assay is warranted to confirm these laboratory based findings.

Anyplex II HPV28 detection and Anyplex II HPV HR detection assays are highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities.

PURPOSE: to evaluate the performance of Anyplex II HPV28 and HPV HR Detection assays against the EuroArray HPV, Cobas 4800 HPV (Cobas), HPV Amplicor (Amp), Linear Array HPV (LA) and Hybrid Capture 2 (HC2) in detection of high-risk HPV (HR-HPV) from liquid-based cervical cytology samples. METHODS: cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by Anyplex II HPV28 and HPV HR Detection assays for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to EuroArray, HC2, Cobas, Amp, and LA. RESULTS: specimens were evaluated from 404 women with an average age of 30 years, including 336 with a histological diagnosis of ≥ CIN2 and 68 with ≤ CIN1. Concordance of HR-HPV detection between Anyplex II HPV28 and other genotyping assays was 94.79 % (κ = 0.84; EuroArray) and 97.27 % (κ = 0.91; LA); and between Anyplex II HPV HR and other HR-HPV detection assays was 86.35 % (κ = 0.62; HC2), 96.03 % (κ = 0.87; Cobas) and 96.77 % (κ = 0.89; Amp). Using HR-HPV detection for prediction of ≥ CIN2 by Anyplex II HPV28 and HPV HR, sensitivity (90.18, 95 % CI 86.48-93.14; 90.77, 95 % CI 87.16-93.65) and specificity (both 67.16, 95 % CI 54.60-78.15) were not significantly different to the other HPV assays tested, with one exception. Both Anyplex assays had significantly higher sensitivity than HC2 (p < 0.0001), with a specificity of 96 % (p > 0.05) of HC2 in this high-risk population. CONCLUSIONS: both Anyplex II HPV detection assays were concordant with other commercial assays for HR-HPV detection, with comparable sensitivity and specificity for ≥ CIN2 detection.

Comparison of the Roche Cobas® 4800 HPV assay to Roche Amplicor for detection of high-risk human papillomavirus.

UNLABELLED: Roche Amplicor HPV (AMP) had previously been used for detection of high-risk human papillomavirus (HR-HPV) in epidemiological and clinical studies. As this assay is no longer available, we compared its performance using PreservCyt samples from women aged of 18-24 years attending for routine cervical cytology screening to Roche Cobas® 4800 (Cobas) to determine if subsequent studies could continue using the Cobas assay. Overall 507 samples were tested on Cobas and compared to previous AMP results, with discrepant samples tested on Roche Linear Array. RESULTS: Overall, agreement between the Cobas and AMP for the presence of HR HPV types was very high (κ = 0.81) (95 % CI: 0.76 - 0.87) with percentage agreement of 91.57 %. Cobas is comparable to AMP for the detection of HR-HPV types in a community recruited cohort of healthy women.

EUROarray human papillomavirus (HPV) assay is highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities.

The purpose of this study was to evaluate the performance of the EUROIMMUN EUROArray HPV genotyping assay against the Roche Cobas 4800, Roche HPV Amplicor, Roche Linear Array and Qiagen Hybrid Capture 2 assays in the detection of high-risk HPV (HR-HPV) from liquid based cervical cytology samples collected from women undergoing follow-up for abnormal cervical cytology results. Cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by EUROarray HPV for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to Hybrid Capture 2, Cobas 4800 HPV, Amplicor and Linear Array HPV. Positivity for 14 HR-HPV types was 80.0 % for EUROarray (95 % CI; 75.7-83.8 %). Agreement (κ, 95 % CI) between the EUROarray and other HPV tests for detection of HR-HPV was good to very good [Hybrid Capture κ = 0.62 (0.54-0.71); Cobas κ = 0.81 (0.74-0.88); Amplicor κ = 0.68 (0.60-0.77); Linear Array κ = 0.77 (0.70-0.85)]. For detection of HR-HPV, agreement with EUROarray was 87.90 % (Hybrid Capture), 93.58 % (Cobas), 92.84 % (Amplicor) and 92.59 % (Linear Array). Detection of HR-HPV was not significantly different between EUROarray and any other test (p < 0.001). EUROarray was concordant with other assays evaluated for detection of high-risk HPV and showed sensitivity and specificity for detection of ≥ CIN2 of 86 % and 71 %, respectively.

How to best measure the effectiveness of male human papillomavirus vaccine programmes?

In many countries now, vaccination of young adolescent girls with prophylactic human papillomavirus (HPV) vaccines has been rolled out as a public health programme. In countries where coverage has been high, this has led to dramatic reductions in cervical high-grade precancerous lesions, as well as genital warts. A reduction in circulating vaccine-related HPV types has also been demonstrated. With the introduction of gender-neutral approaches incorporating universal vaccination of pre-adolescent boys in some countries, implementation of post-vaccine monitoring will be critical to evaluate the incremental impact of male vaccination. In contrast to cervical screening programmes, population-wide screening for HPV infection or related disease in males is not recommended; hence real-time monitoring of HPV vaccine effectiveness in males will require dedicated surveillance strategies. Monitoring the prevalence of circulating genital HPV types using a sentinel surveillance model could offer a good surrogate marker of early vaccine effectiveness in males. However, such an approach requires careful consideration of the most appropriate anatomical sites from which to collect specimens, the best sampling methods and the most sensitive assays to use. Additionally, in assessing an accurate measure of the impact of HPV vaccination in the male population, the effect of herd protection will need to be assessed, as most male programmes will commence in the setting of established female programmes. This poses an interesting epidemiological challenge.