HPV genotype-specific concordance between EuroArray HPV, Anyplex II HPV28 and Linear Array HPV Genotyping test in Australian cervical samples

Abstract

PurposeTo compare human papillomavirus genotype-specific performance of two genotyping assays, Anyplex II HPV28 (Seegene) and EuroArray HPV (EuroImmun), with Linear Array HPV (Roche).MethodsDNA extracted from clinican-collected cervical brush specimens in PreservCyt medium (Hologic), from 403 women undergoing management for detected cytological abnormalities, was tested on the three assays. Genotype-specific agreement were assessed by Cohen's kappa statistic and Fisher's z-test of significance between proportions.ResultsAgreement between Linear Array and the other 2 assays was substantial to almost perfect (κ = 0.60 − 1.00) for most genotypes, and was almost perfect (κ = 0.81 – 0.98) for almost all high-risk genotypes. Linear Array overall detected most genotypes more frequently, however this was only statistically significant for HPV51 (EuroArray; p = 0.0497), HPV52 (Anyplex II; p = 0.039) and HPV61 (Anyplex II; p=0.047). EuroArray detected signficantly more HPV26 (p = 0.002) and Anyplex II detected more HPV42 (p = 0.035) than Linear Array. Each assay performed differently for HPV68 detection: EuroArray and LA were in moderate to substantial agreement with Anyplex II (κ = 0.46 and 0.62, respectively), but were in poor disagreement with each other (κ = −0.01).ConclusionsEuroArray and Anyplex II had similar sensitivity to Linear Array for most high-risk genotypes, with slightly lower sensitivity for HPV 51 or 52.

Validation of EUROArray HPV test using the VALGENT framework

“…In a recent study, Cornall et al(2016) demonstrated that clinical sensitivity and specificity of EUROArray HPV was similar to a number of HPV tests including HC2 [18] and was non-inferior to HC2 in terms of sensitivity. However, that study focussed on a disease-enriched population of 404 women of which 336 had CIN2+.…”

“…EUROArray HPV enables the simultaneous detection of 30 different anogenital HPVs in a single reaction through the PCR amplification of fragments of E6 and E7 viral oncogenes. As EUROArray HPV is a relatively novel test, few data have been published regarding its clinical performance [18] and none where performance has been related to the Meijer 2009 criteria.…”

“…EUROArray HPV workflow (EUROIMMUN™) consists of PCR amplification of fragments of E6 and E7 viral oncogenes of 30 different HPV types and detection of type-specific identity via hybridisation with immobilised DNA probes that correspond to the targets within a microarray system [18,19].…”

Evaluation of the Roche MagNA Pure 96 nucleic acid extraction platform for the Seegene Anyplex II HPV28 detection assay

“…The Anyplex28 assay and validated DNA extraction protocol (STARlet) is designed to detect HPV DNA at a sensitivity and specificity threshold to predict grade II cervical intraepithelial neoplasia or greater from female cervical samples. However, HPV DNA detection and genotyping is also vital to monitor the effectiveness of vaccination programmes in the community, requiring assays that detect all HPV DNA from a sample (Cornall et al 2017). The findings presented suggest that the laboratory standard extraction protocol (5-fold increase in sample input) utilizing the Anyplex28 genotyping kit could be considered for research where higher analytical sensitivity is desired, such as in studies of HPV vaccine impact and effectiveness.…”

Prevalence of Human Papillomavirus in Laryngeal Squamous Cell Carcinoma in Azerbaijan Population

“…Different detection method technologies are applied to tissue HPV genotypes analysis, but there is no Food and Drug Administration approved molecular tests to detect HPV infection in HNSCC [12][13][14][15]. There are 193 distinct molecular tests that are commercially available on the global market for the detection of HPV in cervical specimens.…”