BackgroundHPV‐based cervical screening detects women at an increased risk of cervical cancer and precancer. To differentiate among HPV‐positive women those with (pre)cancer, triage testing is necessary. The detection of cancer‐associated host‐cell DNA methylation (FAM19A4 and hsa‐mir124‐2) in cervical samples has shown valuable as triage test. This multicenter study from 6 collaborating European laboratories and one reference laboratory was set out to determine the intra‐ and inter‐laboratory agreement of FAM19A4/mir124‐2 DNA methylation analysis utilizing the QIAsure Methylation Test.MethodsAgreement analysis for the QIAsure Methylation Test was assessed on high‐risk HPV‐positive cervical specimens (n = 1680) both at the level of the assay and at the full workflow, including bisulfite conversion.ResultsIntra‐ and inter‐laboratory assay agreement were 91.4% (534/584; 95% CI 88.9‐93.5; κ = 0.82) and 92.5% (369/399; 95% CI 90.0‐94.7; κ = 0.83), respectively. The inter‐laboratory workflow (bisulfite conversion and assay combined) agreement was 90.0% (627/697; 95% CI 87.5%‐92.0%; κ = 0.76).ConclusionThese data show that the QIAsure Methylation Test performs robust and reproducible in different laboratory contexts. These results support the use of the QIAsure Methylation Test for full molecular screening for cervical cancer, including primary HPV testing and triage testing by methylation analysis.

BackgroundDespite the increasing incidence of laryngeal squamous cell carcinoma (LSCC) in Algeria, scarce information is available on the importance of the preventable etiological factors which may drive the disease. Remarkably, a significant number of cases occur in nonsmoker and nondrinker patients; hence, suggesting that alternative risk factors, like Human papillomavirus (HPV), might be etiologically involved. To gain more insight on the risk factors associated with the disease in the country, we evaluated the etiological fraction of HPV in comparison to tobacco and alcohol intake in LSCC patients.MethodsTo evaluate the etiopathologic fraction (EF) for HPV compared to history of tobacco and alcohol in LSCC, HPV DNA presence in 46 invasive and 3 non-invasive formalin-fixed paraffin-embedded laryngeal tumors was screened using the SPF10-DEIA-LiPA25 Assay. Demographic data and information related to exposure to the risk factors were gathered through interviewer-assisted questionnaires.ResultsWe observed that 40.8% of all LSCC cases were associated with smoking, 40.8% had combined tobacco and alcohol exposure history, and 14.3% did not show prior exposure to either risk factor. 1 out of 3 in-situ carcinoma cases was positive for HPV-6. HPV prevalence was null in the invasive tumors. HPV DNA was detected in 2.38% for all studied cases. 10.2% of LSCC patients did not associate with any of the studied risk factors.ConclusionHere we show that HPV etiological fraction in LSCC Algerian patients is low and smoking and alcohol remain the principal etiopathologic risk for LSCC burden in Algeria.