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Analytical performance evaluation and HPV genotype-specific concordance between EUROarray HPV and HPV 3.5 LCD-Array Kit in 163 German cervical samples
20 September 2018 (online)
The purpose of this study was to evaluate the performance of the EUROArray HPV genotyping assay (Euroimmun) against the HPV 3.5 LCD-Array Kit (Chipron) from liquid based cervical cytology samples clinician collected from women undergoing cervical inspection at the dysplasia consultation.
DNA extracted from clinician-collected cervical brush specimens from 163 German women were evaluated by EUROarray HPV and HPV 3.5 LCD-Array Kit for detection of HR (high-risk)- and LR (low-risk)-HPV genotypes.
Genotype-specific agreements were assessed by Cohen's kappa statistic and Fisher's z-test of significance between proportions.
Positivity for 17 HR-HPV types was 42.3% for EUROarray and 38.0% for HPV 3.5 LCD-Array. Agreement between the EUROarray and the HPV 3.5 LCD-Array for detection of HR-HPV was very good (κ= 0.83). For detection of HR-HPV, agreement with EUROarray was 92.0%. Identical genotypes of HR-HPV were detected in 50 of 72 samples with any detected HR-HPV (81.9%, κ= 0.47). EUROarray genotyping for HPV16 and/or 18 was highly concordant with Chipron (relative agreement 96.3%, κ= 0.88).
Detection of HR-HPV was not significantly different between EUROarray and HPV 3.5 LCD-Array. EUROarray was highly concordant with the HPV 3.5 LCD-Array evaluated for detection of high-risk HPV.