Analytical performance evaluation and HPV genotype-specific concordance between EUROarray HPV and HPV 3.5 LCD-Array Kit in 163 German cervical samples

Introduction:

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.

Methods:

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.

Results:

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).

Conclusion:

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.