Available online 6 July 2021, 200224

The Alinity m HR HPV assay demonstrated very good agreement with ThinPrep and SurePath pre- and post cytology cervical specimens, and between ThinPrep and Alinity Cervi-Collect specimens.

The Alinity m HR HPV assay showed very good agreement with the cobas 4800 HPV assay with ThinPrep and SurePath specimens and identified genotypes 16/18 and other high-risk types simultaneously in a single analysis, similar to the cobas 4800 HPV assay.

The Alinity m HR HPV assay demonstrated strong agreements with cobas 4800 HPV assay for all cytology scoring.

To assess the concordance of hrHPV testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of hrHPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas).

Specimens were obtained from 560 women attending a Women’s Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays.

Alinity showed an agreement of 93.9%, Kappa=0.89 (263/280) between ThinPrep and SurePath specimens; 97.5%, Kappa=0.95 (347/356) and 92.9%, Kappa=0.85 (104/112) between ThinPrep and SurePath aliquots taken before or after cytology processing, respectively. Cervi-Collect specimens showed an agreement of 94.6%, Kappa=0.89 (265/280) with ThinPrep specimens. Compared to cobas, Alinity showed agreements of 94.3%, Kappa=0.88 (395/419) and 91.8%, Kappa=0.82 (257/280) between ThinPrep and SurePath specimens, respectively. Alinity and cobas detected genotypes 16/18 and other high-risk HPV types at similar rates and showed similar correlations with cytology grades.

Compared to cobas, Alinity performed equally well for detecting HPV in cervical specimens obtained with ThinPrep and SurePath. The Cervi-Collect device compared well to the other collection methods. Alinity is a reliable assay for simultaneous detection of HPV-16/18 and other high-risk genotypes in cervical specimens.

Alinity m HR HPV assay

ThinPrep

SurePath and Cervi-Collect cervical specimens

HPV genotype simultaneous detection

Cobas 4800 HPV assay

HPV testing in cervical cancer screening

© 2021 The Author(s). Published by Elsevier B.V.