Performance of a New HPV Cervi-Collect Collection and Transportation Kit

الملخص EN

Background.

Liquid-based Pap (L-Pap) media are used for Pap and human papillomavirus (HPV) testing.

Objectives.

To compare RealTime High Risk (HR) HPV testing of a new collection kit (Cervi-Collect) and PreservCyt L-Pap specimens.

To determine ease of use and safety of Cervi-Collect.

Methods.

L-Pap samples (n=203) were tested with HC2 and RealTime HR HPV and Cervi-Collect with RealTime HR HPV.

Discordant samples were genotyped.

Results.

L-Pap and Cervi-Collect specimens tested by RealTime HR HPV showed 93.1% agreement (Kappa 0.86).

RealTime HR HPV and HC2 on L-Pap had 90.3% agreement (Kappa 0.80).

RealTime HR HPV on Cervi-Collect and HC2 on L-Pap showed 88.2% agreement (Kappa 0.76).

Sixteen of 21 samples which were HC2 negative and RealTime HR HPV positive on L-Pap or Cervi-Collect contained HR HPV genotypes.

Eleven healthcare collectors were in strong agreement on a usability and safety questionnaire.

Conclusion.

Cervi-Collect samples were easy to collect and showed strong agreement with L-Pap samples tested with RealTime HR HPV or HC2.