Clinical validation of the Roche cobas and cobas 4800 HPV tests on self-collected vaginal dry swabs vs practitioner-collected cervical specimens using the VALHUDES Protocol.

Authors

David Hawkes, Desuba Gurung, Eunice Pineda, Alvin Lee, Joanne Romano, Marco Ho Ting Keung, Julie Silvers, Angela Steele, Yasmin Jayasinghe, Julia M L Brotherton, Marc Arbyn, C David Wrede, Marion Saville

Published in

The Journal of molecular diagnostics : JMD. Jun 19, 2026. Epub Jun 19, 2026.

Abstract

The first national HPV-based cervical screening programs began in 2017. Since then, a growing list of countries have moved, or want to move, to HPV-based screening. One of the benefits of HPV-based screening is that a sample does not need to be collected from the cervix by a healthcare practitioner. Self-collection has been demonstrated to give equivalent accuracy as practitioner-collected specimens when a PCR-based clinically validated HPV assay is used. However, there are few clinically validated, PCR-based, HPV assays with on-label claims for self-collection. The current study, Self-Collection or Practitioner-collection Evaluation 2 (SCoPE2), undertook a VALHUDES protocol evaluation with individuals recruited in a colposcopy population in the context of an HPV-based screening program. SCoPE2 recruited 400 participants who each took a self-collected vaginal sample using a FLOQSwab. A practitioner-collected cervical sample was then collected at colposcopy. HPV testing was performed using both the cobas 4800 and the cobas HPV tests. The self-collected specimens demonstrated equivalent and non-inferior relative sensitivity for histologically confirmed CIN2+ (n = 58) when compared with the practitioner-collected specimen for both the cobas 4800 (0.982) and cobas (1.037), but relative specificity was inferior. Additional analyses were undertaken to resolve referral, self-, and practitioner-collected discordant results. SCoPE2 demonstrates that the assessed self-collection method is non-inferior for the detection of CIN2+ when compared with a practitioner-collected specimen.

PMID:
42320756
Bibliographic data and abstract were imported from PubMed on 20 Jun 2026.

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