The introduction of Human Papillomavirus (HPV) testing in cervical cancer screening enhanced the opportunity to introduce self-collection as an innovative approach to improve coverage rates. Validation and standardization of the pre-analytical and analytical procedures are crucial for the quality assurance of HPV tests on self-collected samples. This study evaluated the analytical performance and the stability of self-collected vaginal samples resuspended in 5 mL of two non-alcohol-based media, eNat® and MSwab® compared to a professionally collected cervical sample, resuspended in 20 mL ThinPrep®, for the detection of high-risk HPV (hrHPV). The impact of the suspension volumes on analytical performance was also evaluated (2 and 5 ml). A good analytical concordance in hrHPV detection in cervical and vaginal self-collected swabs suspended in 5 ml of both non-alcohol-based media was demonstrated (eNat®: 91.2 %, k = 0.821; MSwab®: 91.4 %; k = 0.798). A similar analytical performance was found for samples resuspended in 2 mL (eNat®: 92.9 %, k = 0.811; MSwab®: 92.9 %, k = 0.811) compared to cervical samples. Good nucleic acid stability was demonstrated for vaginal samples stored at 20-25 °C and 37 °C for up to 4 weeks. Results of this preliminary study support the introduction of these media for vaginal self-sampling-based prevention programs. Nevertheless, further research is necessary to evaluate clinical accuracy in larger settings.

Giubbi, C., Martinelli, M., Di Meo, M., Njoku, R., Perdoni, F., Fruscio, R., et al. (2024). Evaluation of two alternative non-alcohol-based media for the suspension of self-collected vaginal swabs for HPV testing in cervical cancer screening. HELIYON, 10(10 (30 May 2024)) [10.1016/j.heliyon.2024.e31032].

Evaluation of two alternative non-alcohol-based media for the suspension of self-collected vaginal swabs for HPV testing in cervical cancer screening

Giubbi, Chiara
Primo
;
Martinelli, Marianna
Secondo
;
Di Meo, Maria Letizia;Perdoni, Federica;Fruscio, Robert;Landoni, Fabio
Penultimo
;
Cocuzza, Clementina Elvezia
Ultimo
2024

Abstract

The introduction of Human Papillomavirus (HPV) testing in cervical cancer screening enhanced the opportunity to introduce self-collection as an innovative approach to improve coverage rates. Validation and standardization of the pre-analytical and analytical procedures are crucial for the quality assurance of HPV tests on self-collected samples. This study evaluated the analytical performance and the stability of self-collected vaginal samples resuspended in 5 mL of two non-alcohol-based media, eNat® and MSwab® compared to a professionally collected cervical sample, resuspended in 20 mL ThinPrep®, for the detection of high-risk HPV (hrHPV). The impact of the suspension volumes on analytical performance was also evaluated (2 and 5 ml). A good analytical concordance in hrHPV detection in cervical and vaginal self-collected swabs suspended in 5 ml of both non-alcohol-based media was demonstrated (eNat®: 91.2 %, k = 0.821; MSwab®: 91.4 %; k = 0.798). A similar analytical performance was found for samples resuspended in 2 mL (eNat®: 92.9 %, k = 0.811; MSwab®: 92.9 %, k = 0.811) compared to cervical samples. Good nucleic acid stability was demonstrated for vaginal samples stored at 20-25 °C and 37 °C for up to 4 weeks. Results of this preliminary study support the introduction of these media for vaginal self-sampling-based prevention programs. Nevertheless, further research is necessary to evaluate clinical accuracy in larger settings.
Articolo in rivista - Articolo scientifico
Cervical cancer; HPV; HPV testing; Human papillomavirus; Self-sampling; Suspension medium;
English
11-mag-2024
2024
10
10 (30 May 2024)
e31032
none
Giubbi, C., Martinelli, M., Di Meo, M., Njoku, R., Perdoni, F., Fruscio, R., et al. (2024). Evaluation of two alternative non-alcohol-based media for the suspension of self-collected vaginal swabs for HPV testing in cervical cancer screening. HELIYON, 10(10 (30 May 2024)) [10.1016/j.heliyon.2024.e31032].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/478819
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