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Home > Biblio > Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol.

Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol.

Ziekten en gezondheid in kaart brengen  

Peer reviewed scientific article

Engels

SCIENSANO

Auteurs

Ardashel Latsuzbaia [1]; Severien Van Keer [2]; Vanden Broeck, Davy [3]; Weyers, Steven [4]; Gilbert Donders [5]; Philippe De Sutter [6]; Wiebren Tjalma [7]; Jean Doyen [8]; Alex Vorsters [9]; M. Arbyn [10]

Trefwoorden

  1. Early Detection of Cancer [11]
  2. Female [12]
  3. Human Papillomavirus Viruses [13]
  4. Humans [14]
  5. Papillomaviridae [15]
  6. Papillomavirus Infections [16]
  7. Sensitivity and Specificity [17]
  8. specimen handling [18]
  9. Uterine Cervical Dysplasia [19]
  10. Uterine Cervical Neoplasms [20]
Article written during project(s) : 
VALHUDES VALidation of HUman papillomavirus assays and collection DEvices for HPV testing on Self-samples and urine samples (VALHUDES) [21]

Samenvatting:

The VALHUDES protocol was established to evaluate clinical accuracy of human papillomavirus (HPV) assays to detect cervical precancer on first-void urine (FVU) and vaginal self-samples versus matched clinician-collected cervical samples (CCSs). Here we evaluated clinical performance of Alinity m HR HPV assay in a colposcopy referral population. Home-collected FVU (Colli-Pee FV 5020) 1 day before colposcopy (n = 492), at-clinic collected dry vaginal self-samples [multi-Collect Swab (mC; n = 493), followed by Evalyn Brush (EB; n = 233) or Qvintip (QT; n = 260)] and matched CCSs, were availabl…
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Samenvatting

The VALHUDES protocol was established to evaluate clinical accuracy of human papillomavirus (HPV) assays to detect cervical precancer on first-void urine (FVU) and vaginal self-samples versus matched clinician-collected cervical samples (CCSs). Here we evaluated clinical performance of Alinity m HR HPV assay in a colposcopy referral population. Home-collected FVU (Colli-Pee FV 5020) 1 day before colposcopy (n = 492), at-clinic collected dry vaginal self-samples [multi-Collect Swab (mC; n = 493), followed by Evalyn Brush (EB; n = 233) or Qvintip (QT; n = 260)] and matched CCSs, were available for the study. Sensitivity to detect cervical intraepithelial neoplasia grade 2 or higher (CIN2) of Alinity testing on FVU (ratio, 0.94; 95% CI, 0.85-1.03), mC (ratio, 1.00; 95% CI, 0.94-1.06), and EB/QT (ratio, 0.92; 95% CI, 0.85-1.00) was not different to CCSs. Specificity on FVU was similar to CCS (ratio, 1.02; 95% CI, 0.95-1.10), whereas specificity on mC was lower (ratio, 0.83; 95% CI, 0.76-0.90), but on EB/QT was higher (ratio, 1.08; 95% CI, 1.01-1.15) than on CCS. Accuracy on EB (sensitivity ratio, 0.96; 95% CI, 0.87-1.05; specificity ratio, 1.18; 95% CI, 1.06-1.31) was slightly better than on QT (sensitivity ratio, 0.88; 95% CI, 0.75-1.03; specificity ratio, 1.00; 95% CI, 0.92-1.09). In conclusion, clinical sensitivity of Alinity assay on all self-sample types was similar to cervical specimens. Adjustment of signal thresholds improved assay's accuracy to detect CIN2 in all self-sample types.

Associated health topics:

Humaan papillomavirus (hpv) en baarmoederhalskanker [22]

Source URL:https://www.sciensano.be/nl/biblio/clinical-accuracy-alinity-m-hr-hpv-assay-self-versus-clinician-taken-samples-using-valhudes-protocol

Links
[1] https://www.sciensano.be/nl/people/ardashel-latsuzbaia/biblio [2] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=185199&f%5Bsearch%5D=Severien%20Van%20Keer [3] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=52821&f%5Bsearch%5D=Vanden%20Broeck%2C%20Davy [4] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=52824&f%5Bsearch%5D=Weyers%2C%20Steven [5] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=185195&f%5Bsearch%5D=Gilbert%20Donders [6] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=185196&f%5Bsearch%5D=Philippe%20De%20Sutter [7] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=186371&f%5Bsearch%5D=Wiebren%20Tjalma [8] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=185197&f%5Bsearch%5D=Jean%20Doyen [9] https://www.sciensano.be/nl/biblio?f%5Bauthor%5D=185200&f%5Bsearch%5D=Alex%20Vorsters [10] https://www.sciensano.be/nl/people/marc-arbyn/biblio [11] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33630&f%5Bsearch%5D=Early%20Detection%20of%20Cancer [12] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=2685&f%5Bsearch%5D=Female [13] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=38138&f%5Bsearch%5D=Human%20Papillomavirus%20Viruses [14] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=648&f%5Bsearch%5D=Humans [15] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33579&f%5Bsearch%5D=Papillomaviridae [16] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33132&f%5Bsearch%5D=Papillomavirus%20Infections [17] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=2547&f%5Bsearch%5D=Sensitivity%20and%20Specificity [18] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=5463&f%5Bsearch%5D=specimen%20handling [19] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=33633&f%5Bsearch%5D=Uterine%20Cervical%20Dysplasia [20] https://www.sciensano.be/nl/biblio?f%5Bkeyword%5D=32811&f%5Bsearch%5D=Uterine%20Cervical%20Neoplasms [21] https://www.sciensano.be/nl/projecten/validation-human-papillomavirus-assays-and-collection-devices-hpv-testing-self-samples-and-urine [22] https://www.sciensano.be/nl/gezondheidsonderwerpen/humaan-papillomavirus-hpv-en-baarmoederhalskanker