Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study

Saville, Marion; Hawkes, David; Keung, Mht; Ip, Elo; Silvers, Julie; Sultana, Farhana; Mj, Malloy; Velentzis, LS; Wrede, C. David; Brotherton, Jml

doi:10.1016/j.jcv.2020.104375

Cited by 34 publications

(25 citation statements)

References 36 publications

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“…Our results for VSS cohere with the literature concerning the value of post-therapeutic HPV testing from clinician-collected samples for predicting subsequent outcome among patients treated for high-grade CIN (2,5,(15)(16)(17)(18)(19). Higher positivity rates of VSS compared to clinician-taken samples for overall HPV and HPV16 found herein, were also reported in Reference (20).…”

Section: Discussionsupporting

confidence: 89%

Self‑sampling for high‑risk human papillomavirus as a follow‑up alternative after treatment of high‑grade cervical intraepithelial neoplasia

et al. 2021

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Women treated for high-grade cervical-intraepithelial-neoplasia (CIN) require long-term follow-up with high-risk human-papillomavirus (HPV) testing. Self-sampling for HPV is well-accepted among these patients, but its role in follow-up for this group requires investigation. The present study examined how well HPV findings from self-sampled vaginal (VSS) and urine specimens correctly identified women from this cohort with recurrent CIN2+ compared with samples collected by clinicians. At 1st post-conization follow-up, 531 patients (99.8% participation) gave urine samples, performed VSS, underwent colposcopy with punch biopsy of visible lesions and clinician-collected cervical sampling for HPV analysis and liquid-based cytology. A total of 113 patients with positive HPV and/or abnormal cytology at 1st follow-up underwent 2nd follow-up. At 1st follow-up, all patients with recurrent CIN3 had positive HPV results by all methods. Clinician sampling and VSS revealed HPV16 positivity in 50% of recurrent cases and urine sampling revealed HPV16 positivity in 25% of recurrent cases. At 2nd follow-up, all 7 newly-detected CIN2/3 recurrences were associated with HPV positivity on VSS and clinician-samples. Only clinician-collected samples detected HPV positivity for two adenocarcinoma-in-situ recurrences, and both were HPV18 positive. A total of 77 patients had abnormal cytology at 1st follow-up, for which HPV positivity via VSS yielded highest sensitivity. The HPV findings were positive from VSS in 12 patients with high-grade squamous-intraepithelial-lesions (HSIL), and 11 patients with HSIL had positive HPV findings in clinician-collected and urine samples. All methods for assessing HPV presence yielded significant age-adjusted odds ratios for predicting abnormal lesions at 1st follow-up. For overall HPV results, Cohen's kappa revealed substantial agreement between VSS and clinician sampling, and moderate agreement between urine and clinician sampling. Clinician sampling and VSS were highly concordant for HPV16. Insofar as the pathology was squamous (not glandular), VSS appeared as sensitive as clinician sampling for HPV in predicting outcome among the present cohort. Since VSS can be performed at home, this option can maximize participation in the required long-term follow-up for these women at high-risk.

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Section: Discussionsupporting

confidence: 89%

Self‑sampling for high‑risk human papillomavirus as a follow‑up alternative after treatment of high‑grade cervical intraepithelial neoplasia

et al. 2021

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“…HPV genotyping was performed by Southern Community Laboratories (SCL) using the Abbott Real‐time High‐Risk HPV assay validated by Abbott for cervical swabs 16 . The dry flocked vaginal swab has now been validated with the Abbott assay and is recommended for HPV self‐testing 17 . The Abbott test distinguishes HPV‐16 and HPV‐18 from ‘other’ high‐risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and from negative samples 16…”

Section: Methodsmentioning

confidence: 99%

Reaching under‐screened/never‐screened indigenous peoples with human papilloma virus self‐testing: A community‐based cluster randomised controlled trial

MacDonald

Geller²,

Sibanda

et al. 2020

Aust NZ J Obst Gynaeco

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Background Indigenous women in the high‐income countries of Canada, Australia, New Zealand and USA, have a higher incidence and mortality from cervical cancer than non‐Indigenous women. Increasing cervical screening coverage could ultimately decrease cervical cancer disparities. Aims To increase cervical screening for under‐screened/never‐screened Māori women. Materials and Methods This study was a cluster randomised controlled trial. Inclusion criteria were women aged 25–69, last screened ≥4 years ago, in Northland, New Zealand. The intervention arm was the offer of a human papilloma virus (HPV) self‐test and the control arm was the usual offer of standard care – a cervical smear. The primary outcome was rate of cervical screening in the intervention group compared to control in Māori, the Indigenous peoples of New Zealand. Six primary care clinics were randomly allocated to intervention or control. Results Of 500 eligible Māori women in the intervention arm, 295 (59.0%) were screened. Of 431 eligible Māori women in the control arm, 94 (21.8%) were screened. Adjusting for age, time since last screen, deprivation index, Māori women in the intervention arm were 2.8 times more likely to be screened than women in the control arm (95% CI: 2.4–3.1, P‐value <0.0001). Conclusions Offer of HPV self‐testing could potentially halve the number of under‐screened/never‐screened Māori women and decrease cervical morbidity and mortality. These results may be generalisable to benefit Indigenous peoples facing similar barriers in other high‐income countries.

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“…A recent study examined dry flocked swabs collected then eluted in ThinPrep media and then tested on six different PCR-based HPV assays, and this was used as the basis for accreditation of this protocol as part of the National Cervical Screening Program in Australia. [25]. As the evidence-base for different combinations of devices and assays grows, there may be refinements to these requirements for component validation, but these are more likely to relate to evidence regarding how stability affects the sensitivity of the assays over time [15].…”

Section: Pcr-based Technologies For Hpv Testing Of Self-collected Spementioning

confidence: 99%

“…There appears to be a growing body of evidence suggesting an increased percentage of invalid specimens (likely due to a lack of endogenous material) in self-collected specimens compared to practitioner-collected samples. [7,25,[32][33][34] suggesting some women may agree to self-collect but actually not undertake the test. The presence of common inhibiting reagents, such as lubricants, is likely to be less frequent than when a speculum examination is undertaken.…”

Section: Hologic Aptimamentioning

confidence: 99%

“…Currently only Roche cobas HPV assays (cobas or cobas 4800) are being used in these national programs for self-collected specimens. In Australia the availability of self-collection was delayed by lack of any suitable clinically validated HPV assays having manufacturer validated claims for the use of self-collected specimens (on label use), which required laboratories to independently validate their self-collection protocols against paired clinician-collected specimens ( [25], other studies not published).…”

Section: Validated Assaysmentioning

confidence: 99%

See 1 more Smart Citation

Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

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In 2018, there were an estimated 570,000 new cases of cervical cancer globally, with most of them occurring in women who either had no access to cervical screening, or had not participated in screening in regions where programs are available. Where programs are in place, a major barrier for women across many cultures has been the requirement to undergo a speculum examination. With the emergence of HPV-based primary screening, the option of self-collection (where the woman takes the sample from the vagina herself) may overcome this barrier, given that such samples when tested using a PCR-based HPV assay have similar sensitivity for the detection of cervical pre-cancers as practitioner-collected cervical specimens. Other advantages of HPV-based screening using self-collection, beyond the increase in acceptability to women, include scalability, efficiency, and high negative predictive value, allowing for long intervals between negative tests. Self-collection will be a key strategy for the successful scale up of cervical screening programs globally in response to the WHO call for all countries to work towards the elimination of cervical cancer as a public health problem. This review will examine self-collection for HPV-based cervical screening including the collection devices, assays and possible routine laboratory processes considering how they can be utilized in cervical screening programs.

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Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study

Cited by 34 publications

References 36 publications

Self‑sampling for high‑risk human papillomavirus as a follow‑up alternative after treatment of high‑grade cervical intraepithelial neoplasia

Self‑sampling for high‑risk human papillomavirus as a follow‑up alternative after treatment of high‑grade cervical intraepithelial neoplasia

Reaching under‐screened/never‐screened indigenous peoples with human papilloma virus self‐testing: A community‐based cluster randomised controlled trial

Self-Collection for Cervical Screening Programs: From Research to Reality

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