The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Heideman, Daniëlle A.M.; Hesselink, Albertus T.; Kemenade, Folkert J. van; Iftner, Thomas; Berkhof, Johannes; Topal, Fatih Esad; Agard, Denira; Meijer, Chris J.L.M.; Snijders, Peter J.F.

doi:10.1128/jcm.01517-13

Cited by 54 publications

(46 citation statements)

References 23 publications

(29 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The guidelines and criteria for HPV testing in primary cervical cancer screening have taken into account only DNA‐based tests so far , but the Aptima HPV assay also fulfills the cross‐sectional clinical and reproducibility criteria of international guidelines for human papillomavirus test requirements for cervical cancer screening . Our study shows that the performance of mRNA‐based Aptima assay did not differ from the widely used and well‐studied DNA‐based HC2 test.…”

Section: Discussionmentioning

confidence: 71%

Performance of mRNA‐ and DNA‐based high‐risk human papillomavirus assays in detection of high‐grade cervical lesions

Virtanen

Kalliala

Dyba

et al. 2016

Acta Obstet Gynecol Scand

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 71%

Performance of mRNA‐ and DNA‐based high‐risk human papillomavirus assays in detection of high‐grade cervical lesions

Virtanen

Kalliala

Dyba

et al. 2016

Acta Obstet Gynecol Scand

View full text Add to dashboard Cite

show abstract

“…12 Thus, our observed noninferiority of HPV-mRNA and similar sensitivities of the HPV-mRNA and HPV-DNA tests, as well as our population-based estimate of longitudinal NPV indicate that mRNA testing using the Aptima HPVassay is valid for primary HPV screening. In addition, several other studies have also indicated that the Aptima HPV assay is appropriate for cervical screening, 13 having similar sensitivities as a HPV-DNA based assay (Hybrid Capture 2, Qiagen) for detection of CIN2/3+, combined with higher specificity. 14 longitudinal NPV was taken from another county in Sweden (Stockholm) that used Cobas in the population-based HPV screening program.…”

Section: Discussionmentioning

confidence: 99%

HPV‐mRNA and HPV‐DNA detection in samples taken up to seven years before severe dysplasia of cervix uteri

Forslund

Elfström

Lamin

et al. 2018

Intl Journal of Cancer

View full text Add to dashboard Cite

Randomized clinical trials using human papillomavirus (HPV) DNA testing have found increased protection against cervical cancer and HPV-based screening is globally recommended for women ≥30 years of age. HPV-mRNA is a promising alternative target for cervical screening tests, but assessing equivalence requires longitudinal evaluation over at least the length of a screening interval. Our aim is to analyze the longitudinal sensitivity of HPV-mRNA and HPV-DNA in cervical samples taken up to 7 years before severe cervical intraepithelial neoplasia or worse (CIN3+). From a population-based cohort of 95,023 women in Sweden, cervical samples were frozen at -80°C between May 2007 and January 2012. Registry linkages identified that 1,204 of these women had CIN3+ 4 months to 7 years after enrolment. Baseline samples were analyzed for HPV-mRNA (Aptima, Hologic) and for HPV-DNA (Cobas 4800, Roche) and results from both tests obtained for 1,172 women. For both women <30 and ≥ 30 years, HPV-mRNA had similar sensitivity for CIN3+ as HPV-DNA (p = 0.0217 and p = 0.0123 in noninferiority testing for at least 90% relative sensitivity, respectively). Among women ≥30 years, the longitudinal sensitivities for CIN3+ occurring 5-7 years later were comparable [76.3% (95% CI: 65.8%-84.3%) and 82.5% (95% CI: 72.6%-89.4%)] as were the longitudinal negative predictive values for absence of CIN3+ [99.97% (95% CI: 99.95-99.98) and 99.98% (95% CI: 99.96-99.99)], for the HPV-mRNA and HPV-DNA test. In conclusion, HPV-mRNA testing has similar longitudinal sensitivity as HPV-DNA, implying that HPV-mRNA testing can safely be used for cervical screening.

show abstract

“…The use of APTIMA in primary screening was evaluated in several studies [5][6][7]22,23]. As mentioned earlier, APTIMA was compared to LBC and HC2 in 1109 women aged 20-29 years in the FASE study [5].…”

Section: Comparison With the Literaturementioning

confidence: 99%

“…However encouraging, these findings should ideally be confirmed by data from other studies. Unfortunately, other studies comparing APTIMA with HPV DNA assays in screening populations did not present data specifically for this age group [6] or did not ascertain histological results in women with positive HPV tests and normal cytology [7].…”

Section: Introductionmentioning

confidence: 98%

A daunting challenge: Human Papillomavirus assays and cytology in primary cervical screening of women below age 30years

Bonde¹,

Ejegod²,

Preisler³

et al. 2015

European Journal of Cancer

View full text Add to dashboard Cite

We compared cytology with Hybrid Capture 2 (HC2), cobas, CLART and APTIMA Human Papillomavirus (HPV) assays in primary cervical screening at age 23-29 years based on data from the Danish Horizon study. SurePath samples were collected from 1278 women undergoing routine cytology-based screening. Abnormal cytology was managed according to the routine recommendations, and women with cytology-normal/HPV-positive samples were invited for repeated cytology and HPV testing in 1.5 years. Loss to follow-up was similar between HPV assays. ⩾ CIN3 was detected in 44 women. The sensitivity of HC2 for ⩾ CIN3 was 95% (95% confidence interval (CI): 85-99), of cobas 98% (95% CI: 88-100), of CLART 100% (95% CI: 92-100), of APTIMA 82% (95% CI: 67-92), and of cytology 59% (95% CI: 43-74). Specificity for ⩾ CIN3 varied between 61% (95% CI: 59-64) for cobas and 75% (95% CI: 73-78) for APTIMA, and was 94% (95% CI: 93-96) for cytology. Similar results were observed for ⩾ CIN2 (N = 68). HPV screening with cytological triage doubled the number of colposcopies compared to cytology screening, and increased the frequency of repeated testing by four (APTIMA) to seven (cobas) times. The positive predictive value of a referral for colposcopy was relatively high for all screening tests (⩾ 30% for ⩾ CIN3, and ⩾ 50% for ⩾ CIN2). CIN1 was detected by cytology in ∼ 1% of women, and in ∼ 2% by any of the four HPV assays. Although highly sensitive, HPV-based screening of young Danish women should be approached cautiously, as it resulted in large reductions in specificity, and increased the demand for additional testing.

show abstract

The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Cited by 54 publications

References 23 publications

Performance of mRNA‐ and DNA‐based high‐risk human papillomavirus assays in detection of high‐grade cervical lesions

Performance of mRNA‐ and DNA‐based high‐risk human papillomavirus assays in detection of high‐grade cervical lesions

HPV‐mRNA and HPV‐DNA detection in samples taken up to seven years before severe dysplasia of cervix uteri

A daunting challenge: Human Papillomavirus assays and cytology in primary cervical screening of women below age 30years

Contact Info

Product

Resources

About