Performance of the Aptima High-Risk Human Papillomavirus mRNA Assay in a Referral Population in Comparison with Hybrid Capture 2 and Cytology

Abstract

This study compared the Aptima human papillomavirus (HPV) (AHPV; Gen-Probe Incorporated) assay, which detects E6/E7 mRNA from 14 high-risk types, the Hybrid Capture 2 HPV DNA (HC2; Qiagen Incorporated) test, and repeat cytology for their ability to detect high-grade cervical lesions (cervical intraepithelial neoplasia grade 2؉ [CIN2؉]) in women referred to colposcopy due to an abnormal Papanicolaou (Pap) smear. A total of 424 clinical specimens, stored in liquid-based cytology (LBC) vials at room temperature for up to 3 years, were tested by repeat cytology, the AHPV assay, and the HC2 test. Assay results were compared to each other and to histology results. The overall agreement between the AHPV assay and the HC2 test was 88.4%. The sensitivity (specificity) of cytology, the HC2 test, and the AHPV assay for the detection of CIN2؉ was 84.9% (66.3%), 91.3% (61.0%), and 91.7% (75.0%) and for the detection of CIN3؉ was 93.9% (54.4%), 95.7% (46.0%), and 98.2% (56.3%), respectively. Of the disease-positive specimens containing high-risk HPV (HR HPV) DNA as determined by Linear Array (Roche Diagnostics), the AHPV assay missed 3 CIN2 and 1 microfocal CIN3 specimen, while the HC2 test missed 6 CIN2, 4 CIN3, and 1 cervical carcinoma specimen. The AHPV assay had a sensitivity similar to but a specificity significantly higher (P < 0.0001) than the HC2 test for the detection of CIN2؉. The AHPV assay was significantly more sensitive (P ‫؍‬ 0.0041) and significantly more specific (P ‫؍‬ 0.0163) than cytology for the detection of disease (CIN2؉

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

“…Our findings are fully in line with those of other studies that compared the clinical performance of the Aptima HPV assay with that of a variety of commercially available HPV assays for ASC-US/low-grade squamous intraepithelial lesion triage or primary screening (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25). The current study adds because it addresses all aspects of the guidelines, including intralaboratory reproducibility over time and interlaboratory agreement of the Aptima HPV assay.…”

Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

“…Adjunctive testing to cytology, however, leads to reduced combined sensitivity. The AHPV test has also been suggested as the primary cervical cancer screening test in a few studies (10,13,14). HPV DNA screening, with certain requirements, has already been identified as an alternative option for primary cervical cancer screening (31)(32)(33).…”

“…However, the poor sensitivity of cytology demands the development of more-accurate screening schemes. Strategies for the improvement of early diagnosis of CIN2ϩ cases have been assessed for the AHPV assay based on the primary screening test being cytology (10)(11)(12)(13)(14)(15)(16)(17)(18). Adjunctive testing to cytology, however, leads to reduced combined sensitivity.…”

“…The AHPV assay detects the HPV E6 and E7 mRNA of the 13 HR HPV types targeted by the HC2 assay as well as the class 2B type HPV66 (9). The AHPV test has been compared previously to the HC2 test (10)(11)(12)(13)(14)(15)(16)(17)(18); however, only three studies were conducted in a routine screening population (12,14,18) and only two of those studies performed a split-sample comparison with liquid-based cytology (LBC) and the HC2 test (12,14).…”

Stability of Cervical Specimens in SurePath Medium for Human Papillomavirus Testing with the Roche cobas 4800 Assay

“…The growing body of knowledge over the past decades has led to the introduction of molecular tests for HR-HPV types into routine patient care, generally as an adjunct to Pap cytology (1)(2)(3)(4)(5)(6). The cobas 4800 HPV test (Roche Molecular Systems Inc., Pleasanton, CA) is a fully automated PCR assay for the detection of 14 highrisk HPV types.…”