Aptima® HPV assay
Nearly all sexually active women will have a HPV infection at some point in their lives. Though very few go on to develop cancer, the expression of E6/E7 indicates the likelihood of the presence of precancerous or cancerous cells in the cervix.
The Aptima HPV assay is a target amplification nucleic acid probe test for the in vitro qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of HPV in cervical specimens. The Aptima HPV assay does not discriminate between the 14 high-risk types below:
16
18/45
31
35
51
56
59
68
39
52
58
66
33
The test is indicated to screen women with ASCUS cytology (reflex testing) to determine the need for colposcopy, and to screen women for high-risk HPV types. The Aptima® HPV assay can also be used as a first-line primary screening test, with or without cervical cytology, to identify women at increased risk for the development of cervical cancer or presence of high-grade disease. This information with cytology and screening history, other risk factors, and professional guidelines may be used to guide patient management.
HPV mRNA vs DNA
The development of HPV-induced carcinogenesis is directly attributed to the presence of two oncoproteins, namely E6 and E7, which are encoded by HPVs.
HPV DNA must linearize to integrate into human DNA. During the opening of circular DNA in the process of integration, deletions may occur - L1, L2, E1, E2.
As E6/E7 region is always conserved, HPV assays that ONLY target the L1 region are at risk of false negative results. HPV DNA test targeting the L1 region missed 5% -10% of cervical cancers with adequate cellularity.
2
3
4
5
4.9%
of abnormal LBC samples tested positive for E7 type-specific PCR, were missed with L1 based PCR.
Aptima® vs Cobas
Aptima® HPV Assay showed significantly higher specificity and positive predictive accuracy than Cobas.
Cobas HPV testing revealed greater positive results in patients with benign or low-grade squamous intraepithelial lesions (LSIL) on biopsy
Reflected greater FALSE positives.
Aptima® vs HC2
Aptima® showed similar sensitivity BUT significantly higher specificity than HC2 in detecting cervical precancer.
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ASC-US and LSIL meta study
-
CIN2+ and CIN3+ meta study
Sensitivity (95% CI)
ACS-US Pooled values CIN2+
ACS-US Pooled values CIN3+
Hybrid Capture 2
93.8%
(89.8-96.2)
95.5%
(90.9-97.8)
Aptima HPV
95.7%
(91.5-97.2)
96.2%
(91.7-98.3)
A recently published meta-analysis of clinical data for Aptima HPV as compared to Digene Hybrid Capture (HC2) determined that the pooled sensitivity for Aptima among ASC-US patients was high.
FDA-approved and HSA-approved for use with ThinPrep®
Aligns with current WHO cervical cancer screening guidelines and Singapore guidelines*
Note: The assay is not a substitute for regular cervical cytology screening. The results of this test are not intended to prevent women from proceeding to colposcopy. The assay has not been evaluated for managing HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or have other risk factors. Aptima and other associated logos are registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States, and/or other countries.
*The updated national cervical cancer screening guidelines (Cervical Screen Singapore) released in 2019 recommend:
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Pap-smear for women aged 25-29 years who have ever had sexual intercourse every 3 years
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HPV primary screening for women aged 30 years and above every 5 years.
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Reflex testing of abnormal cytology results
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Optionally, co-testing with cervical cytology and HPV test can be performed every 5 years for women above 30 years. You can learn the benefits here.
References
1. Morris BJ. Cervical human papillomavirus screening by PCR: advantages of targeting the E6/E7 region. Clin Chem Lab Med 2005; 43(11):1171-7
2. APTIMA HPV Assay package insert AW-14517-001 Rev. 005 (EN) 2018
3. cobas 4800 HPV Test US Package Insert #05641268001-01EN Rev 1.0 20115.
4. Abbott Real Time High Risk HPV package insert #2N09 Rev 49-2028/R36.
5. Genomica CLART http://genomica.es/en/in_vitro_diagnostics_products_clart_hpv2.cfm
6. Walboomers JM et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189:12-192.
7. Depuydt CE et al. Thin-layer liquid-based cervical cytology and PCR for detecting and typing human papillomavirus DNA in Flemish women Br J Cancer 2003;88,560 – 566
8. Ge Y, Christensen P, Luna E, Armylagos D, Schwartz MR, Mody DR. Performance of Aptima and Cobas HPV testing platforms in detecting high-grade cervical dysplasia and cancer: Aptima and Cobas HPV Testing for ≥HSIL. Cancer Cytopathol [Internet]. 2017;125(8):652–7, http://dx.doi.org/10.1002/cncy.21875
9. Arbyn M, et al. "The Aptima HPV assay versus the Hybrid Capture 2 test in triage of women with ASC-US or LSIL cervical cytology: a meta-analysis of the diagnostic accuracy." Int J Cancer. 2013;132(1):101-108.
10. Arbyn, Marc et al. “2020 list of human papillomavirus assays suitable for primary cervical cancer screening.” Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases vol. 27,8 (2021): 1083-1095. doi:10.1016/j.cmi.2021.04.031
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