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TEST:
Aptima® HPV Assay

Company:
Hologic
Type:
FDA Approved (PMA)
Related tests:
Evidence

News

19d
Cytomorphologic Findings Associated With High-Risk HPV Categories in PAP Smears. (PubMed, Diagn Cytopathol)
Our findings indicate that while cytomorphology alone is not fully adequate for precise hrHPV typing, it may offer supportive value, particularly in settings where HPV testing is not readily available.
Journal
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Aptima® HPV Assay
22d
HPValidate - Technical Optimisation of Self-Collected Samples for HPV Testing within the NHS England Cervical Screening Programme. (PubMed, J Virol Methods)
Following resuspension, samples showed high stability, with reproducibility ranging from (89.4%-100%). These data support the optimisation of laboratory workflows, acceptance criteria, and standardised HPV self-sampling protocols.
Journal
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Aptima® HPV Assay • cobas® HPV test
23d
RNA Extended Interventional Nucleic Acid (REINA) Longitudinal Study: Decreased Risk of CIN2+/CIN3+ With Low-Grade Cytology After A Previous Negative HPV Test. (PubMed, Cytopathology)
A previous negative Aptima mRNA HPV test confers a protective effect for CIN2+/CIN3+ in mRNA HPV-positive women with minor cytological changes. The adjusted risks impact patient management, decreasing colposcopy referrals.
Observational data • Journal
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Aptima® HPV Assay
2ms
Prevalence of vaginal microecological disorder and its association with HPV infections in pregnant women attending prenatal examinations. (PubMed, Microbiol Spectr)
Bacterial vaginosis, high Nugent score, and leukocyte esterase positivity were independently associated with HPV infection, whereas HPV vaccination offered protection. These results underscore the value of integrating vaginal microecological assessment and HPV testing into routine prenatal care.
Journal
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Aptima® HPV Assay
4ms
Hologic Receives FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio (Hologic Press Release)
"Hologic, Inc...announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic’s human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer."
Approval
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Aptima® HPV Assay